Ts 16949

Preface
Friday, November 09, 2012
16:00
Source for all information:

www.askartsolutions.com
Understanding The ISO/TS 16949:2002 Standard
Particular requirements for applying ISO 9001:2000 to automotive

production and relevant service part organizations
Preface
The intent of this document is to provide a clear and in-depth understanding of the intent
and implication of each clause and sub-clause of the TS 16949:2002 standard. While not
intended to serve as an implementation guide, this document should provide sufficient
insight for a quality practitioner to develop and implement an effective TS 16949 based
quality management system (QMS).
This document may be used by:
Beginners - to understand and apply TS 16949 requirements.
QMS managers – to develop a more effective QMS for their organization.
QMS auditors – to conduct more effective QMS audits.
Top management – to gain an understanding of TS 16949 as a business tool.
Consultants – to provide value-added service to their clients.
The specific requirements of the TS 16949:2002 standard is shown in shadedtext Within
this shaded background, the ISO 9001 foundational requirements are shown in regular
print and the TS 19649 additions are shown initalics. The wording of the ISO/TS 16949
requirements are laid out in paraphrased but precise form, following the exact clause by
clause numbering.
Where ISO/TS 16949 has used the word “shall”, it indicates a mandatory requirement. The
word ‘should’ indicates a recommendation and Certification Bodies (Registrars) lean towards
interpreting ‘should’ as a ‘shall’ in most cases. Notes to paragraphs are for guidance in
understanding or clarifying the associated requirement. However, if the note includes the
word ‘should’, then you would be wise to implement the guidance or recommendation in the
note. Wherever possible, I have stated the clauses in the active tense instead of the
sometimes difficult to understand passive tense used in the standard.
Below each section, clause or sub-clause of the standard, I provide key explanation
points and tips to help you better understand the requirement and any underlying intent,
concepts and principles. The key point or phrase in each explanatory paragraph
is bolded for easy reference to the sub-clause being explained. You will find important
explanatory points and tips being repeated or further elaborated in different parts of the
standard. Whenever I make reference to ‘you’ or ‘your’ QMS, I mean your
organization’s quality management system.
In going through the explanatory points and tips, I request that you read each paragraph
carefully and sometimes twice to fully grasp the additional interpretation or insight it may
convey. By doing so, you might be able to save much time, effort and money in
understanding and implementing these requirements or help make your QMS more
effective.
TS16949 Page 1
Introduction
16:45

Introduction
0.1 General:
The adoption of a QMS should be a strategic decision for your organization. Various factors
influence the design and implementation of your QMS. These include – varying needs;
particular objectives; products provided; processes employed and size and structure of the
organization. The ISO 9001 standard does not require uniformity of QMS structure or
documentation.
The QMS requirements specified in ISO 9001 are complementary to requirements for
product. Information marked “Note” is for guidance in understanding or clarifying the
requirement.
This international standard can be used by internal and external parties, including
certification bodies, to assess an organization’s ability to meet customer, regulatory and the
organization’s own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into
consideration in developing this standard.
Key Explanation Points and Tips:

 The purpose of an organization is to identify and meet the needs and expectations of its
customers and other stakeholders and gain competitive advantage. One of the strategies it
might use to achieve this goal is to continually improving the effectiveness and efficiency of
its capabilities.
 ISO 9001:2000 is a powerful business tool that organizations may use to achieve
this. Organizations use ISO 9001 to achieve goals and objectives related to meeting
customer and regulatory requirements and enhancing customer satisfaction.
 TS 16949:2002 is built upon all of the requirements, principles and concepts included in
ISO 9001, and goes further in specifying additional and supplemental requirements that are
specific to the automotive sector. We will continue with our introductory review of ISO 9001
concepts and principles before we get into the details of TS 16949 requirements.
 While the focus is on quality management, the ISO 9001 business model may be
applied just as well to manage the entire organization. The standard embodies business
concepts and principles universally recognized and applied for sound business management.
As such, ISO 9001 should be used as a strategic business management tool.
 The ISO 9001 standard defines a generic set of requirements for all organizations,
regardless of size, complexity or industry sector. These requirements define controls for
your quality management system that focus on continually improving the effectiveness of
your QMS in meeting customer requirements and thus enhancing customer satisfaction.
 It is important to note that the ISO 9001 standard does not specify requirements
for product. The focus of all ISO 9001 requirements is on your QMS and its processes. By
effectively controlling and continually improving your QMS processes, there will obviously be
a positive impact on product quality performance and conformity to customer
requirements.
 You must ensure that the scope of your QMS addresses all customer requirements.
TS16949 Page 2
Customer requirements may show up in contracts, blueprints, their supplier quality
manuals, or referenced to applicable industry and regulatory standards and codes, etc.
 It is important to state here that ISO 9001 certification must not be the ultimate goal of
QMS implementation. Your constant goal must be to continually improve the effectiveness
and efficiency of the organization for the benefit of all its stakeholders. Obtaining
certification must be considered as just a stepping stone in this journey. Organizations that
understand and follow this approach will get the most benefit from QMS development and
implementation.
 Organizations implementing an ISO 9001 based QMS must conform to all applicable
requirements that the standard specifies. This provides internal and external parties
(customers, registrars and regulatory bodies), the basis (i.e. a benchmark) against which to
assess the organizations ability to meet customer, regulatory and internal requirements.
 It is now a common practice to use ISO 9001 certification as a requirement for making
contractual decisions. The automotive OEM’s (subscribing to the TS 16949 standard) require
their direct (tier 1) suppliers of manufactured product and related services to obtain TS
16949 certification. Tier 1 suppliers in turn are required to flow down conformity to TS
16949 requirements through supplier QMS development.
 QMS design and implementation will vary from organization to organization. ISO 9001
allows this flexibility because organizations may have differing - goals and objectives;
business risks; range and complexity of products; processes and resources; organizational
size and structure; workforce competence and stability; etc. This flexibility may relate to
QMS scope; structure; documentation or application of ISO 9001 requirements.
 Personnel performing QMS assessments must - have adequate training on the
requirements of the ISO 9001 standard and auditing practices as defined by ISO 19011; be
familiar with your QMS, customer requirements and applicable regulatory requirements.
The guidance documents ISO 9000 and ISO 9004 provide the eight quality management
principles on which this standard is based. These are:
Principle 1 — Customer-Focus
Your organization depends on customers and therefore your organization should understand
current and future customer needs, meet customer requirements and strive to exceed
customer expectations (see clause 5.2; 7.2; and 8.2.1).
Principle 2 — Leadership
Leaders establish unity of purpose and direction of the organization. They should create and
maintain the internal environment in which people can become fully involved in achieving
the organization's objectives (see clause 5)
Principle 3 — Involvement of People

People at all levels are the essence of an organization and their full involvement enables
their abilities to be used for the organization’s benefit (see clause 6.2).
Principle 4 — Process Approach

A desired result is achieved more efficiently when related resources and activities are
managed as a process (see clause 4.1).
Principle 5 — System Approach to Management

Identifying, understanding and managing interrelated processes as a system contributes to
the organization’s effectiveness and efficiency in achieving its objective (see clause 4.1)..
Principle 6 — Continual Improvement

Continual improvement of the organizations overall performance should be a permanent
objective of the organization (see clause 8.5.1 and 4.1).
Principle 7 — Factual approach to decision making
TS16949 Page 3
Effective decisions are based on the analysis of data and information (see clause 4.1e and
8.4).
Principle 8 — Mutually beneficial supplier relationships

An organization and its suppliers are interdependent, and a mutually beneficial relationship
enhances the ability of both to create value (see clause 7.4).
 These eight management principles form the basis for all QMS standards within the ISO
9000 family which includes TS 16949:2002. All of these principles are included as
requirements in one or more clauses of the TS 16949 standard.
TS16949 Page 4
Major Clauses
16:46

Major Clauses - Contents of the TS 16949:2002 Standard
0. Introduction
1. Scope
2. Normative Reference
3. Terms and Definitions
4. Quality Management System
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis and Improvement
Many, if not most of the sub-clauses within the above major clauses can be traced to the
North American or European automotive standards – such as QS 9000 or Germany’s VDA
6.1.

The first four clauses (clause 0. Introduction to clause 3. Terms and Definitions) do not
provide any requirements for a QMS. They provide background information on the purpose;
concepts and principles used in the standard (e.g. process approach; PDCA); guidance on the
QMS scope; reference to related documents; and key terms and definitions used. These
clauses will all be explained in more detail as we go through each section.
The remaining five clauses numbering 4 through 8 provide the quality management
requirements that a QMS must implement. The following is a summary explanation of these 5
major clauses or elements of the ISO/TS 16949 standard. Each major clause has several sub-
clauses. Collectively, these five clauses set out the requirements for your QMS.
• Clause 4- Quality Management System - sets requirements to identify, plan, document,
operate and control QMS processes and to continually improve QMS effectiveness.
• Clause 5- Management Responsibility - sets requirements for top management to
demonstrate its leadership and commitment to develop, implement and continually
improve the QMS.
• Clause 6- Resource Management - sets requirements to determine, provide and control
the various resources needed to operate and manage QMS processes; to continually
improve QMS effectiveness; and to enhance customer satisfaction by meeting customer
requirements
• Clause 7- Product Realization - sets requirements to plan, operate and control the
specific QMS processes that determine, design, produce and deliver an organization’s
product and services.
• Clause 8- Measurement, Analysis and Improvement - sets requirements to plan,
measure, analyze and improve processes that demonstrate product and QMS conformity
and continually improve QMS effectiveness.
The overall objective of your QMS must be to enhance customer satisfaction by meeting their
requirements. This objective can be achieved by using the TS 16949 requirements to control
your QMS processes and by continually improving QMS effectiveness.
TS 16949:2002 requirements, structure and flow are built upon ISO 9001:2000 requirements
as the foundation. To clarify this, I show the ISO clauses in regular print and the TS specific
clauses in italics, both under the tan background.
The TS 16949 specific clauses may:
• Include new requirements over and above ISO 9001 requirements
TS16949 Page 5
• Supplement or expand on the existing ISO 9001 requirement
• Call for prescriptive ways to address ISO or TS requirements
To help you get the most out this e-Book, you might find it useful to follow key themes that
the TS 16949 standard has emphasized. These include:
• All QMS processes must be planned, implemented, measured and improved.
• TS 16949 requirements focus on controlling QMS processes, not product.
• QMS controls must emphasize prevention of nonconformities rather than detection.
• QMS processes focus on eliminating or reducing variation and waste in processes.
• QMS processes must be customer focused. Process personnel must be aware of and
strive to meet internal and external customer requirements.
• You must continually improve the effectiveness of your QMS.
TS16949 Page 6
Process Approach
16:46

0.2 Process Approach
This Standard promotes the adoption of a process approach when developing, implementing
and improving the effectiveness of a QMS, to enhance customer satisfaction by meeting
customer requirements.
For an organization to function effectively, it has to identify and manage numerous linked
activities. Any activity, using resources and managed in order to enable the transformation
of inputs into outputs, can be considered a process. Often the output from one process
directly forms the input to the next.
The application of a system of processes within an organization, together with the
identification and interactions of these processes, and their management, can be referred to
as the “process approach”.
Process Approach: Key Explanation Points and Tips:
 The process approach is the foundation upon which your QMS must be developed.
Let’s understand some basics about processes.
 Figure 1 - All work generally involves a process - things go in(inputs); get worked
upon (conversion); and come out differently(output). The value-adding conversion
activity within a process transforms inputs into outputs, e.g. takes raw materials (the input)
and manufactures (the value-adding conversion activity using various resources) a product
(the output).
 Process inputs and outputs can be tangible (raw materials or finished product) or
intangible (information – e.g. computerized drawing or specification).
 Figure 2 - All process has a supplier and a customer. These suppliers and customers
may be internal processes or external to your organization. Each process must have an
accountable owner, i.e., having defined responsibility and authority to operate, control and
improve their process.
 All processes require the use of resources, e.g. – people, equipment, materials,
technology etc. These resources can be used as inputs (raw materials or information such
as a customer specification) as well as for the value-adding conversion activity (e.g. use of
machinery, equipment, computers, technology, people, etc.) to transform raw material
(input) into finished product (output).
 All processes must meet (customer, organizational and applicable regulatory)

requirements. The performance of all processes can be monitored and measured. Gather
performance data that can be analyzed to determine process effectiveness and whether any
corrective action or improvement is needed.
 An organization’s processes may be grouped or categorized in manyways. One logical

way would include the following:
 Customer Oriented Processes (COP’s) - These are product realization processes
(see clause 7) that determine customer requirements (inputs), design, make and deliver
product (outputs) to customers and determine customer satisfaction. These processes
generally have the greatest degree of interaction with external customers. COP’s include -
marketing and sales; design and development; production; shipping; packaging; servicing/
warranty; customer satisfaction; etc., whether performed onsite or off-site.
TS16949 Page 7
 Support Oriented Processes (SOP’s) – These processes provide the necessary
resources to COP’s to facilitate product realization. These processes generally have the
greatest degree of interaction at an operational level with COP’s and to a lesser degree with
other internal QMS processes. SOP’s include - human resources; information technology;
purchasing and receiving; laboratory; maintenance; tooling; facility management; etc,
whether performed onsite or off-site. See clause 6 and 7.
 Management Oriented Processes (MOP’s) - These processes provide the
commitment, leadership, resources, review and decision-making by top management (see
clause 5). These processes generally interact with all QMS processes at the QMS planning
and review level. MOP’s include – business planning; management review; quality planning;
resource planning; communication, etc., whether performed offsite or on-site.
 Quality Management Processes (QMP’s) to document,measure, analyze and
improve all processes – These processes provide quality management support to and
interact with all QMS processes. QMP’s include - document control; records control;
monitoring and measurement of processes and product; internal audits; control of
nonconforming product; corrective and preventive action; continual improvement; etc
whether performed onsite or off-site. See clause 4 & 8.
 Outsourced Processes (OP’s) – These are COP’s or SOP’s that are performed by a
function or organization outside the ownership or managerial control of your facility. They
may be performed onsite or off-site. These processes include - heat treating; painting;
welding, calibration; testing; sort; HR; etc.
0.2 Process Approach (Continued)

An advantage of the process approach is the ongoing control that it provides over the
linkage between the individual processes within the system of processes, as well as over
their combination and interaction.
When used within a quality management system, such an approach emphasizes the
importance of:
a) understanding and meeting requirements
b) the need to consider processes in terms of added value
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.
Key Explanation Points and Tips: Process Approach
 Your QMS is made up of a network of value-adding processes that link, combine and
interact with one another to collectively provide product or service (See Figure 2). These
processes are inter-dependent and can be defined by complex interactions. For example,
any of the COP processes, could interact with some or all of the MOP’s, SOP’s; QMP’s. Also
note that resources (SOP’s) and QMP’s may also be applied to all other processes.
 Interactions between processes generally have the following characteristics:

 Typically involve the flow of information (data, discussion, decisions, documents,
etc.) or physical item (materials, product, supplies, resources, etc.).
 May take place between internal organizational processes; within a specific
process; or with external organizations (customers, suppliers, outsourcers, regulatory
bodies, Certification body (CB, etc.).
 May take place in many ways (e.g. human, computer, automated, etc. Interaction
between processes may take place sequentially or concurrently between several
TS16949 Page 8
processes.
 Interaction between processes may take place at any process stage – as an input,
output, process activity or resources needed for the process.
 Probably the root cause of many QMS process nonconformities could be traced to
breakdown in the communication or interaction between processes. For example the sales
function fails to notify the packaging function of a customer’s special packaging specification
and the product is packaged and delivered in the organizations default mode). Therefore
to control the interaction between and within processes, we need to identify and control:
 What is being communicated; who is communicating it; who is receiving

it; how is it being communicated; how will the data or item being communicated be
used; frequency and timeliness of data or item being communicated, etc.
 The controls should address the method of interaction or communication; its

completeness, reliability and quality; frequency; timeliness; approval;
understandability and usability of the data or item being communicated. Additionally,
the responsibilities of the transmitter and receiver must be clearly defined.
 Therefore, in general, in order to plan and implement your QMS using the ‘Process
Approach’, you must:
 Identify the processes needed for the QMS (see listing above)
 Determine their sequence and interaction (show the sequence and
interaction of your COP’s). There are many ways to document this, e.g., a flowchart or
a process map.
 Determine the application of QMS processes throughout the organization
(show how MOP’s; SOP’s and QMP’s are applied to each COP and to each other). There
are many ways of documenting this. A popular way is through graphical
representation, e.g. process maps.
 Determine (plan) the criteria, methods, information, controls and
resources needed for each QMS process. These include:
 Identify the internal/external customer-required output.
 Describe the process activity that produces the output.
 Identify the resources needed for the process activity.
 Identify the inputs for the process – information, materials, supplies, etc.
 Define the process methods, procedures, forms etc., that may be needed to
produce the output.
 Define the controls to prevent or eliminate risk of errors, omissions, or
nonconformities in the process activity. These controls may come from the TS 16949
standard; customer; regulatory and your own organizational requirements (more
details provided in clause 4.1).
 Interaction – with sources that provide the inputs (internal process or external
supplier); uses the output (internal process or external customer); or provide the
resources (internal support process) to perform the process activity.
 Implement your QMS according to your plan.
 Monitor, measure and improve each QMS process and itsinteraction with
other processes. Performance indicators to monitor and measure process performance
may come from the TS 16949 standard; customer; regulatory and your own
organizational requirements. Performance indicators may relate to the process output as
well as the process activity.
 Performance indicators for process output must focus on meeting customer and
TS16949 Page 9
regulatory requirements. Performance indicators for process activity should focus on
measuring process effectiveness and efficiency. See clause 5.4.2 for quality objectives.
 It is useful to point out that while we do need to identify all QMS processes and
describe their interaction, not all identified QMS processes need to be documented or
documented in the detail described above. Review notes on clause 4.1 General
Requirements in conjunction with the above notes on the process approach, for more insight
on process documentation.
 For those interested in gaining a deeper insight into understanding and implementing
the process approach, study the ISO guidance document on the concept and use of the
process approach for management systems - Document: ISO/TC 176/SC 2/N544R2(r),
issued 13 May 2004 on the ISO website. Also review the AIAG/IATF guidance on the
automotive approach to QMS processes on the IAOB website.
Keep in mind that the above notes and references are guidance documents and the manner
and detail of application and documentation of the ‘process approach’ will vary from
organization to organization, due to a variety of factors such as size and complexity of the
organization; products, processes; customers; etc. See clause 4.1 for more details on
applying the process approach.
TS16949 Page 10
PDCA
16:47

PLAN-DO-CHECK-ACT (PDCA) (Figure 3)
NOTE: In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied
to all processes. PDCA can be briefly described as follows.
Plan: Establish the objectives and processes necessary to deliver results in accordance
with customer requirements and the organization’s policies.
Do: Implement the processes
Check: Monitor and check processes and product against policies, objectives and
requirements for the product and report the results
Act: Take actions to continually improve process performance

 PLAN-DO-CHECK-ACT (PDCA) – is a very effective tool for business management
and the ISO 9001 standard strongly recommends its use. PDCA is a dynamic cycle that can
be applied toeach of the organization’s processes, and also to the system of processes as a
whole. It may be used to plan, implement, control and continually improve both product
realization and other QMS processes.
 Maintenance and continual improvement of QMS processes can be achieved by

applying PDCA to processes at all levels within the organization – from the executive high-
level strategic processes, such as business planning or management review to operational
processes such as product realization or calibration.
 (PLAN) - For each QMS process you must establish:
 Process owner and his/her accountability
 Process inputs, outputs, value adding or conversion activities and

sequence/interaction of these activities (sub-processes) within the process. Many of
the COP’s and SOP’s may have sub-processes.
 Process policies, responsibilities and accountability.
 Process objectives and performance indicators and methods to monitor and

measure process performance to these objectives and indicators.
 Resources needed (e.g. facility, equipment, labor, materials, time, etc).
 Preventive and detective controls needed for process activity, input, output and
resources used.
 Process documentation (e.g. procedures, forms, work instructions, specification,

etc.)
 The nature, method, frequency and timing of interaction with other processes and
where this interaction will occur – input, output, use of resources, conversion activity,
etc.
TS16949 Page 11
 You must pay a lot of attention to this stage of your QMS development. Planning must
also consider how you will meet customer, applicable regulatory, and your own
organizational requirements, in addition to ISO 9001 requirements. We will look at QMS
planning in more detail when we review clause 4.1 requirements.
 (DO) - Deploy and implement your QMS processes and manage and control them
according to your plan as documented above.
 (CHECK) – Monitor and measure the effectiveness of your QMS processes against
policies, objectives and performance indicators that you established under PLAN. Monitoring
and measuring activity may focus on any or all of a process’s inputs; outputs; use of
resources for conversion; and interaction with other processes.
 (ACT) – Collect and analyze your monitoring and measurement information and use it
to determine the effectiveness of each process as well as your overall QMS in meeting
requirements. Use the information to correct problems and continually improve individual
processes.
 As mentioned above PDCA is a dynamic cycle and so continual improvement must be

an on-going process for improving your QMS and enhancing customer satisfaction.
TS16949 Page 12
Continual Improvement Model
16:47

The Continual Improvement Model
The model of a process-based quality management system shown in figure 4illustrates the
process linkages presented in clauses 4 to 8. This illustration shows that customers play a
significant role in defining requirements as inputs.
Monitoring of customer satisfaction requires the evaluation of information relating to
customer perception as to whether the organization has met the customer requirements.
The model shown in Figure 4 covers all the requirements of this Standard, but does not
show processes at a detailed level.
 Figure 4 - shows the macro level application of the PDCA model to an entire
organization. The organization’s QMS (as depicted by the processes within the circle) is used
to PLAN the controls over all inputs, resources, value-adding activities and outputs. We
DO – implement our plan by using various resources to convert customer inputs
(requirements) into outputs (product) that meet customer requirements. We CHECK - by
monitoring and measuring QMS performance and through customer feedback. We ACT – by
using this information to continually improve QMS effectiveness. At the micro level, this
same model can be applied to each QMS process.
 Controls for your processes come from the ISO 9001 standard, customer
requirements, your organization or applicable regulatory requirements.. The five clauses of
ISO 9001 provide control requirements for PDCA - planning, implementation; monitoring
and measurement; and for improvement of each QMS process. The applicable requirements
of these five clauses must be applied to each process (inputs; outputs; resources used;
transformation activities; interaction with other processes) for effective control. In clause
4.1 we will discuss this in further detail.
TS16949 Page 13
Compatibility
16:48

Compatibility With Other Business Management Systems
0.3 Relationship with ISO 9004
The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of
quality management system standards which have been designed to complement each
other, but can also be used independently. Although the two standards have different
scopes, they have similar structures in order to assist their application as a consistent pair.
ISO 9001 specifies requirements for a quality management system that can be used for
internal application by organizations, or for certification, or for contractual purposes. It
focuses on the effectiveness of the quality management system in meeting customer
requirements.
ISO 9004 gives guidance on a wider range of objectives of a quality management system
than does ISO 9001, particularly for the continual improvement of an organization’s overall
efficiency, as well as effectiveness. ISO 9004 is recommended as a guide for organizations
whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of
continual improvement of performance. However, it is not intended for certification or for
contractual purposes.
NOTE Knowledge and use of the eight quality management principles referred to in ISO
9000:2000 and ISO 9004:2000 should be demonstrated and cascaded through the
organization by top management.
0.3.1 IATF Guidance to ISO/TS 16949:2002

This guidance document contains recommended automotive practices, examples,
illustrations and explanations, and provides assistance in the application to conform to the
requirements of TS 16949. This IATF guidance document is not intended for certification or
contractual purposes.

 The difference between ISO 9001 and ISO 9004 are as follows:
 The ISO 9001 standard provides requirements for your QMS that can be
certified by an accredited Registrar; whereas ISO 9004 provides guidance to
improve your QMS and is not subject to Registrar certification.
 ISO 9001 focuses on improving QMS effectiveness alone ; whereas ISO
9004 focuses on improving an organizations overall performance and
efficiency as well as its effectiveness.
 ISO 9001 provides the initial stepping stone for quality management;
whereas ISO 9004 takes you further down the road towards total quality
management .
 The scope of ISO 9001 focuses on requirements intended for certification
and contractual purposes; whereas ISO 9001 provides guidance that addresses
a broader range of stakeholders such as owners, community, personnel,
suppliers, investors, etc.
 The layout, structure and numbering sequence of the requirements in the two
TS16949 Page 14
documents are similar. ISO 9004 includes the requirements of the ISO 9001 standard in
boxed tables and further discusses concepts, principles, issues and ideas for QMS
development and implementation, for each clause.
 Keep in mind that ISO 9004 goes far beyond what may be required for initial ISO
9001 certification. Use it to gain knowledge and ideas, butbe careful about trying to
implement all that it covers, as it may be quite overwhelming if you are developing a QMS
for the first time. Use ISO 9004 to continually improve the effectiveness and efficiency of
your organization beyond certification.
 The eight quality management principles referred to in the note were

covered under clause 0.1 General.
 All of the automotive examples and explanations in the IATF ISO/TS 16949:2002
guidance document have been included in my key explanation points and tips for each sub-
clause.
0.5 Goal of ISO/TS 16949:2002

Your organization shall develop a QMS that:
l Provides for continual improvement
l Emphasizes defect prevention
l Reduces variation and waste in the supply chain
l Defines fundamental QMS requirements when coupled with customer-specific
requirements
l Provides a common approach to a QMS for automotive and service part organizations
l Is intended to avoid multiple certification audits

 Focus on defect prevention and continual improvement of your products,
processes, QMS and customer satisfaction
 Reduce variation and waste not only in your products, but also in
theprocesses within your organization. Encourage your suppliers to do the same.
 Analyze the business and quality risks associated with variables (such as materials,
labor, equipment, methods, etc) for each process within your QMS and take systemic
measures to prevent them from occurring.
 It is important to note that the TS 16949 standard does not specify requirements
for product. TS 16949 provides requirements for yourQMS and its processes. By effectively
controlling and improving your QMS processes, there will obviously be a positive impact on
product quality performance.
 Product specific requirements come from your customer; your own organization and
from applicable regulatory and industry standards and codes. TS 16949 QMS requirements
supplement the product specific requirements.
 By providing a common approach to automotive sector QMS requirements capable of
independent 3rd party certification, TS 16949 reduces the need for multiple OEM
requirements, systems and audits, thus reducing unnecessary work and cost in the supply
chain.
TS16949 Page 15
1.1 Scope
16:48

1. TS 16949 SCOPE
1.1 General
This Standard specifies requirements for your QMS to:
a) demonstrate your ability to consistently provide product that meets customer and
regulatory requirements
b) enhance customer satisfaction by:
c) effective application of your QMS
d) continual improvement of your QMS
e) providing assurance of conformity to customer and applicable regulatory requirements.
Note: The term “Product” applies to product intended for or required by a customer
This Standard in conjunction with ISO 9001:

• Defines QMS requirements for the design, development, production, installation
and servicing of automotive related products
• Is applicable to organizational sites where customer-specific product is
manufactured for production and/or service applications.
• Can be applied throughout the automotive supply chain
Support functions, whether onsite or remote (such as design centers, corporate HQ and
distribution centers cannot obtain stand-alone certification to TS 16949. They shall be
audited as part of the site they support.

 Your QMS must do two things – 1. Meet requirements consistently and 2. Enhance
customer satisfaction in three different ways (see above).
 Ability refers to the capability of your organization to – determine your customer
needs and requirements; design and develop product; know-how and capacity to
manufacture product; package product; deliver on time; provide service and support; etc;
 Consistency is being able to repeat your capability within specified parameters for
quality as defined by customers, your own organization or regulatory bodies. Can you
consistently make conforming product or service, day in day out?
 To achieve and demonstrate your capabilities, you must effectively plan, operate and
control the processes, within your organization that provide them. These processes
collectively form the scope of your quality management system (QMS).
 The effectiveness application of your QMS can be determined by - how well QMS
activities and results measure up to planned performance indicators.
 Continual improvement of the QMS is achieved by - increasing the ability of the QMS
to meet requirements through raising the performance indicators and more efficient use of
resources.
 Assurance of conformity to requirements may be achieved by providing confidence that
requirements will be fulfilled. This confidence may be achieved through – implementing
TS16949 Page 16
prevention based controls; conducting internal/external audits; 3rd party certification of your
QMS; etc.
 This standard provides specific requirements to effectively plan, operate, control and
improve your QMS processes. These requirements focus on prevention based controls and
to a lesser extent detection based controls, as well as continual improvement of your QMS.
 It is important to note that the ISO 9001 standard does not specify requirements
for product. The focus of all ISO 9001 requirements is on your QMS and its processes. By
effectively controlling and continually improving your QMS processes, there will obviously be
a positive impact on product quality performance.
 Don’t overlook regulatory requirements applicable to your organization. These
requirements may come from your customer; the industry you are in; from within your own
organization; or state or federal organizations. You may need to apply regulatory
requirements to your suppliers and outsourced processes (subcontractors).
 Your ultimate objective is to enhance customer satisfaction. You achieve this by
planning, operating and improving your QMS to effectively meet customer and regulatory
requirements. As this standard represents specific automotive OEM’s, your QMS must
provide objective evidence that your QMS processes can identify and manage these
requirements and that customer-specific requirements are effectively implemented.
 Scope (under this section) refers to the type of automotive supply chain facilities, TS
16949 is applicable to. “Automotive" includes cars, trucks (light, medium and heavy),
buses, motorcycles. It excludes industrial, agricultural, off-highway (mining, forestry,
construction, etc.). It includes all supplier ‘sites’ providing value-added parts, components,
products , sub-assemblies and services up the supply chain to the OEM. TS 16949
requirements may be applied to any site in the supply chain by its customer (see clause
7.4.1.2).
 TS 16949 applies to all supply chain facilities or ‘sites’ thatmanufacture production
materials; production and service parts; assemblies; or provide (value-added) finishing
services such as heat treating, welding, painting; etc., for the automotive OEM’s subscribing
to this standard.
 This means that all Tier 1 suppliers providing such products or services directly
to subscribing (see last paragraph below for OEM’s subscribing to TS 16949) automotive
OEM’s, must get TS 16949 certification and they in turn may flow TS 16949 conformity or
certification requirements down to Tier 2 suppliers and so on (see clause 7.4.1.2). The flow
down to tier 2 or 3 has now become more the norm than the exception.
 TS 16949 cannot be applied to:
 Automotive after-market service parts made to original subscribing OEM specifications,
but not procured and released through them.
 Manufacturers of tooling; production equipment; jigs; fixtures; molds; etc used by the
auto industry.
 Remanufactured automobile parts.
 Distribution centers; warehousers; parts packagers; logistics support; and sequencers.
 Determine whether your activities or location is a site or support function. Note that
the definition of ‘site’ (under clause 3.1 Terms and definitions) is a location where value-
added manufacturing occurs and asupport function is a value-adding non-
manufacturing process that supports a site. The support function may be on-site or at a
remote location.
 The rules for third party Certification Body (Registrar) auditing of sites and remote
locations are specified in an IATF document called “Automotive Certification Scheme for
ISO/TS 16949:2002 – Rules for achieving IATF recognition”. The general rule is
that sites may obtain stand-alone TS 16949 certification, but support functions, cannot
obtain stand-alone certification.
TS16949 Page 17
 Support functions may include a variety of non-manufacturing activities such as –
design; purchasing; HR; sales; distribution centers; warehousing; sequencing; logistics;
etc.
 All support functions (whether on-site or off-site) that support a site must be included
in that site’s QMS scope. As such they must be audited to all applicable TS 16949
requirements including their interaction with site activities.
 Both manufacturing as well as support activities may be outsourced(i.e. performed by
an independently owned organization, on your site or off-site). Organizations performing
outsourced manufacturing activity must be subject to the same TS 16949 requirements that
would apply if the activity were done by your organization. Such organizations can obtain
independent TS 16949 certification if required by their customers.
 Organizations performing outsourced support functions (e.g. warehousing or HR
services) may be subject to specific TS 16949 requirements imposed by their customers,
however they cannot obtain independent TS 16949 certification for such support activities.
They may obtain independent ISO 9001 certification. More on outsourcing under clause
4.1.
 The organizations subscribing to the TS 16949 standard include: General Motors; Ford;
Daimler Chrysler; Fiat; PSA Peugot-Citreon; Renault SA; FIEV: Opel Vauxhall; Audi; BMW;
VW; Mercedes Benz; etc. The Japanese OEM’s while participating in the development of the
TS 16949 standard, do not formally subscribe to it or require it of their supply chain.
TS16949 Page 18
1.2 Application
16:48

1.2 Application
All requirements of this Standard are generic and are intended to be applied to all
organizations, regardless of the type, size and product manufactured or supplied.
Certain requirements from this Standard may be excluded from your QMS, if they are
not applicable due to the nature of your organization and its product
You cannot claim conformity to this Standard unless your exclusions:
 are limited to sub-clauses within Product Realization (clause 7)
 do not affect your organization’s ability, or responsibility, to provide product that meets
your customer and applicable regulatory requirements
The only permitted exclusions to TS 16949 relate to clause 7.3 where the organization is
not responsible for product design and development.

 The scope of the QMS should be based on the nature of your organization's products
and realization processes, the result of risk assessment, commercial considerations, and
contractual, statutory and regulatory requirements.
 You must begin with the premise that all requirements of TS 16949 are generic and
applicable to your QMS. The only permitted exclusion is from clause 7.3, for product
design and development, if your organization is not responsible to any automotive
OEM for this activity . If you are not clear whether you are design responsible, contact
your customer and get clarification in writing. You must includemanufacturing process
design and development in the scope of your QMS.
 Note that if you are exempt from product design and development for automotive
clients, but design product for non-automotive customers, you must include 7.3 product
design and development in your QMS scope.
 A clause may be non-applicable in situations where the process exists, but is not
currently applicable – e.g. No customer owned tooling exists at the audited site, or there is
no written servicing agreement between the customer and your organization. In such cases,
plan and document the necessary process controls and implement it when a customer
contract requires the use of that process.
 Your product scope must include all products supplied to customers subscribing to TS
16949 .
 If you manufacture product for the non-automotive sector, then many of the ISO
9001 and TS 16949 requirements may not be applicable to such products. However, for
consistency and overall control, it may bebeneficial to apply TS requirements across the
board to all products. There are several factors entering this decision. Check with a good
consultant or your Certification Body (CB).
 Your Quality Manual must clearly specify the scope of your QMS.(see clause 4.2.2).
Your QMS scope must include –products and services; processes; sites; support
functions/locations; any exclusion from the TS 16949 standard with justification; etc.
 IATF guidance requires that Design and Development activities onsite or remote
TS16949 Page 19
must undergo surveillance audits at least once within each consecutive 12 month period.
Consult with your Certification Body (Registrar) for details.
TS16949 Page 20
2 Normative Documents
16:49

2 NORMATIVE REFERENCE DOCUMENTS
The following documents contain provisions, which through reference in this text, constitute
provisions of this Standard:
ISO 9000:2005 – Fundamentals and vocabulary
Use the latest edition of the document referred to above as well as documents referred to in
the text.

In developing and auditing your TS 16949 based QMS you must use several reference
documents. The documents that are directly or indirectly (customer specified) referred to in
TS 16949 include:
 ISO 9001:2000 Standard – Quality Management System requirements (QMS)
 Customer specific requirements – Ford, GM, Daimler/Chrysler, major European
automotive OEM’s, etc. (see their websites). Also see the notes under clause 1.1 scope
(general) for a list of automotive OEM’s subscribing to TS 16949.
 Rules and interpretations published by the OEM’s, IAOB & IATF on their websites.
 Reference documents such as:
 APQP and Control Plan
 PPAP; FMEA; MSA; SPC;
 IATF Guidance to ISO/TS 16949:2002
 IATF Automotive Certification Scheme for ISO/TS 16949. Rules for achieving IATF
certification
 ISO/IEC 17025 – Laboratory requirements
 Only the terms and definitions (section 3) of ISO 9000:2000 apply to ISO 9001:2000
 In developing your TS 16949 QMS, all of the documents listed in the scope
above must be considered. The TS 16949 standard is the generic set of requirements of all
subscribing automotive OEM’s. The OEM customer-specific requirements come from all
these other documents. These customer-specific documents provide - interpretations of,
supplement to, or prescriptive methods for implementing TS 16949 requirements. If in
doubt about the applicability of any requirement or document, always check with your
customer and/or your CB.
 You must ensure that the scope of your QMS addresses all customer requirements.
Customer requirements may show up in contracts, blueprints, their websites, upline OEM
programs, their supplier quality manuals, associated industry standards, etc.
 Customer requirements may also come indirectly, from organizations representing the
automotive industry. Keep up to date with IAOB (International Automotive Oversight Board)
and IATF (International Automotive Task Force) requirements – browse through their
websites or subscribe to and keep abreast of all their latest changes and interpretations.
Their rules and interpretations may apply to you if you are an automotive supplier - as a
Tier 1 supplier or lower down the supply chain.
TS16949 Page 21
 Ensure that your internal and external auditors are adequately trained on:
 all aspects of your QMS,
 your customer requirements and referenced documents
 auditing practices as defined by ISO 19011 and IATF guidance documents.
Watch out for those reference documents – make very sure you have the latest
versions and use them as applicable. If there have been any significant changes to them,
make sure you update the training of personnel using these documents.
TS16949 Page 22
3 Terms and Definitions
16:49

3 TERMS AND DEFINITIONS
Terms and Definitions
l New “supply chain” terms:
supplier  organization  customer
l Use of “product” can also mean “service”
3.1 Terms and Definitions for the automotive industry

For the purposes of this Standard the terms and definitions given in ISO 9000:2000 and the
following apply:
3.1.1 Control plan
documented description of the systems and processes required for controlling product (see
annex A for an example of a Control Plan). (See clause 7.5.1.1 and 7.3.6.2)
3.1.2 Design responsible organization
organization with authority to establish a new, or change an existing product specification.

(See clause 7.3)
NOTE This responsibility includes testing and verification of design performance within the
customer’s specified application.
3.1.3 Error proofing
product and manufacturing process design and development to prevent manufacture of non-
conforming products.(See clause 7.3.3.1 and 7.3.3.2)
3.1.4 Laboratory
facility for inspection, test or calibration that may include, but is not limited to, chemical,
metallurgical, dimensional, physical, electrical or reliability testing.
3.1.5 Laboratory scope
controlled document containing the following:

o specific tests, evaluations and calibrations that a laboratory is qualified to perform,
o list of the equipment which it uses to perform the above,
o list of methods and standards to which it performs the above.
3.1.6 Manufacturing
process of making or fabricating :

o production materials,
o production or service parts,
o assemblies, or
o heat treating, welding, painting, plating or other finishing services.
TS16949 Page 23
3.1.7 Predictive maintenance
activities based on process data aimed at the avoidance of maintenance problems by

prediction of likely failure modes.
3.1.8 Preventive maintenance
planned action to eliminate causes of equipment failure and unscheduled interruptions to

production, as an output of the manufacturing process design.
3.1.9 Premium freight
extra costs or charges incurred additional to contracted delivery.
NOTE Caused by method, quantity, unscheduled or late deliveries.
3.1.10 Remote location
location that supports sites and at which non-production processes occur.
3.1.11 Site
location at which value-added manufacturing processes occur
3.1.12 Special characteristic
product characteristic or manufacturing process parameter which may affect safety or

compliance with regulations, fit, function, performance or subsequent processing of product.

 A supplier is an organization that supplies your organization with product or services,
e.g., a distributor, retailer or vendor. A supplier can be internal or external to your
organization.
 In this standard, wherever the term ‘organization’ is used, it refers to your facility and
includes the people and resources with associated responsibilities, authorities and
relationships.
 Customer refers to a person or organization to whom you provide product and services.
A customer can be internal or external to your organization.
 Product is used in a broader context and includes service.
 The definition of manufacturing under TS 16949 includes OEM assembly centers
 The definition of manufacturing under TS does not include:
 The manufacture of tooling, jigs, fixtures, molds, equipment used for automotive part
manufacture or assembly.
 The manufacture of non-OEM aftermarket service parts
 Distributers, warehousers, sequencers, etc, of automotive product
 Remanufactured parts
 Laboratories testing product or calibrating test/inspection equipment
 Accordingly, all such product that does not fall within the TS definition of
“manufacture” would not be required to get TS 16949 certification. More likely, the OEM’s or
automotive customer may require certification to ISO 9001:2000, ISO 17025 or other
alternate standard. Also see notes under clause 1.1 General.
 Most of these definitions relate to specific clauses within TS 16949 that call for detailed
requirements to be met and so will be discussed when we cover the requirement.
TS16949 Page 24
4.1 General Requirements
16:50
4 QUALITY MANAGEMENT SYSTEM
4.1 General Requirements

Establish, document, implement and maintain your QMS and continually improve its
effectiveness in accordance with the requirements of this standard. Your organization shall:
a) Identify the processes needed for your QMS and also identify where they are applied
throughout your organization.
b) Determine the sequence and interaction of your QMS processes.
c) Determine the criteria and methods needed to ensure both the effective operation and
control of these processes
d) Ensure resources and information are available to support the operation and monitoring
of all QMS processes
e) Monitor, measure, and analyze your QMS processes
f) Implement actions to achieve planned results and continually improve your processes
Manage your QMS processes in accordance with the requirements of this Standard
Control any outsourced processes that affect product conformity to requirements & identify
such processes within your QMS
Note: Your QMS processes should include processes for management activities, provision of
resources, product realization, and measurement as part of QMS
4.1.1: Supplemental – outsourcing of processes does not absolve your company of

responsibility to conform to customer requirements. (see clause 7.4.1; 7.4.1.3; 7.3.6.2;
7.5.1.5).

 The primary focus of clause 4.1 requirements is to manage and controlall your QMS
processes including product realization processes. The note under clause 4.1 requires that
your QMS must also include processes for management activities, provision of resources,
product realization, and measurement as part of QMS.
 Clause 4.1 requires the ‘Process Approach’ to be used in defining your QMS. Review
section 0.2 Process Approach of this document for a good understanding of clause 4.1
requirements and how they may be applied.
 Documentation of QMS processes and the need for and detail of specific process
documentation is determined by – ISO 9001; customer; regulatory and your own
organizational requirements. Other factors to consider may include - complexity of products
and processes; effect on quality; risk of customer dissatisfaction; economic risk;
effectiveness and efficiency; competence of personnel. Clause 4.2.1d requires you to have
documents needed to ensure the effective planning, operation and control for QMS
processes.
 Based on these factors, you must determine what processes need to be documented
and how you will document it. Not all identified QMS processes need to be documented;
however your quality manual must include a description of the interaction between your
TS16949 Page 25
QMS processes.
 A number of different methods can be used to document processes (each with varying
degrees of detail), such as graphical representations, written instructions, spreadsheets,
checklists, flow charts, visual media, or electronic methods, etc. Process flowcharts or block
diagrams can show how policies, objectives, influential factors, job functions, activities,
material, equipment, resources, information, people and decision making interact and/or
interrelate in a logical order.
 Procedures may be an acceptable way to document processes provided they describe
details of inputs and outputs, appropriate responsibilities, controls and resources; and
process performance indicators needed to satisfy customer requirements.
 Regardless of whether or not you document all of your processes, you must provide
evidence of effective implementation of all your QMS processes. Such evidence does not
necessarily need to be documented and may be demonstrated.
 Clause 4.1c requires you to determine criteria for effective process operation and
control. Specific criteria may be needed to control inputs, outputs and resources used.
 For example - raw materials as an input to production would have acceptance criteria
that it must meet before it can be used; finished product as an output of the production
process must meet acceptance criteria before it can be shipped to the customer;
the equipment used to transform raw materials into finished product may have set-up and
capability criteria or parameters that it must meet in order to produce conforming product.
These prevention based criteria (controls) must be established for each QMS process. Note
that such controls may also come from the customer, regulatory or industry bodies.
 Equally important are the specific methods (clause 4.1c) required for effective
operation and control of each process. These may include job travelers; work instructions;
in process inspection sheet; specifications and drawings; SPC charts; set up checklist;
machine manuals; etc. Note these control methods may apply to any or all of process
inputs, outputs or conversion activities.
 Under 4.1d - resources for QMS processes may include – facility, material;
equipment; labor; supplies; utilities; etc. Every QMS process will require a different
combination of resources. Resource details may be identified in specifications; production
schedules; bill of materials; production travelers or routers, work instructions, etc. The
planning of resources will be determined in MOP’s (clause 5) and provision and control of
resources will be determined by SOP’s (clause 6).
 Clause 4.1d- information for QMS processes will vary from process to process and
may include – production schedules; bill of materials; product acceptance and process
performance criteria; production traveler or router; work instructions; etc. Use clause 4.2.3
and other relevant clauses to control process information.
 Clause 4.1e requires you to monitor and measure your QMS processes. Clause 8
provides requirements to plan and implement these controls for monitoring and measuring
conformity to process performance criteria determined in 4.1c above. Measurement and
monitoring processesmay include – tracking against process parameters, goals and
objectives, using tools and records such as process check-sheets; product acceptance
criteria; SPC records; production records; maintenance records; labor records, etc. More
details on monitoring and measuring controls are covered in clause 8. QMP’s typically
perform this function (see section 0.2 Process Approach of this document).
 Clause 4.1e - Analysis of QMS processes may be done through a review of
measurement and monitoring records and performance indicators. These reviews must
identify opportunities to improve QMS processes, use of resources and product quality. See
clauses 8.2.3 and 8.4 for more insight on process monitoring, measurement and analysis.
 Under clause 4.1.f, when process nonconformities occur (as shown by process
performance indicators), then corrective action is required to bring the QMS process under
control. Remember, the corrective action process is not just for product related
TS16949 Page 26
nonconformities.
 Processes must be continually improved (see clause 4.1f) through setting realistic,
measurable (see clause 5.4.1) objectives- Planning for continual improvement requires a
review of process data, resources and controls to bring about the desired change. More on
this when we look at clause 8.4.
 Clause 4.1a – 4.1.f must be applied to all QMS processes. Note also that many TS
16949 clauses (e.g. clause 7.2; 7.4; 7.6; etc.), require specific processes to be identified
and controlled in your QMS. I will highlight all these process as we cover the standard.
 Make sure you include all outsourced processes affecting product quality, in the
scope of your QMS. An outsourced process is any value-adding activity related to your
product or service, that is performed by an external organization such as a subcontractor,
sister facility, etc. Note that the external organization may perform the outsourced activity
at their facility or yours. A manufacturing company may outsource welding, heat treatment
or painting of product. A software company may outsource replication and packaging of its
software product. A bank may outsource check clearing services.
 You must be able to demonstrate sufficient controls over outsourced processes to
ensure that such processes are performed according to the relevant requirements of TS
16949. The nature and scope of such control will depend on the nature of the outsourced or
subcontracted process and the risk involved.
 Outsourced processes may be controlled in any number of ways, e.g., providing the
outsourcer with product specifications; your supplier quality manual that they must meet;
asking for inspection and test results or certificates of compliance; validation of outsourced
process; conducting product and QMS audits of your outsourcer; etc. The expectation here
is that you flow down to your outsourcer, the relevant TS 16949 requirements that you
would have to implement, had you performed the process at your own facility. (also see
notes under clause 1.1 and clause 7.4.1 to better understand control of outsourcing).
 One last thing before we leave this all important clause. In systematically applying
clause 4.1 requirements to each QMS process, we are intuitively using the PDCA
approach to development of QMS processes.
 PLAN will call upon sub-clauses 4.1.a – 4.1e as well as other applicable TS 16949
clauses as shown above;
 DO is required by 4.1.f as well as other applicable TS 16949 clauses
 CHECK is controlled by 4.1.e as well as other applicable TS 16949 clauses;
 ACT is governed by clause 4.1.e-f as well as clause 8.
 Please review clause 4.1 and section 0.2 Process Approach of this
document several times as you go through the rest of this standard.
 With a bit of process-mapping practice with the different types of processes, you will
understand better the above explanation points and tips and will be able to develop and
implement an effective QMS. There are also many useful tools available to facilitate this.
 The above paragraphs covering control of outsourcing also apply toprototype
programs (see clause 7.3.6.2) and management of production tooling (see clause
7.5.1.5).
 Under TS 16949 clause 4.1.1 you cannot delegate technical responsibility for your
product to your outsourcer. You must provide direction, control and monitor all phases of
outsourcers supervise technical work – continuous interaction, reviews, inspections and
approvals.
You must flow down your customers PPAP requirements to those organizations you
outsource to.
TS16949 Page 27
4.2.1 Documentation Requirements
16:50
4.2 Documentation Requirements
4.2.1 General
QMS documentation shall include:
a) Statements of a quality policy and quality objectives
b) A quality manual
c) Documented procedures required by the Standard
d) Documents needed by the organization (to ensure effective planning, operation, and
control of QMS processes)
e) Records required by the Standard
Note 1 – Where the term ‘documented procedure’ appears within the standard, this means
that the procedure is established, documented, implemented, and maintained.
Note 2 – The extent of QMS documentation may differ from one organization to another
due to the:
a) size of organization and type of activities
b) complexity of processes and their interaction
c) competence of personnel
Note 3 - Documentation may be in any form or type of medium

 Let’s begin with some definitions. A document is information that iswritten or
recorded on some medium such as paper or computer. A document may specify
requirements (e.g. a drawing or technical specification); provide direction (e.g. quality
plan); or show results or evidence of activities performed (e.g. records).
 A procedure is a specific way to perform an activity or process (methods or practice
used by an organization) and it may or may not be written. If it is written, it is called
a documented procedure. The same reasoning applies to work instructions which may or not
be documented.
 This standard is not heavy on documented (written) procedures as was the case with
previous standards. Clause 4.2.1 specifies all the different types of documentation needed
for your QMS. The need to have additional documentation beyond those specified in this
standard may depend upon - customer; regulatory and your own organizational
requirements. Other factors to consider may include - complexity of products and
processes; effect on quality; risk of customer dissatisfaction; economic risk; effectiveness
and efficiency; competence of personnel; etc.
 The documents you must include in your QMS are those needed to ensure the effective
planning, operation and control for QMS processes (Clause 4.2.1d). Each organization
must determine what documentation is needed to achieve this based upon the factors listed
TS16949 Page 28
above.
 Make a list of all documents required by your QMS, regardless of the media or source
of the document. This list may include documents from customers; suppliers;
subcontractors; outsourcers; from within your organization; industry and regulatory bodies;
registrars; etc. It is this list of documents that is subject to clause 4.2.3 control
requirements.
 You must have documented statements of your quality policy and objectives.
These will be discussed later in clause 5. There are many ways to document your Quality
Manual and would be determined by the size, structure and complexity of your organization
(se note 2). Clause 4.2.2 specifies more requirements for the contents of the quality
manual.
 Regardless of how you document your QMS, you must demonstrate the effective
implementation of your QMS in terms of conformity to TS 16949, customer, regulatory and
your own organizational requirements.
 Under TS 16949, you must have documented procedures for - clause 4.2.3 - Control
of documents; clause 4.2.4 - Control of records; clause 6.2.2.2 - Training; clause; clause
8.2.2 - Internal audit; clause 8.3 - control of nonconforming product; clause
8.5.2 - Corrective action and clause 8.5.3 - Preventive action. Procedures are also
mentioned in other clauses such as 7.3.6.3; 7.6.3.1 and 7.5.2c, but the standard does not
specify that these be ‘documented’ procedures. However, it might add value to some
organizations to document these requirements.
 Depending on your organizations size, complexity, competency, etc, (see note 2) you
may decide to have additional procedures or carry over some or all the procedures you had
under previous QMS systems. Note there are several ways to write procedures, other than
the conventional narrative form.
 You may choose to include your procedures and lower level documentation in your
quality manual or organize them in some other fashion. The practicality of this would
depend on the size of your organization, complexity of products and processes; competency
of personnel, media used for documentation (hard copy versus computerized); ease of use
and understanding by personnel; maintainability; etc. (see note 2).
 In addition to the documents specifically called out in TS 16949, clause 4.2.1d call
for documents deemed necessary for effective management and control of your processes,
e.g. material specifications; competence criteria, product specifications, packaging
specifications, manufacturing specifications, work instructions; forms; schedules; set-up
specifications, etc. See note 2 below.
 TS 16949 calls for many records to provide evidence of effective planning, operation
and control of processes. Examples include – management review records; calibration
records, internal audit records; corrective action records, etc. As we go through this
standard, we will highlight these records. Again, your processes may call for additional
records beyond those expected by TS 16949.
 Many clauses do not specifically call for documents and records, but there is a strong
implication in the wording of the need to have them. This is where clause 4.2.1d and 4.2.1e
as well as 4.2.4; 7.1b and 7.1d kick in. In defining your processes and controls, you must
indicate what evidence you will have to demonstrate effective planning, operation and
control.
 Under Note 1 above it says ‘documented procedures’ must be established,
documented, implemented, and maintained. This is done by following the requirements
under clause 4.2.3 control of documents
 Note 2 - provides guidance on the extent of documentation your organization must
have. This will vary from organization to organization according to the criteria indicated.
Other criteria that may also affect the extent of documentation may include – impact on
quality; risk of customer dissatisfaction; customer regulatory, and industry requirements;
TS16949 Page 29
workforce stability and past quality problems and nonconformities. For example, if you have
a highly educated and stable workforce, then the amount of documentation needed may be
significantly less than an organization that has a high turnover of its workforce and lower
educational requirements.
Any combination of media is acceptable for documents and records provided they conform
to requirements specified in clause 4.2.3 control of documents and clause 4.2.4 control of
records
TS16949 Page 30
4.2.2 Quality Manual
16:50

4.2.2 Quality Manual
Establish and maintain quality manual & include:
a) Scope of the QMS including details of and justification for any exclusions
b) Procedures (or references to the procedures)
c) Description of interaction between QMS processes

 The quality manual is a special type of document that describes your QMS. Besides
describing your QMS, your quality manual could provide information on organizational
background and capabilities. It may be used by customers, regulatory bodies, suppliers and
company personnel for a variety of purposes. There are many acceptable ways to document
your quality manual.
 You must define the scope of your QMS in your quality manual. Your
QMS scope should include – facilities (manufacturing and support locations), products,
processes, your agreement to conform to TS 16949 and other business management
standards, etc. Customers will want to know the extent of your capabilities and the
Registrar will want to determine the time and effort needed to audit your organization.
 Provide details of any clause exclusions from your scope, e.g. 7.3 Product Design and
Development, and justification for it, i.e. no OEM customer has designated your
organization as being design responsible.
 You have flexibility in whether or not to include your procedures and lower level
documentation with your quality manual or organize them in some other fashion. You may
include all or some of your procedures in your Quality Manual or reference them to your
Quality Manual. Keep a listing or index at the front or back of your Manual showing the
complete list of your procedures whether included or referenced.
 The practicality of how you organize your QMS manual and related documentation
would depend, of course, on the size of your organization, complexity of products and
processes; competency of personnel, media used for documentation (hard copy versus
computerized); ease of use and understanding by personnel; etc. So go ahead and organize
your documentation to facilitate easy of use; availability and maintainability.
 Your quality manual must include a description of the interaction of your QMS
processes. This was discussed above under clause 4.1
 As a controlled document (see 4.2.1), the quality manual is subject to all of the
controls in clause 4.2.3.
TS16949 Page 31
4.2.3 Control of Documents
16:51

4.2.3 Control of Documents
l Control all documents required by your QMS
l Have a documented procedure that defines controls needed to:
a) Approve the adequacy of documents prior to issue
b) Review, update as necessary, and re-approve documents
c) Identify changes to documents as well as identify their current revision status
d) Make relevant versions of applicable documents available at points of use
e) Maintain documents so that they are legible and readily identifiable
f) Identify documents of external origin and control their distribution
g) Prevent the unintended use of obsolete documents, and apply suitable identification to
these documents if they are kept for any purpose.
Records are a special type of document (controlled by requirements in clause 4.2.4
4.2.3.1 Engineering Specifications

 Have a process to timely review, distribute and implement all customer engineering
standards/specifications & changes based on customers schedule
 These reviews should be as soon as possible and shall not exceed two working weeks
 Keep a record of the date that each change is implemented in production.
Implementation shall include updated documents
Note – PPAP’s need to be updated for changes in specifications referenced on the design
record or for changes to PPAP documents such as Control Plans, FMEA’s, etc. (see 7.1.4).

 As mentioned in clause 4.2.1 notes, a document is information that iswritten or
recorded on some medium such as paper or computer. A document may specify
requirements (e.g. a drawing or technical specification); provide direction (e.g. quality
plan); or show results or evidence of activities performed (e.g. records).
 Clause 4.2.1 tells you what documents you must include in your QMS. All documents
that you determine under clause 4.2.1 to be needed for your QMS processes must be
controlled. This clause 4.2.3 provides requirements on how these documents must be
controlled. Documents outside the QMS need not be subject to these controls.
 This clause requires you to have a documented procedure. Your procedure must -
define responsibility for and description of the controls required by 4.2.3 a – 4.2.3g;
methods to measure document control process performance; and continual improvement of
the document control process.
 Ensure that your procedure specifically addresses each of the control requirements, in
terms of who, what when, where and how as applicable. Your procedure must address new
and old as well as internal and external documents used by the QMS.
TS16949 Page 32
 You must review your QMS documentation and determine if anyupdating or
revisions are needed, and if they are changed, they must be re-approved. The frequency
of this review, responsibility and method must be defined in your procedure. This will be
determined by events within your organization and how mature or recent your QMS is.
Auditors will explore this if your documents have not changed in years, while the nature of
your business has changed significantly.
 Identify changes made to documents so users know exactly what has changed.
There are many ways of doing this on printed as well as computerized documents. Your
procedure must cover how this done.
 Have a method for revision control such as a revision log and masterlist of
documents which identifies the current revision status. Again, there are other ways of doing
this as well. Your procedure must cover how this done.
 Not all documents need to be available everywhere within your organization. You must
determine what document is applicable (i.e. needed to assure product or process quality)
to a specific process or activity and make the relevant version of that
document available to that activity, e.g. providing current packaging and shipping work
instructions to the shipping department. Also see clause 7.5.1.2 on accessibility of work
instructions at work stations). Your procedure must cover how this done.
 Once you determine that certain documents need to be made available at various
locations, implement some form of distribution control. There are many ways to do this.
One way would be to keep a distribution log. Your procedure must cover your form of
distribution control.
 Documents can take a beating in very harsh environments (covered in oil, dust, acid
eaten, weather-beaten, etc.) to the point of being illegible. You must regularly review the
condition of frequently used hardcopy documents to determine whether they need to be
replaced. Your procedure must cover how this done.
 Documents must also be readily identifiable as to its purpose and scope. A simple
heading may suffice, (e.g. In-process Inspection Sheet). Computerized documents are
sometimes given file names that don’t identify its contents and this might require numerous
files to be opened before you find the right one. Identification also implies effective filing
for timely retreival, whether manual or computerized. A frequent nonconformity is not being
able to retrieve a document or record because of poor filing procedures.
 External documents (such as customer drawings or supplier material/part
specifications) must be identified. There are many ways to do this. One way would be to
keep a manual or computer list of these documents. Determine who needs them and have
some form ofdistribution control to users to ensure they have the current or relevant
versions of external documents. Your procedure must cover how this done. Review specific
requirements for documents at OEM customer or IATF websites.
 Don’t overlook supplier, regulatory or industry documents. Apply applicable controls to
these as well (4.2.3f).
 Obsolete documents can cause many problems if not controlled. There are many ways
to do this. One way would be to provide computerized documents in read-only mode and
make only the current version accessible at workstation computer screens. Obsolete
hardcopy documents can be removed through distribution control. Your procedure must
cover how this or other methods are used.
 Ensure your procedure also covers methods to disallow unauthorized and
unapproved or incorrect documents from being created, used or distributed.
 If documents are to be archived make sure that all such documents are
properly identified, indexed and filed, and preferably have controlled or restricted access to
them. Again your procedure must cover how this is done.
 Clause 4.2.3.1 - Engineering Specifications – calls for a process.You must
therefore use clause 4.1a-f as guidance for documenting this process and include all the
TS16949 Page 33
controls required by this sub-clause. For all changes to these customer provided documents,
cross reference to PPAP documents such as Control Plans and FMEA’s. These documents
may need to be revised and may require PPAP re-approval. If in doubt, check your PPAP
reference manual or check specific customer requirements.
 Your process for engineering change control must also address any impact on
lower level documents such as production work instructions. Develop appropriate linkage
controls or checklist to ensure that such documents are appropriately updated. Also refer to
clause 7.1.4 Change control. We will cover this later when we get to that clause.
 Nonconformities against document control are one of the most frequent audit findings.
Develop appropriate performance indicators to demonstrate effective implementation of
your document control process. Examples include – number of obsolete or unauthorized
documents found being used; number of unauthorized changes found; number of instances
documents were not available at points of use; etc. Track trends in these indicators and use
this information to tighten your controls and continually improve your document control
process.
 As mentioned in clause 4.1, use the PDCA to plan, implement, measure and improve
your document control process. Your procedure should describe this approach.
TS16949 Page 34
4.2.4 Control of Records
16:52

4.2.4 Control of Records
Your organization shall:
Establish and maintain records as evidence that your QMS conforms to requirements and
that your QMS is being operated effectively.
Establish a documented procedure that controls how you identify; store; protect;
retrieve; retain and dispose of records.
Keep your records legible, readily identifiable, retrievable.
Note – disposition includes disposal; and records include customer-specified records
4.2.4.1 Record Retention

Control of records shall satisfy regulatory and customer requirements

 A record is a special type of document that provides written evidence of results
achieved or activity performed (e.g. an inspection record).
 Records provide one of the strongest forms of evidence of maintaining and
demonstrating the effectiveness of your QMS. Ensure that yourdocumented procedure for
control of QMS records addresses each of the control requirements specified in this clause,
in terms of who, what when, where and how. These controls apply to all QMS records
whether they are hardcopy or computerized.
 TS 16949 calls for many records. Some records are specified, while others are implied.
The onus is on you to demonstrate or provide evidence (records) of conformity to
requirements, whether the specific clauses ask for records or not. As we go through the
clauses, I will identify specific and implied records. Make a list for yourself as we go along.
 Besides, TS 16949, specific requirements for records may originate from the customer,
regulatory, industry, or within your organization. Ensure you maintain records to conform to
all of these as applicable. Records may also come from suppliers and outsourcers. All these
records are subject to the above controls. Review specific requirements at OEM customer or
IATF websites.
 The comments under document control regarding legibility, being identifiable and
retrievable apply equally to QMS records.
 Readily identifiable - relates to easily determining the purpose and scope of the
record, e.g. an inspection record for a product at final inspection. The design of QMS records
must prevent confusion or ambiguity in the completion and use of records. Records must be
writtenlegibly to be useful. Also make sure that they are not exposed to unauthorized
change or alteration.
 For the duration that they are kept, store records in locations and mediums that
will protect against unauthorized access and environmental damage - (covered in oil, dust,
acid eaten, weather-beaten, etc.). Regularly review the condition of records. The indexing
and filing of records (hardcopy or computer) must ensure easy retrieval.
 Keep a listing of all the different categories of records and define the retention times
associated with each category (inspection and test; sales and purchasing; management
TS16949 Page 35
review; calibration; training; etc). Retention times are typically determined by customer,
regulatory, industry or organizational requirements and policies. Check OEM websites for
retention times for specific QMS records.
 Records must eventually be disposed off once past their defined retention times.
Disposition could range from destruction of records to storing them in a secure onsite or off-
site archive. The intent here is to remove the risk of inadvertent use for current activities
and unauthorized access. Depending upon the industry, specific records may be kept
indefinitely.
 Nonconformities against the process control of records arise frequently. Develop
appropriate performance indicators to demonstrate effective implementation of your
record control process. Examples of indicators could include – number of instances of
inability to retrieve records; amount of time spent looking for records; number of instances
of incomplete records; number of instances of damaged records found; etc. Track trends in
these indicators and use this information to tighten your controls and continually improve
your record control process.
 As mentioned in clause 4.1, use the PDCA to plan, implement, measure and improve
your document control process. Your procedure should describe this approach.
TS16949 Page 36
5.1 Management Commitment
16:52

5. MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
Top management shall provide evidence of its commitment to develop and implement the
QMS and continually improve its effectiveness. To achieve this, they shall:
a) Communicate to the organization the importance of meeting requirements (customer,
statutory and regulatory)
b) Establish the quality policy
c) Ensure that quality objectives are established
d) Conduct management reviews
e) Ensure the availability of resources
5.1.1 Process Efficiency – Top management shall review the product realization &
support processes to assure their effectiveness and efficiency. Also see 7.5.1.4 & 8.2.1.1)

 Management commitment - relates to the responsibility of top management to provide
leadership and direction for quality management within the organization. They must
establish strategic quality management policies, directives and objectives consistent with
the purpose and capabilities of the organization. They must establish theorganizational
structure and internal environment that motivates personnel to achieve the organization's
quality management goals and objectives. They must provide adequate resources to
develop, implement, maintain and improve the QMS. They must periodically reviewQMS
performance to determine it suitability, adequacy and effectiveness.
 The above activities are all requirements of clause 5. Each sub-clause of clause 5 starts
with the phrase “top management”. Top management is now clearly accountable and
auditable for their role and responsibilities for the activities listed in the paragraph above.
 The phrase “provide evidence” is very important here. Evidence may include
documents and records showing top managements role in planning and implementing the
processes that apply clause 5 requirements.
 You must begin with identifying the processes within your organization that perform
these activities. These processes would typically include - business planning; quality
planning; management review; internal communication; organization structure; etc.
Business planning would address 5.1b and 5.1c; management review would address clause
5.6; and so on for the other sub-clauses. Top management would be the process owner of
all these processes.
 Clause 5.1a may be viewed in combination with clause 5.2 customer focus, and clause
5.5.3 internal communication. Top management must communicate regularly to the
organization on the importance of meeting customer and regulatory requirements. The
communication process should define what needs to be communicated; to whom; the
methods used; the frequency; and the means for determining communication effectiveness.
(See clause 4.1a- 4.1f for guidance in developing such a process.). Top management may
communicate in any number of ways including - meetings; documented policies; memos;
TS16949 Page 37
directives; email; verbally; etc.
 Clause 5.1 does not require a ‘documented’ procedure. However, you must identify and
document (e.g. process map; process flow diagram; etc.) the processes for business
planning; quality planning; management review; internal communication; organization
structure; etc. as part of your QMS (see clause 4.1). You must also identify what
specificdocuments are needed for effective planning, operation and control of these
processes (see clause 4.2.1d). These documents may include – a documented procedure;
business plan; statement of policies and objectives; etc.
 Top management at each site must review process efficiency. This may include:
 Achievement of continual improvement objectives for identifiedproduct realization and
support processes
 Optimization of the interaction of these processes
 Verification that these processes operate as an effective and efficient network
 Monitoring cost trends and benchmarking of key processes
 Note: effectiveness measures the extent to which planned activities (run
rate) and planned results (objectives) are achieved? E.g., say you plan to produce and ship
1000 units a day with zero defects. At the end of the week, the production records showed
we achieved our planned activity of 1000 units per day, but fell short on our planned result,
as we incurred a 2.5% defect rate and only hit a 90% on time delivery rate.
 Note: efficiency is the relationship between results achieved and resources used. Can
we produce more units than planned per hour for the set amount of resources? Or can we
use fewer resources than planned to produce the units.? Efficiency can relate to utilization of
any resource – machine, labor, material, facilities, utilities, time, etc.
 Let us look at a simple example. Say one operator A can produce 100 good units per
hour with 2% material scrap on a machine. Operator B produces 105 good units with only
1% material scrap per hour on the same machine. Clearly operator B is more efficient in the
use of time as well as material, both of which can be measured. Because there are many
other resources to be considered, the measurement of efficiency can get fairly complex and
requires a multidisciplinary approach involving production, engineering, cost accounting and
other disciplines.
 Where some of clause 5 activities are performed off-site (e.g. at head-office), you must
identify these off-site processes in your QMS and ensure that such processes comply with
TS 16949 requirements. Evidence of compliance may include - a copy of their TS 16949
certification; TS 16949 internal audit results (of these processes) for the off-site facility;
auditing these processes at the off-site facility. The expectation is to flow down to the off-
site facility, the relevant TS 16949 requirements that you would have to implement, had
you carried out the process at your own facility.
 The specific requirements for clause 5.1b through 5.1d will be discussed in the
upcoming sub-clauses.
TS16949 Page 38
5.2 Costumer Focus
16:53

5.2 Customer Focus
Top management shall ensure that:
Customer requirements are determined and met
Aim is to enhance customer satisfaction (also see clause 7.2.1 and 8.2.1)

 Organizations depend on their customers. Accordingly, you must understand current
and future needs of customers; develop customer focused processes; establish customer
goals and objectives; measure customer satisfaction against these goals and objectives;
have customer focused internal and external communications; and ensure that your
personnel are competent and trained in understanding and achieving customer
requirements.
 As this standard represents specific automotive OEM’s, your QMS must provide
objective evidence that your QMS processes can identify and manage these requirements
and that customer-specific requirements are effectively implemented. Review specific
requirements at OEM customer or IATF websites.
 You must communicate your OEM’s current and future product programs within your
own organization as well as flow them down the supply chain in terms of sub-products,
price, timing, delivery communication and support.
 You must have an effective communication process between your customer and your
organization, for discussion, review, timing, action and responsibility on the above issues.
 You must have an effective process for communication and review of the above
requirements to relevant personnel or departments within your own organization.
 It is top management role to provide the leadership and commitment of time and
resources to ensure this happens. Auditors will be looking for evidence of this.
 Clause 7.2.1 gets further into the details of understanding and processing customer
requirements. Clause 8.2.1 sets requirements for monitoring and measuring customer
satisfaction.
 Clause 5.2 provides the top management’s overall responsibility for customer
relationship management (CRM), while clause 7.2.1 provides the front end and clause 8.2.1
provides the back end, of the underlying and detailed activities of CRM.
 You will notice that customer focus can be included in the following processes –
business planning; communications; sales and marketing; and customer satisfaction
feedback.
document (e.g. process map; process flow diagram; etc.) the processes listed in the
paragraph above as part of your QMS (see clause 4.1). You must also identify what
specific documents are needed for effective planning, operation and control of these
processes (see clause 4.2.1d). Examples f such documents may include – a documented
procedure; business plan; statement of customer related policies and objectives; etc.
TS16949 Page 39
5.3 Quality Policy
16:53

5.3 Quality Policy
Top management shall ensure that the quality policy:
a) is appropriate to the purpose of the organization
b) includes a commitment to comply with requirements and continually improve the
effectiveness of the QMS
c) provides a framework to establish and review quality objectives
d) is communicated and understood within organization
e) is reviewed for continuing suitability

 Developing a QMS must be a strategic business decision and therefore top
management must provide the necessary direction and leadership, starting with establishing
the quality policy and objectives. Your quality policy provides top management’s vision on
quality management for the organization. It provides the organization with focused
direction, i.e. high level goals and objectives for quality management.
 Your quality policy must be consistent with the scope of your QMS (see clause 1-
scope) and other business, management and organizational strategies within the
organization. Aggressive sales or marketing strategies must not be at the expense of quality
management.
 Clause 4.1.a - requires that you document your quality policy and clause 5.3.c requires
that you specify your commitment to ‘meet requirements’and ‘continually improve the
effectiveness of your QMS’. Clause 1 specifies requirements for the scope of your QMS.
Paraphrasing the wording in clause 1 would be a good way to define your quality policy.
 The wording of the quality policy should preferably specify what requirements are being
complied with (customer, regulatory, TS 16949, etc.). It must also clearly state the
commitment to continually improve the effectiveness of the QMS.
 Beyond that, you may state other complementary and important policies (business
growth; product or manufacturing technology; workforce competence; business flexibility,
etc.)
 What you state in your quality policy, must lead to establishing quality objectives,
e.g. if you state in your quality policy that you will “meet customer requirements”, then
from this, you might derive customer focused objectives for – product defects; customer
complaints and returns; on time delivery, etc. Similarly, “meet TS 16949 requirements”;
from this you might derive process objectives for effectively and efficiently using TS
requirements to manage, control and improve al of your QMS processes.
 Stating that you will “continually improve the effectiveness of your QMS” in your
quality policy - can lead to a number of objectives, as your QMS is comprised of many
processes and you could have one or more objectives to improve each process.
 Therefore, each statement in your quality policy may result in one or more quality
objectives. These quality objectives do not need to be stated in your quality policy. Top
management must clearly be involved in providing direction, establishing and reviewing
TS16949 Page 40
these objectives.
 Earlier we had covered processes for internal and external communication. Your
internal communication process should cover how the quality policy is
communicated throughout the organization. There are many ways of doing this. Personnel
must understand the importance and impact of the quality policy on the work they do.
 If you recall from 4.2.1 your QMS includes documented statements of your quality
policy and quality objectives. Therefore, these documents must be controlled according to
clause 4.2.3 control of documents. Your quality policy and quality objectives may be
documented in your quality manual or as independent documents or both.
 If you recall from 4.2.1 your QMS includes the quality policy and quality objectives.
Therefore, these are controlled documents and must be controlled according to clause 4.2.3
control of documents.
 The quality policy is not written in stone. It must be reviewed periodically by top
management, for significant changes in your organization, e.g. management, ownership,
relocation, product, shift in customer base, etc. Such changes may result in changes to the
quality policy. The establishment of the quality policy should be part of the business
planning or QMS planning processes. A review of the quality policy for continuing
suitability should be part of your management review process (see clause 5.6).
 In clause 8.5.1, we will examine how the quality policy can be used as a tool for
continual improvement.
TS16949 Page 41
5.4.1 Quality Objectives
16:54
5.4 Planning
5.4.1 Quality Objectives

Top management shall:
Ensure quality objectives are established (including those needed to meet product
requirements (see 7.1a)
Set them at relevant functions and levels within the organization
Set measurable quality objectives
Keep these quality objectives consistent with the quality policy
5.4.1.1 Supplemental Objectives

Top management shall define quality objectives and measurements
These shall be included in the business plan and use to deploy quality policy. (See IATF
guidance)
Note : Quality objectives should address customer expectations and be achievable within a
defined time period

 Clause 4.1e requires you to plan quality objectives for QMS processes and clause 7.1
requires objectives for product. Clause 8.2.3 and 8.2.4 require you to monitor and measure
and evaluate results to your planned objectives. This clause 5.4.1 sets out specific
requirements for planning of quality objectives.
 Top management must provide the leadership, organization and resources to deploy
and achieve quality objectives.
 From the previous clause 5.3 we learned that the quality policy must provide the
framework for establishing quality objectives in order to be consistent with it and provided
examples of such consistency. In this clause, top management must ensure that
specific quality objectives are established.
 Use quality objectives to measure the performance of products; processes; customer
satisfaction; suppliers; use of resources; and the overall performance and effectiveness of
the QMS. Quality objectives may be established for all QMS processes.
 Examples of quality objectives:
 Product - reduction in defect rates, PPM’s (defective parts per million); improvement
in product life; durability; reliability; timing; cost; on time delivery; etc. (see clause 7.1a;
7.3.2.1). Also review specific PPM requirements at OEM customer or IATF websites.
 Cost of poor quality (internal and external) – reduction in - scrap; rework; disposal;
re-inspection; product recall; warranty; etc.
 Process – objectives generally focus on improving process productivity through the
elimination or reduction of variation and waste in process – inputs, outputs, conversion
activity and related use of resources. Objectives may be used to monitor and improve
TS16949 Page 42
process – productivity; reduction of cycle time, errors, omissions and failures; etc.
Examples could include objectives for - set-up time; run rates; process cycle time; scrap
rates; etc. (see clause 7.3.2.2; 7.5.1.4; 7.4.3.1).
 Customers - # of complaints; customer satisfaction rating; on time delivery; service;
support, etc, (see clause 8.2).
 Suppliers – material defects; on time delivery; # of complaints with supplier.
 Resources – (includes facility; equipment; labor; etc.) – objectives could be
established based on availability; capability; maintenance; personnel competency,
absenteeism; production rates; efficiency; safety; etc.
 For the QMS – customer satisfaction feedback; internal audit results; # of
improvement opportunities; etc.
 Remember the purpose of quality objectives is to determine conformity to
(customer and regulatory) requirements, and effective deployment and improvement of the
QMS
 Quality objectives may be set at various functional levels of the organization – top
management; departments; processes; functional groups; work cells; project teams;
individuals; etc. It would be useful to cover all these levels as all should add value and
contribute to customer or organizational objectives.
 Quality objectives must be measurable. Measurement can be done quantitatively or
qualitatively. Qualitative measures are generally more objective in determining whether
conformity or effectiveness has been achieved. In some situations, the use of qualitative
measurements may be appropriate. Objectives based on yes/no criteria, (e.g. – develop
new product by March 2006), are also acceptable.
 Clause 5.4.1.1 Supplemental - Under TS 16949, you must have abusiness
plan approved by top management that contains quality goals, objectives and
measurements for the organization, including those for quality. You must have
a process for creating, distributing and monitoring the quality objectives defined in the
business plan.
 These quality objectives must be deployed and measured (see clause 8) and top
management must conduct an effective review of themeasurement results. These
measurement results must also be used for corrective action and continual improvement.
 The quality objectives must be achieved within a defined time periodto ensure
accountability. This could be determined by your customer, your management, your head
office, regulatory bodies, etc. Your business plan must establish these time periods and your
business planning process must include the communication of objectives and timelines to
those responsible for achieving them.
 The establishment of quality objectives should be part of the business planning or QMS
planning processes. The output of business planning should be a Business Plan which must
include your quality objectives. A review of the quality objectives should be part of your
management review process (see clause 5.6). As a quality document, your business plan
must be controlled by 4.2.3 control of documents.
You have to be careful not to overwhelm your organization with too many objectives as this
may cause more frustration than positive results. Start with objectives that focus on
meeting customer requirements and then slowly develop meaningful objectives for key
processes and risk prone processes, as initial targets are achieved.
TS16949 Page 43
5.4.2 QMS Planning
16:54

5.4.2 Quality Management System Planning
a) Ensure QMS planning is carried out in order to meet clause 4.1 requirements as well as
quality objectives
b) Maintain the integrity of QMS when changes to system are planned and implemented

 It is the responsibility of top management to provide direction, resources and review
for QMS planning.
 When developing your QMS process controls (for determining customer requirements,
design, development, manufacture, delivery and customer support), you must focus on
meeting customer and regulatory requirements as well as the planned QMS objectives
established in clause 5.4.1.
 As I had mentioned earlier, clause 4.1 is the backbone of ISO 9001 as well as TS
16949. It provides direction on how to put together the framework of your QMS, i.e. your
QMS plan. The rest of the ISO and TS standard provide specific requirements for each of
the (customer, support and management) processes that make up your QMS.
 Your QMS planning as per 4.1 requires you to identify all your QMS processes and
describe each process and show their sequence and interaction with other processes. The
criteria and methods for controlling these processes come from the rest of the ISO/TS
requirements as well as your customer and your own organization. So if you have developed
your QMS following the steps explained under clause 4.1, you have addressed clause
5.4.2a.
 The continuity and effectiveness of your QMS must be substantially maintained in the
event of significant changes in your QMS or organization, e.g. management, ownership,
relocation, technology, product, shift in customer base, etc. Changes must be carefully
planned so as not to disrupt your organizations ongoing capability and responsibility to
effectively meet customer and regulatory requirements
 In such instances, change control would require:
 careful planning of the nature and timeline for the changes;
 determining the impact or outcome of such changes;
 ensuring adequate resources are available to implement the change;
 top management authorization
 change deployment and follow-up
 review of the QMS by top management after changes are effected.
 QMS planning could be a part of business planning or treated as an independent
process depending on organizational structure and responsibilities. The management
representative (see clause 5.5.2) typically facilitates QMS planning with the various process
owners. The process owners must take responsibility for implementation, maintenance and
improvement of their processes. The management representative may provide training and
technical assistance as needed. Top management through business planning must provide
TS16949 Page 44
leadership, resources and review of QMS performance.
 Performance indicators to demonstrate effective QMS planning could include –
achievement of quality objectives; improved customer satisfaction ratings; reduced number
and seriousness of internal/external audit nonconformities.
TS16949 Page 45
5.5.1 Responsibility & Athority
16:55

5.4.2 Quality Management System Planning
a) Ensure QMS planning is carried out in order to meet clause 4.1 requirements as well as
quality objectives
b) Maintain the integrity of QMS when changes to system are planned and implemented

 It is the responsibility of top management to provide direction, resources and review
for QMS planning.
 When developing your QMS process controls (for determining customer requirements,
design, development, manufacture, delivery and customer support), you must focus on
meeting customer and regulatory requirements as well as the planned QMS objectives
established in clause 5.4.1.
 As I had mentioned earlier, clause 4.1 is the backbone of ISO 9001 as well as TS
16949. It provides direction on how to put together the framework of your QMS, i.e. your
QMS plan. The rest of the ISO and TS standard provide specific requirements for each of
the (customer, support and management) processes that make up your QMS.
 Your QMS planning as per 4.1 requires you to identify all your QMS processes and
describe each process and show their sequence and interaction with other processes. The
criteria and methods for controlling these processes come from the rest of the ISO/TS
requirements as well as your customer and your own organization. So if you have developed
your QMS following the steps explained under clause 4.1, you have addressed clause
5.4.2a.
 The continuity and effectiveness of your QMS must be substantially maintained in the
event of significant changes in your QMS or organization, e.g. management, ownership,
relocation, technology, product, shift in customer base, etc. Changes must be carefully
planned so as not to disrupt your organizations ongoing capability and responsibility to
effectively meet customer and regulatory requirements
 In such instances, change control would require:
 careful planning of the nature and timeline for the changes;
 determining the impact or outcome of such changes;
 ensuring adequate resources are available to implement the change;
 top management authorization
 change deployment and follow-up
 review of the QMS by top management after changes are effected.
 QMS planning could be a part of business planning or treated as an independent
process depending on organizational structure and responsibilities. The management
representative (see clause 5.5.2) typically facilitates QMS planning with the various process
owners. The process owners must take responsibility for implementation, maintenance and
improvement of their processes. The management representative may provide training and
technical assistance as needed. Top management through business planning must provide
TS16949 Page 46
leadership, resources and review of QMS performance.
 Performance indicators to demonstrate effective QMS planning could include –
achievement of quality objectives; improved customer satisfaction ratings; reduced number
and seriousness of internal/external audit nonconformities.
TS16949 Page 47
5.5.2 Management Representative
16:55

5.5.2 Management Representative
Top management must:
Appoint a member of management as the Management Representative (MR)
Irrespective of other responsibilities, the MR shall have the responsibility and authority to:
a) ensure processes needed for the QMS are established, implemented, and maintained
b) report to top management on QMS performance and any need for improvement to it
c) ensure the promotion of awareness of customer requirements throughout the
organization
(Note: The MR’s responsibilities may include liaison with external parties on matters relating
to the QMS)
5.5.2.1 Customer Representative – top management shall designate personnel with

responsibility & authority to ensure that customer quality requirements are addressed. This
includes –
 special characteristics;
 setting quality objectives and related training;
 corrective and preventive action
 product design and development.

 The rationale for appointing a member of management as the MR is so the individual
has sufficient authority to effectively carry out QMS responsibilities. The individual should
preferably be a member of top management, but not necessarily so. The MR’s role is to
facilitate, motivate and promote the deployment of QMS requirements throughout the
organization, through guidance, training, teamwork and assistance.
 In carrying out QMS responsibilities, the MR may need to communicate, delegate,
empower, report, oversee and interact with individuals at all levels internal and external.
 “Irrespective of other responsibilities ” means that the MR may wear other hats
and the MR hat does not have to be the primary one. Regardless, once appointed as the MR,
the individual must effectively perform all QMS responsibilities specified in this sub-
clause. Much of this can be done through having access to appropriate resources and
through delegation. The MR may be a full-time or sub-contracted person.
 Top management may show evidence of the appointment of the MR through an
appointment posting; attendance at QMS review meetings; provision of support,
authorization and resources to QMS activities.
 Since quality is the responsibility of the entire organization, the role of the MR is to
assist process owners in developing their processes according to the requirements of clause
4.1 and applying the requirements of other specific clauses of ISO 9001 relevant to their
process. For example the purchasing, production or warehousing processes must also know
how to control nonconforming product (clause 8.3); take corrective action (clause 8.5.2) or
control their records (clause 4.2.4); etc.
 Reporting to top management on QMS performance may take place at
TS16949 Page 48
management review meetings or other meetings. The information for the report will come
from the results of the measurement and monitoring requirements specified in clause 8
(e.g. internal audits and customer satisfaction feedback, etc.). The MR must delegate and
facilitate the compilation of this information from all the process owners.
 The report must include any recommendation to improve the QMSbased on the
MR’s review of all QMS measurement and monitoring data. It would be appropriate to
discuss and obtain agreement with affected process owners.
 As we discussed earlier, TS 16949 focuses heavily on meeting customer and
regulatory requirements and enhancing customer satisfaction. The MR must
likewise promote this focus through all processes that are directly and even indirectly
involved in achieving this. There are many ways of doing this including the use of training;
cross-functional teams; customer focused project teams; project milestone reviews;
designated customer representative; electronic interfaces with the customer; use of PPAP,
FMEA’s, Control Plans, customer specifications, customer product specific work instructions,
etc.
 The appointment of the MR and defining his/her responsibilities ands authority should
be part of the business planning process. The MR’s activities must be included in quality
planning; management review and communication processes.
 The designated customer representative(s) and their specific responsibilities must
be clearly defined. They must ensure that customer requirements are fully understood and
addressed. A good way to address this, is for the customer representative to participate in
the entire APQP (Advanced Product Quality Planning) process (see reference
manual).Review specific requirements for the customer representative at OEM customer or
IATF websites.
 The effective fulfillment of the customer representative’s responsibilities may be
demonstrated by their participation in milestone and decision points related to production
release; engineering release and other related activities linked to customer requirements.
 Overall QMS performance indicators may be used to determine how well the MR has
performed the responsibilities defined in clause 5.5.2.
TS16949 Page 49
5.5.3 Internal Communications
16:56
5.5.3 Internal Communications

Top management shall ensure that:
Appropriate communication processes are established within the organization
Communications take place regarding the effectiveness of QMS

 Communications is a complex and difficult activity. Problems may arise due to
incomplete, ambiguous or inaccurate information being transmitted; transmission to the
wrong person, too late or at the wrong time; use of inappropriate or unreliable media, etc.
Communication problems are probably the most common cause of QMS
nonconformities. Tracking some of the more serious communication issues could serve as
useful performance indicators to determine and improve communication process
effectiveness.
 Clause 4.1 control of processes- requires you to determine the sequence and
interaction of QMS processes. Each process requires inputs to flow from one process and
outputs to flow to another process. There is a continuous (communication) flow regarding
tangible (materials and product) and intangible (information) inputs and outputs taking
place within your organization.
 Communication and interaction between QMS processes takes place at all levels of the
organization. Top management must plan for internal and external communication methods
and resources at the high level using the business planning process and deploy these
methods through the information technology; logistic and HR processes.
 At the operations level, each process owner must identify the methods of
communication (computer; documents; telephone; meetings; directives, visual, etc,) used
and determine whether these methods are appropriate – are they effective for the purpose
intended? - (do they prevent non-conformities from arising due to the reasons mentioned
above?). Process owners should provide feedback on communications effectiveness to the
processes providing and controlling such resources, e.g. IT and top management (business
planning).
 The MR must communicate on QMS effectiveness not only to top management (see
clause 5.5.2b, but also to appropriate levels within the organization. If everyone is
responsible for quality, then all process owners as well as their personnel are entitled to
receive periodic feedback on their areas of responsibility.
 Selected (non-confidential) operational performance data as well as QMS data (see

clause 8) may be communicated through various means. The focus of this reporting must be
on the effectiveness of the organization and the QMS in meeting customer and regulatory
requirements.
 TS 16949 clauses that specify communication requirements include- 4.1.d; 5.1.a;
5.3.d; 5.5.1; 5.5.2.b; etc.
 The effective planning, operation and control of internal communication processes may
be demonstrated through the performance indicators described in the first paragraph of this
section above. Documentation of control methods could include technical manuals; training
TS16949 Page 50
provided; signage; computer system; etc.
 The performance indicators for the business planning; HR process and QMS processes
may be used to determine the effectiveness of planning and managing the organizational
structure, responsibilities and authorities.
TS16949 Page 51
5.6 Management Review
16:56
5.6 Management Review
5.6.1 General
Top Management shall:
Perform reviews of the QMS
Conduct these reviews at planned intervals
Ensure that the QMS continues to be suitable, adequate and effective
Assess opportunities to improve the QMS
Evaluate the need for any changes to QMS, quality policy and objectives
Maintain records of management reviews
5.6.1.1 QMS performance – these reviews shall include:

All requirements of the QMS & its performance trends as an essential part of the continual
improvement process
Monitoring of quality objectives (see 8.4.1)
Regular reporting and evaluation of cost of poor quality (see 8.5.1)
The above review shall be recorded and provide, as a minimum, evidence of the
achievement of;
Quality objectives specified in the business plan
Customer satisfaction with product supplied
5.6.2 Review Input

Management review input shall include information on:
a) Results of audits
b) Customer feedback
c) Process performance and product conformity
d) Status of preventive and corrective actions
e) Follow-up actions from previous mgmt reviews
f) Changes that could affect the QMS
g) Recommendations for improvements
5.6.2.1 Review input - Supplemental

Shall include an analysis of actual & potential field failures and their impact on quality,
safety or the environment.
5.6.3 Review Output

The output from management review shall include any decisions and actions related to:
a) Improvement of effectiveness of the QMS and its processes
TS16949 Page 52
b) Improvement of product related to customer requirements
c) Resource needs

 The purpose of conducting management reviews of the QMS is to gauge the health of
the QMS. The review must determine QMS suitability, adequacy and effectiveness. Are the
QMS resources and controls that were planned and implemented, suitable and adequate for
the QMS to be effective in achieving customer and regulatory requirements; and in
achieving quality objectives? Are changes needed to improve product, processes and use of
resources?
 A process to administer Clause 5.6 would be appropriate as it has ISO 9001 standard
specifies requirements for management review inputs, value-adding review activities and
outputs. The process must address the frequency, schedule, quorum and agenda for review
meetings to be attended by top management. Review specific requirements for
management review at OEM customer or IATF websites.
 For the management review process itself to be effective, top management
must plan the review of all agenda items with some regularity to gauge the health of the
QMS and take timely action to change or improve any part of it, including the quality policy
and objectives. To avoid problems on frequency and scope of review, an effective way
would be incorporate QMS agenda items into regular monthly or quarterly operational
meetings. Some OEM’s require management review to be held not less than once a year.
 Clause 8 provides the majority of the agenda information for management review. In
addition to the items listed in 5.6.2; 5.6.1.1; 5.6.2.1, management review must also
include – 7.3.4.1 summary of design and development measurements; 5.1.1 process
efficiency.
 Under clause 5.6.1.1, all requirements of the QMS must be reviewed. The review of
QMS deployment and performance might be measured through gap analysis for new
systems and the results of internal audits for established systems. Management review
must include the results of such analysis and audits.
 The agenda items in clause 5.6.2 will be discussed in detail under various other TS
16949 clauses as they come up. For example most of clause 5.6.2 agenda items come up in
clause 8. Field failures (clause 5.6.2.1) will be discussed under clause 7.5.1.7.
 QMS objectives must flow from the business plan. The costs of internal and external
poor quality as well as process metrics for all processes defined in clause 4.1.must be
measured and evaluated against business plan objectives and customer satisfaction goals.
 Management review input should preferably be in summary form, showing QMS and
operational performance measured against the business and quality plans, customer and
regulatory objectives and goals. Appropriate actions must result from such reviews.
 Review decisions and actions must relate to improving products and processes or even
creating new ones; providing more resources or perhaps improving the efficiency of existing
resources; improving QMS controls; policies and objectives; and improving overall QMS
effectiveness and customer satisfaction.
 Responsibilities and timelines should accompany these decisions and actions. The
performance of these actions must be followed up at subsequent management review
meetings.
 Performance indicators to measure the effectiveness of the management review
process could include - achievement of quality objectives and improvement in customer
satisfaction rating (see QMS objectives under clause 5.4.1 notes).
document the management review process as part of your QMS (see clause 4.1). You must
TS16949 Page 53
also identify what specificdocuments are needed for effective planning, operation and
control of this process (see clause 4.2.1d). These documents may include – a documented
procedure; review schedule; agenda and action forms; etc., combined with unwritten
practices, procedures and methods.
 Management review records must include topics discussed; decisions; responsibilities
for corrective or improvement actions and related timelines; provision of resources; and
follow-up actions from previous management reviews.
TS16949 Page 54
6.1 Provision of Resources
16:57

6.1 Provision of Resources
Your organization shall determine and provide the needed resources to:
Implement and maintain the QMS & continually improve its effectiveness
Enhance customer satisfaction by meeting their requirements

 In clause 5.1e we saw that top management has the responsibility to ensure the
availability of resources to develop and maintain your QMS.
 Clause 6.1 requires you to determine the nature and availability of such resources. This
is typically done through business and quality planning.
 Use business planning (clause 5.1); quality management planning (clause 5.4) and
planning for QMS processes (clause 4.1), to identify and determine the nature of resource
needs of QMS each process and plan for its availability. The actual amount of resources
needed may vary day to day and over time. This is one reason why top management must
review QMS performance (see clause 5.6.2) regularly.
 Having adequate resources is vital (as many organizations run into QMS
nonconformities as a result of insufficient or improper use of resources) to ensure product
conformity or satisfy customer requirements – e.g. having adequate personnel, materials
and equipment to ensure timely production and delivery of product. Review specific
requirements for provision of resources at OEM customer or IATF websites.
 Consider developing performance indicators for each major category of resources used,
(e.g. machinery and equipment; human resources; facility and environment; transport;
communication systems; etc.) to determine the effective use of such resources.
 Where the resource planning process is performed off-site (e.g. at head-office), your
QMS must include the off-site processes within your QMS and ensure that such processes
comply with TS 16949 requirements. Evidence of the off-site facility’s compliance may
include - a copy of their TS 16949 certification; results of their internal audits to TS 16949;
auditing the outsourced facility; etc. The expectation is to flow down to the off-site facility,
the relevant TS 16949 requirements that you would have to implement, had you carried out
the process at your own facility.
TS16949 Page 55
6.2 Human Resources
16:58

6.2 Human Resources (HR)
6.2.1 General
Personnel performing work affecting product quality shall be competent on basis of
appropriate education, training, skills and experience
6.2.2 Competence, Awareness and Training

a) Determine the necessary competence for personnel performing work affecting product
quality
b) Provide training (or take other actions) to satisfy these competency needs
c) Evaluate the effectiveness of the actions taken
d) Ensure employees are aware of the relevance & importance of their activities & how
they contribute to achieving quality objectives
e) Maintain appropriate records of education, training, skills, and experience
6.2.2.1 Product Design Skills

Design and development personnel with product design responsibility shall be competent to
achieve design requirements and are skilled in applicable tools & techniques.
Your organization shall identify these tools and techniques.
6.2.2.2 Training
You shall establish and maintain documented procedures for identifying training needs
and achieving competence of all personnel performing work affecting product quality.
Personnel performing specific assigned tasks shall be qualified and focused on satisfying
Note 1 This applies to employees at all levels of the organization having an effect on
quality.
Note 2 An example of customer specific requirements is the application of digitized
mathematically based data.
6.2.2.3 Training on the job

You shall provide on the job training for personnel in any new or modified job.
You shall provide on the job training for contract or agency personnel.
Inform personnel whose work can affect quality, the consequences to the customer of
nonconformity to quality requirements
6.2.2.4 Motivation & empowerment – your organization shall haveprocesses that:

Motivate employees to achieve quality objectives
Make continual improvements
TS16949 Page 56
Create an environment that promotes innovation
Promote quality & technological awareness throughout the whole organization
Measure the extent to which its personnel are aware of the relevance and importance of
their work and their contribution to achieving quality objectives (see 6.2.2.d)

 You will recall under clause 5.1e top management is responsible for ensuring the
availability of resources which includes HR. Clause 5.5.1 requires top management to define
the organization and its responsibilities and authorities. Clause 6.1 required that adequate
resources (e.g. HR) be determined and provided. And here in clause 6.2 the specific
requirements for controlling HR are defined.
 Planning for HR process controls requires having a documented procedure that
defines or references - competency criteria; skills evaluation; identification of training
needs; types of training; provision of training; how training effectiveness is evaluated;
methods to communicate awareness of the importance of quality requirements and meeting
quality objectives, to all employees.
 Criteria for competency must be developed based on appropriate education, skills,
training and experience for activities, tasks, functions and processes. The level and detail of
such qualifications will depend upon the complexity of product, process, technology and
customer and regulatory requirements.
 It is up to your organization to determine the necessary criteria for the various
functions and activities affecting product and QMS. A “Skills Matrix” is a useful tool used by
organizations to determine and manage the competency levels required by different
activities and functions.
 The competency criteria for personnel with responsibility for design and
development must be defined as well as the specific tools and techniques they need to
use. These may include – computer-aided design (CAD); design for manufacturing (DFM);
design for assembly (DFA); design of experiments (DOE); etc. For a full list of these tools,
refer to the IATF TS 16949:2002 guidance document.
 Organizations undergo significant changes through growth or decline, acquisitions, new
technology and new products and processes, Also, many organizations are now outsourcing
their production labor to save on payroll costs and benefits. Labor related nonconformities
can easily arise in such cases. Planning for your HR process must ensure that contract and
agency personnel performing work affecting product quality have adequate competency and
training. Appropriate records must be kept of such training.
 You must determine the scope and duration for effective on the job training for
product related work. This training must be provided to all full-time as well as contract and
agency personnel performing such work. They must also be informed of what
nonconformities may arise and the consequence to the (internal and external) customer.
Appropriate records must be kept of such training as well as training effectiveness. Review
specific requirements for training at OEM customer or IATF websites.
 Quality awareness must be focused on meeting customer and regulatory
requirements . The process to measure employee awareness of the importance of their
work in meeting customer requirements and quality objectives may include the use of –
department or process quality metrics; involvement in quality planning; ongoing training
programs; zero defect programs; product workshops; use of cross-functional teams; etc.
 QMS personnel must be motivated to achieve the organizations quality objective.
The process to motivate employees and promote quality awareness and innovation may
include the use of – cross-functional teams; employee surveys; employee recognition
awards; improvement suggestions; poster campaigns; quality circles; workshops; etc.
 You must determine and keep appropriate records of education; training; skills and
TS16949 Page 57
experience. These records must demonstrate the effective operation of HR process controls
(see first sentence of clause 4.2.4 quality records).
 Performance indicators to measure the effectiveness of the HR process in determining
competency and training needs of the workforce, could include – employee turnover;
employee complaints; number of instances unqualified personnel were found performing
QMS activity; number of instances competency criteria were not met; and number of
instances no training or competency records maintained; etc.
TS16949 Page 58
6.3 & 6.4 Infraestructure & Work Environment
16:58
6.3 Infrastructure
Your organization shall determine, provide and maintain the infrastructure needed to
achieve conformity to product requirements. Infrastructure includes, as applicable:
a) Buildings, workspace and associated utilities
b) Process equipment (hardware and software)
c) Supporting services (such as transport or communication)
6.3.1 Plant, facility & equipment planning

Your organization shall use a multi-disciplinary approach to plan:
Plant layouts that optimize material travel & handling
Facilitate synchronous material flow
Optimize value added use of floor space
Develop methods to evaluate and monitor effectiveness of existing operations
Note: Focus on lean manufacturing principles & link to QMS effectiveness
6.3.2 Contingency plans

Have contingency plans to satisfy customer requirements for - emergencies such as utility
interruptions, labor shortages, key equipment failure and field returns.
6.4 Work Environment

Determine and manage the work environment needed to achieve conformity to product
requirements
6.4.1 Personal safety

Minimize potential risks to employees & achieve product safety through controls in the D&D
and mfg processes
6.4.2 Premise Cleanliness

Keep premises in adequate state of order, cleanliness and repair consistent with product &
mfg process needs

 Planning for the types of infrastructure resources needed for your business may
include – facility; production equipment; IT equipment and software; laboratory; packaging;
dies; molds; tooling; jigs; fixtures; storage; transportation; communication; office;
materials; labor; utilities and supplies, etc.
 The key strategic business factors to be considered
for infrastructureplanning include: future needs; current availability and capacity;
cushion for growth; contingency planning; linkage to current and future product programs.
This planning may be done through business planning (clause 5.1); quality management
planning (5.4) and planning for QMS processes Clause 4.1). The actual deployment of such
resources may be determined by each process owner.
 You must have a facilities plan for developing your infrastructure. This plan must
TS16949 Page 59
address – plant layout; optimization of material travel and value-added use of floor space;
synchronous material flow; waste reduction and lean manufacturing; facility and equipment
maintenance; equipment capability and consistency; control of the work environment;
employee and product safety; facility day to day housekeeping; and contingency
planning. . Review specific requirements for facility planning at OEM customer or IATF
websites.
 The productivity and effectiveness of existing operations must be evaluated
through consideration of – ergonomic and human factors; operator and line balance;
storage and buffer inventory levels; use of automation; value added content and use of a
work plan.
 You are required to maintain your infrastructure. Your planned preventive maintenance
program should include controls for – schedule and timing; availability and training of
personnel; types and scope of maintenance; maintenance and competency/training records;
tracking to maintenance objectives; use, storage and control of spare parts; control of any
maintenance outsourcing; etc. There are many software programs available to help do this.
Also see notes under clause 7.5.1.4.
 You must have contingency plans that includes – availability of alternate remote
production sites for multi-site situations; appointment of a responsible person to operate
emergency procedures; key equipment/machinery list; maintenance operation records; and
outputs of a risk analysis result (similar to a product or process FMEA, but on a more
global – business and infrastructure scope). . Review specific requirements for contingency
planning at OEM customer or IATF websites.
 Work environment include controls for ergonomics; personnel safety and facility
conditions that are conducive to achieving product quality. Some of the factors to consider
in determining and managingergonomics include - (worker movement; fatigue; manual
effort and loads, etc); workplace location; social interaction; heat; light; humidity; airflow;
noise; vibration; etc). The applicability and degree to which applicable of these factors will
vary from facility to facility. The focus should be employee safety, welfare and product
conformity. Review specific requirements at OEM customer or IATF websites.
 Personnel safety – factors to consider may include – defined responsibility for safety;
error-proofing in DFMEA and PFMEA; knowledge and application of regulations; lessons
learned from internal/external audits and corrective actions; records of accidents; workplace
risk analysis; safety procedures; and use of safety equipment.
 Facility conditions include - cleanliness of premises. Factors to consider may
include – defined responsibilities for order and cleanliness; appropriate disposal conditions;
appropriate space and storage conditions; clean intact transport and operating equipment;
organized, clean and well lit workplaces and inspection stations; hygiene standards;
availability of facilities for lockers; lunchroom; cafeteria; washrooms; etc. . Review specific
requirements for cleanliness at OEM customer or IATF websites.
 Performance indicators to measure the effectiveness of processes (see first paragraph
above) that determine and control the effective use of infrastructure may include –
equipment maintenance - uptime/downtime; productivity – equipment and workforce;
accident and safety incidents; non-value added use of floor space; excessive handling and
storage; number of instances specific resources were not available or delayed; etc.
TS16949 Page 60
7.1 Planning of Product Realization
16:59
7 PRODUCT REALIZATION
7.1 Planning of Product Realization

Your organization shall plan and develop the processes needed for product realization
This planning shall be consistent with the requirements of other processes of your QMS (see
4.1)
In planning product realization, you organization shall determine, as appropriate:
a) Product quality objectives and product requirements
b) The processes, documents and resources specific to the product
c) Specific product verification, validation, monitoring, inspection, and test activities; and
criteria for product acceptance
d) Records needed as evidence that realization processes and resultingproduct meet
requirements (see 4.2.4)
Keep such planning output in a form suitable to your organization’s method of operations
Note 1: A quality plan is a document that specifies the QMS processes
(including product realization processes) and resources applied to a specific product,
project, or contract.
Note 2: An organization may also apply the requirements of 7.3 to the development of
the product realization processes
Note: You may use project management or APQP to achieve productrealization.
Advanced Product Quality Planning (APQP) focuses on error prevention and continual
improvement (as contrasted with error detection) and uses a multidisciplinary approach.
7.1.1 Product Realization Planning - Supplemental

Your Quality Plan shall include customer requirements & references to their technical
specifications.
7.1.2 Acceptance Criteria

Define acceptance criteria & get customer approval where required. For attribute data
sampling, the acceptable level shall be zero defects (see clause 8.2.3.1).
7.1.3 Confidentiality
Keep confidential - customer contracted products and projects under development and
related product information
7.1.4 Change Control

Have a process to control & react to changes from internal, customer or supplier sources,
that impact product realization. Your controls shall:
Assess the changes and their effects.
Define verification and validation activities (for these changes) to ensure compliance with
TS16949 Page 61
Validate changes before implementation.
Review with your customer, any changes to propriety designs, impact on fit, form and
function, to ensure that all effects are evaluated
Perform any additional verification/ identification, when required by the customer, e.g.
new product introduction
Note 1 : Notify & get approval from your customer, for any productrealization change
affecting customer requirements.
Note 2 : This clause for change control applies to changes to product as well as
manufacturing processes.

 Clause 7.1 is essentially a repeat of clause 4.1, but applied specifically
to product realization processes (see clause 4.1 explanation points – COP’s). The focus is
on controls governing the making of product to meet customer requirements and all the
QMS processes that, directly or indirectly, make this happen. Review specific product
realization requirements at OEM customer or IATF websites.
 Product realization processes may include – customer related processes (sales and
marketing); design and development; production; shipping; receiving; packaging;
measurement and monitoring of product and processes, customer satisfaction feedback;
etc., whether performed onsite or off-site.
 Some of the support processes that apply to product realization processes include -
document control; record control; human resources; infrastructure provision and
maintenance; IT; purchasing and materials management; laboratory services; and control
of monitoring and measuring devices, etc.
 You must show the sequence and interaction of these processes. The APQP is an
excellent tool to accomplish this. Using the APQP methodology, your organization can
identify the processes and controls needed to plan product realization from – identification
and understanding of customer requirements; product design and development if
applicable; manufacturing design and development; manufacturing and delivery. The focus
of APQP is defect prevention and continual improvement, as well show how the processes
link and interact with one another.
 The notes to 7.1 also permit you to use other project management tools or clause 7.3
requirements to develop product realization processes. You may need to consult your
customer to confirm such alternate methods.
 The Quality Plan (Control Plan) is the output of the APQP process and is used to deploy
product realization. The Control Plan must include product details and control
characteristics; process sequence and process control parameters; specific resources
needed to make, verify and deliver product; product and process monitoring and
measurement controls; plans to control and correct any product or process
nonconformities. reference to support processes; documents needed (such as work
instructions or engineering specifications, etc.) and details of records to be kept;
 Focus on defect prevention in planning the controls for product realization
 Quality objectives; product requirements as well as product realization process
requirements may come from the customer, your own organization, regulatory bodies and
industry standards or codes.
 Quality objectives may include – defect rates; PPM’s; scrap rates, etc. Requirements or
criteria for the product may include – physical; dimensional; functional, etc, and their
related measurements, tolerances and acceptance levels. In many instances, depending on
the nature of the product, the customer may specify objectives and requirements /criteria
for the product realization processes as well. Obtain customer clarification and approval
TS16949 Page 62
where required.
 Many customer requirements may come from the sources and reference documents I
listed on page 1 of this document. You must pay careful attention to this listing as they may
be as applicable as customer contracts and product specifications.
 Required verification, validation, monitoring, inspection and test activities must apply
to all processes identified for product realization and must be defined in your FMEA’s,
Control Plan, work instructions, and other documents used for product realization.
 Access to storage of confidential documents and data (electronic or hard copy) should
be controlled. Be extra careful of confidentiality requirements relating to new projects and
changes. Obtain clarification and approval from your customer when outsourcing production
or needing to disclose technical information when sourcing materials.
 Change control is a very important part of the product realization process. It applies
to ANY change in product realization and includes product and manufacturing process
changes. Uncontrolled changes lead to both customer and internal quality problems. The
defined process must include authority for change and consistency of implementation and
communication.
 For effective change control, follow the applicable requirements of the APQP
methodology for assessing, verifying and validating product realization changes before
implementing. Comply with any customer requirements for notification and approval of
changes.
 Your change control process must include – responsibility; evaluation; verification and
validation; frequency; timing; method; communication; training; documentation; update of
affected activities and documents; implementation; use of multi-disciplinary approach;
checklists; etc., for product realization changes.
 Changes may arise from customer complaints; feedback from the field; new
technology; supplier and material changes; internal or customer driven changes; process
improvements; SPC data; etc.
 Product realization changes may affect several linked activities and documents. Such
as – clauses (4.2.3.1; 7.3.6.3; 7.3.2.3; 7.3.3.1; 7.3.3.2; 7.3.6.2; 7.5.1.1 and 7.5.1.2).
These cover customer engineering specifications; FMEA’s (design and process); Control
Plans; design record; inspection instructions; machine process parameters; material
specifications; measuring equipment; part approval requirements; technical drawings; and
work instructions.
 Where any of the product realization processes are done off-site (e.g. at head-office),
your QMS must include the off-site processes within your QMS and ensure that such
processes comply with TS 16949 requirements. Evidence of the off-site facility’s compliance
may include - a copy of their TS 16949 certification; results of their internal audits to TS
16949; auditing the outsourced facility; etc. The expectation is to flow down to the off-site
facility, the relevant TS 16949 requirements that you would have to implement, had you
carried out the process at your own facility.
 Performance indicators, (to measure the effectiveness of product realization in meeting
requirements and achieving quality objectives,) will be specific to each realization process
and focus on reducing variation and waste in realization processes and related use of
resources. Objectives may be used to monitor and improve process – productivity;
reduction of cycle time, errors, omissions and failures; etc.
 You must also consider indicators to measure product performance such as - reduction
in defect rates, PPM’s (defective parts per million), scrap rates, waste and rework;
improvement in on time delivery (see clause 7.1a); product returns from customer; etc.
TS16949 Page 63
7.2 Costumer Related Processes
16:59
7.2 Customer-related Processes
7.2.1 Determination of Requirements Related to the Product

You shall determine the requirements related to the product:
a) Specified by your customer (including delivery and post-delivery activities)
b) Not stated by your customer (but needed for specified or intended use, where known)
c) Statutory and regulatory requirements related to the product
d) Any additional requirements determined by your organization
Note 1: Post delivery activities include after-sales product service, provided as part
of customer contract or order
Note 2 : This requirement includes recycling, environmental impact & characteristics
identified as a result of knowledge of product & manufacturing processes (see clause
7.3.2.3)
Note 3 : Compliance to (c) includes all applicable government, safety & environmental
regulations applied to acquisition storage, handling, recycling, elimination & disposal of
materials
7.2.1.1 Customer – designated Special Characteristics

You shall demonstrate conformity to customer requirements for designation, documentation
and control of special characteristics.
7.2.2 Review of Requirements related to the Product

You shall conduct a review of requirements related to the product beforecommitting to
supply product to the customer (e.g. submission of tenders; acceptance of contracts or
orders; acceptance of changes to contracts or orders) and to ensure that:
a) requirements relating to the product are defined
b) contracts or order requirements differing from those previously expressed are resolved
c) your organization has the ability to meet defined requirements
You shall maintain records of this review of requirements and actions arising from this
review
You shall confirm customer requirements before acceptance, where the customer provides
no documented statement of requirement.
You shall ensure that relevant documents are changed and relevant personnel are informed
of the changes, when product requirements are changed.
Note In some situations, such as internet sales, a formal review is impractical for each
order, instead the review can cover relevant product information such as catalogues or
advertising material.
7.2.2.1 Review of requirements relating to the product - Supplemental

You shall obtain customer authorization, if you plan on waiving the requirement stated in
TS16949 Page 64
7.2.2 for a formal review (see Note).
7.2.2.2 Organization Manufacturing Feasibility

As part of the contract review process, you shall investigate, confirm and document the
manufacturing feasibility of the proposed products as well as perform a risk analysis,
7.2.3 Customer Communication

You shall determine and implement effective arrangements for communicating with
customers on:
a) Product information
b) Enquiries, contracts, or order handling (including amendments)
c) Customer feedback (including complaints)
7.2.3.1 Communication Supplemental –

You shall have the ability to communicate necessary information, including data, in a
customer specified language & format (e.g. computer aided design data, electronic data
exchange).

 Customer related processes must include controls for - determining customer and
regulatory requirements; a review of such requirements; and communication with the
customer.
 Customer requirements extend beyond product specifications and may include – on-
time delivery; packaging; labeling, mode of delivery, documentation, communications, QMS
requirements, after sales servicing, etc. Review customer specific requirements on IAOB
websites; IATF requirements; design specifications and design records, etc. Many of these
requirements may also come from regulatory, industry or from within your own
organization.
 As this standard represents specific automotive OEM’s, your QMS must provide
objective evidence that your QMS processes can identify and manage these requirements
and that customer-specific requirements are effectively implemented. Priority should be
given to customer-specific requirements issued by IATF subscribing OEM members (e.g. GM,
Ford, Daimler-Chrysler, BMW, Fiat, Renault, VW, etc.) These requirements may be obtained
through OEM contracts, service level agreements, SQA procedures, OEM websites, etc. Also
review specific requirements for product at OEM customer or IATF websites.
 Depending on the product or service, you must determine if any industry or regulatory
requirement is applicable on product characteristics or process parameters that affect the
product’s safety or compliance with regulatory requirements. Determine if there are any
designated special characteristics related to products or process. You must consider all laws
and regulatory requirements that may affect your product, materials, labor, production
processes, your facility and work environment, etc.Review specific requirements for special
characteristics at OEM customer or IATF websites.
 Where some or all of the processes - for determining customer requirements; for
contract review and customer communication; etc., are done offsite, then you must show
the linkages and interaction of these offsite activities with your on-site QMS processes (see
clause 4.1).
 Where the organization, product and processes are complex and may require a
multidisciplinary approach. The APQP process is a good tool to control and manage this
process.
 The nature of requirements review may be different for different types of product or
services. Your review records must show basis of review.
TS16949 Page 65
 Make sure you do your due diligence, Feasibility and risk analysis before you commit to
contractual arrangements. I have seen many tier 1 and 11 suppliers get into serious
financial trouble, for taking on programs and product that the OEM transferred from another
supplier, because they did not assess all the risks. Be careful of taking on other suppliers
problems!
 Manufacturing feasibility (which includes risk analysis), is an assessment of your
organization’s capacity and capability to effectively and efficiently provide the customer
specified deliverables. The risk analysis should include programming timing; resources;
development costs and investments; potential for, and effects of, possible failures in
processes, including your suppliers. You should also consider financial and profitability risk.
The results of your assessment must be recorded on the applicable APQP form. Review
specific requirements for feasibility at OEM customer or IATF websites.
 Sometimes it may take a few months to receive an order or contract from the
customer, after you have sent them your quotation. Your review process must ensure that
you compare the customer’s order or contract with your latest quotation, and resolve any
differences (accept or re-negotiate), before you accept the order or contract.
 Your customer relations management process must include a sub-process for change
control and must include – a review of the change (from customer or internal) and its
impact on fit, form, functionality, other processes, financial, delivery, etc. again, use
applicable sections of APQP to address change control.
 Obtain customer approval in writing for any waivers of contractual or QMS
requirements.
 Customer communications may take many forms including – customer representative
(see clause 5.5.2.1); industry recognized computerized interfaces and software for product
(EDI; CAD); Customer provided software and interfaces for design and development,
logistics, customer satisfaction feedback, etc; multi-disciplinary OEM/Supplier teams for
product programs; etc. You must ensure that personnel at all levels have the competency
and training to use these communications media and tools. Review specific communication
document all processes addressing this clause as part of your QMS (see clause 4.1). For
these processes, you must also identify what specific documents, controls and resources are
needed (see clause 4.2.1d. and 7.1b.). You could use a documented procedure or other
combination of practices, procedures and methods that may not necessarily require
documentation. Look at the risks related to your product, processes and resources in
determining the extent of documented controls you need to have (also see clause 4.2.1
notes).
 Performance indicators (to measure the effectiveness of customer-related processes in
meeting requirements and achieving quality objectives) should focus on reducing variation
in and improving these processes and related use of resources. Indicators may include
reduction in - quote cycle time; pre and post-award review cycle time; order entry errors
and omissions; etc., and improvement in conversion ratio (i.e. ratio of contracts/orders
awarded to quotes). It might be quite useful to obtain feedback relating to why
jobs/contracts were lost.
 For performance indicators for customer communications processes, see clause 5.5.3
first paragraph of key explanation points and tips.
TS16949 Page 66
7.3.1 D&D Planning
17:00
7.3 Design & Development Planning
7.3.1 Product design and development (d & d) planning

You shall plan and control the design and development of product
During design and development planning, determine:
a) design and development stages
b) appropriate review, verification, and validation at each stage
c) responsibilities and authorities
Manage the interfaces between the different groups involved to ensure:
 effective communication
 clear assignment of responsibility
Update the planning output as needed, as the d & d activity progresses
Note : Clause 7.3 applies to both product and manufacturing d & d and focuses on
error prevention rather than detection
7.3.1.1 Multidisciplinary approach

You shall use a multidisciplinary approach to develop, monitor & review:
- Special characteristics,
- FMEA’s, including actions to reduce potential risks
- Control plans
Note: A multidisciplinary approach may include design; manufacturing; engineering;

quality; production, etc.

 Clause 7.3 must include the d & d of both the product as well as the manufacturing
process and extends throughout the product program life.
 The scope of your d & d activity must consider all aspects of the product and product
realization processes to ensure its conformity to requirements. This includes product
identification, handling, packaging, storage and protection during internal processing and
delivery to the customer.
 Product d & d sometimes results in new manufacturing processes or changes to
existing manufacturing processes. This clause is equally applicable for designing and
developing manufacturing processes.
 Planning must focus on error prevention rather than detection in product as well as
manufacturing d & d.
 You must have an overall plan for your design project. Your plan must specify the
design and development stages, activities and tasks; responsibilities; timeline and
resources; specific tests, validations, and reviews; and outcomes. There are many tools
TS16949 Page 67
available for planning ranging from a simple checklist to complex software. Use your
customer-specific manuals for APQP as a good starting point.
 The degree and details of planning may vary according to size and length of contract or
project, complexity, risk, product life, customer and regulatory requirements, past
experience with similar product, etc. You have flexibility in determining the scope of the
stages, review, verification and validation required for your product d & d projects.
 Your plan must be dynamic and updated as requirements and circumstances change.
You must track progress against your plan at regular intervals or project milestones and
update the plan as activity progresses.
 You must use a multi-disciplinary approach, that includes as needed, other functions
(besides design) such as quality, engineering, purchasing, sales, tooling, production, etc..
Your plan must clearly identify these other functions and their specific role and
responsibilities regarding the project. Consider including customer and supplier personnel at
appropriate stages to do work and review results or progress. Consideration must also be
given to the methods of communication and interaction. Inclusion of these controls in your d
& d plan is one of many effective ways to achieve this.
 A multi-disciplinary approach has the benefit of applying collective and relevant
knowledge and skills of these different functions to carry out or review d & d activities
 You must use the multi-disciplinary approach for specific activities such as
determination of special characteristics, conducting FMEA’s, developing control plans, and
plant and facility planning, etc. Review specific requirements for multi-disciplinary approach
at OEM customer or IATF websites.
 The d & d project plan serves as both a document and a record as it is updated for
completion for various activities.
 Where some or all of the design responsibility is subcontracted or done off-site, then
you must ensure that your organization and the subcontractor or off-site location
collectively address all the requirements of clause 7.3 with particular coverage of the
interfaces between them
 You must review all input requirements; review d & d progress; verify product design
and validate developed product at various stages of your d & d process. The nature,
frequency and scope of these controls must be defined in your d & d plan or other
document. You must carry out these controls according to your plan and keep appropriate
records (see record requirements in clauses 7.3.4; 7.3.5; 7.3.6 and 7.3.7).
these processes, you must also identify what specific documents are needed for effective
planning, operation and control of production activities (see clause 4.2.1d). These
documents may include – contracts; technical drawings and specifications; a documented
plan for d & d; work instructions; a documented procedure; etc., combined with unwritten
practices, procedures and methods.
 Look at the risks related to your product, processes and resources in determining the
nature and extent of documented controls you need to have (also see clause 4.2.1 notes).
Many organizations use various software tools to document their product or process d & d
plans.
 Performance indicators (to measure the effectiveness of design and development
processes in meeting requirements and achieving quality objectives) should focus on
reducing variation in and improving these processes and related use of resources. Indicators
may include reduction in – design cycle time; development cycle time; specification errors,
omissions; changes; d & d costs; etc., as well as measurableimprovements in products
developed.
TS16949 Page 68
7.3.2 D&D Inputs
17:00
TS 16949 7.3.2 Design & Development Inputs

Determine inputs to product requirements that include:
a) functional and performance requirements
b) applicable statutory and regulatory requirements
c) applicable information from previous similar designs
d) Other requirements essential for d & d
Review the inputs for adequacy
Shall be complete, unambiguous, and not in conflict with each other
Note: Special characteristics shall be included in this requirement (see 7.2.1.1).
TS 16949 7.3.2.1 Product Design Input

Identify, document & review inputs relating to:
Customer requirements (contract review) such as special characteristics, identification,
traceability, packaging, etc,.
Use of information - have a process to deploy information gained from various sources
Targets for product quality, life, reliability, durability, maintainability, timing and cost
TS 16949 7.3.2.2 Manufacturing process design input

Identify, document & review mfg process design inputs relating to:
• Product design output data;
• Targets for productivity; process capability and cost;
• Customer requirements if any;
• Experience from previous developments
Note: Use of error proofing methods in manufacturing process

design appropriate to magnitude of problems experienced and risks
encountered
TS 16949 7.3.2.3 Special Characteristics

Identify special characteristics in Control Plan (CP) and:
- Use customer specified definitions & symbols on CP’s, drawings, FMEA’s, operator
instructions
- Or use company symbols on above
Note: SC’s may include product characteristics or process parameters
TS 16949 Key Explanation Points and Tips:
TS16949 Page 69
 Use your customer specified APQP reference manual as a good tool for d & d planning
and control.
 Product d & d is only applicable if you are designated as being design-responsible.
Determine (in writing) from your OEM customer if you are designated as being design
responsible. You must apply all relevant requirements of clause 7.3 for manufacturing
process d & d.
 You must identify, document and review design inputs requirements for function,
performance, safety, regulatory, quality, reliability, durability, life, timing, maintainability,
cost, identification, traceability, packaging, special or safety characteristics (from the
customer or regulatory body), and other requirements essential to the product.
 You must have a process to deploy (identify, document, review and use) design input
information coming from various sources such as - customer contracts, drawings and
specifications; your own organization’s database of previous d & d projects; competitor
analysis; industry standards; feedback from suppliers; field data.
 You must identify, document and review manufacturing process design input that
include – product design output data; targets for productivity; process capability and cost;
customer requirements for manufacturing, if any; and experience from past d & d projects
and manufacturing activities; and the use of error-proofing methods appropriate to the size
of problems and risks experienced.
 You must have a process to deploy (identify, document, review and use) manufacturing
process design input information coming from various sources.
 You must identify and include all special and safety characteristics (using the
customer’s or your own equivalent symbol or notation) in your process control documents
such as - control plan; FMEA’s drawings; operator instructions and other documents used to
make or verify product. Note that special characteristics can also include process
parameters such as temperature, timing, concentrations, etc. Review specific requirements
for special characteristics at OEM customer or IATF websites.
 Not all products or processes necessarily have special characteristics. You may define
them as appropriate and include them in the documents mentioned above. Guidance in
determining special characteristics, comes from customer requirements; regulatory
requirements and analysis of previous concerns
 You must review all input requirements for adequacy and completeness. You must
ensure that requirements are complete, clear and consistent with each other.
 Clause 7.3.2 is closely associated with clause 7.2.1 and 7.2.2 – determining and
reviewing customer requirements.. Accordingly, you must keep appropriate records of
identification, documentation and review of input data.
TS16949 Page 70
7.3.3 D&D Outputs
17:01
7.3.3 D & D Outputs
You shall:
Provide d & d outputs in a form that enables verification against d & d inputs
Approve d & d outputs prior to their release
repare design and development output to:
a) meet d & d input requirements
b) provide appropriate information (for purchasing, production, and service)
c) contain or reference product acceptance criteria
d) specify characteristics of the product essential for its safe and proper use
7.3.3.1 Product design output – supplemental

Express product design output in terms that can be verified & validated against product
design input requirements
Product design output shall include:
 Design FMEA, reliability results,
 Product special characteristics and specifications
 Product error-proofing as appropriate
 Product definition including drawings and math based data,
 Product design review results
 Diagnostic guidelines where applicable
7.3.3.2 Manufacturing process design output
Express manufacturing design process output in terms that can be verified & validated
against manufacturing design input
Manufacturing design output shall include:
 Specifications and drawings
 Manufacturing process flowchart/layout
 Manufacturing process FMEA’s
 Control Plans (7.5.1.1)
 Work instructions
 Process approval acceptance criteria
 Data for quality, reliability, maintainability & measurability
 Results of error-proofing results, as appropriate
 Methods for rapid detection and feedback of product/manufacturing process
nonconformities.
TS16949 Page 71
 Product d & d output may be product or documentation or both. Product may be
prototype or finished product and documentation could be in computerized or hardcopy
form. A manufacturing d & d output may be a physical manufacturing process as well as
documentation. See examples of both in Clauses 7.3.3.1 and 7.3.3.2 above).
 Check product d & d output against the input requirements specified in
7.3.2, before you use it any further. Express product design output in any or all the forms
specified in 7.3.3.1.
 Provide appropriate information to purchasing (material or service specifications);
production (product specifications, special characteristics, drawings, FMEA’s, diagnostics,
etc.); service (product specifications; performance reliability and maintenance criteria).
Initially, this information may be used for trials and validation, before being firmed up.
 The product design output should result from a process that includes efforts to simplify,
optimize, innovate and reduce waste. The design process should include:
 Analysis of cost, performance and business risks and trade-offs
 Appropriate use of geometric dimensioning and tolerancing
 Design for assembly (DFA); Design for manufacturing (DFM); design of experiments
(DOE); quality function deployment (QFD); Value engineering (VE)
 Tolerance studies and appropriate alternatives
 Use of Design FMEA’s
 Use of feedback from testing, production and the field
 Diagnostic guidelines in clause 7.3.3.1 refers to systems software/equipment for field
servicing that requires engineering based data essential to service the vehicle.
 Manufacturing process ; Check manufacturing process d & d output against input
requirements specified in 7.3.2.3. Express manufacturing design output in any or all the
forms specified in 7.3.3.2.
 The manufacturing process design output should result from a process that includes
efforts to simplify, optimize, innovate and reduce waste such as lean manufacturing tools
that include:
 ANDON system (line control system)
 Error proofing; level scheduling; pull system inventory control;
 Synchronous manufacturing (single-piece flow)
 Visual controls
 Workplace organization and layout
 Many documents are created from the d & d output stage (drawings, FMEA’s, control
plans, etc). These documents must be controlled as per clause 4.2.3 of this standard
(approval; revision control, distribution, etc).
 Many sophisticated d & d tools are required to be used as indicated above. You must
provide and keep records of appropriate competence and training for functions performing d
& d activities.
TS16949 Page 72
7.3.4 & 7.3.5 & 7.3.6 D&D Verification, Validation & Control
17:02
7.3.4 D & D Review

You shall:
Perform systematic review of d & d at suitable stages as per your plan (see 7.3.1) to:
a) Evaluate the ability of d & d results to meet requirements
b) Identify any problems and propose actions
Include representatives of functions concerned with the d & d stages being reviewed
Maintain records of such reviews and any actions arising from them
Note: These reviews are normally coordinated with the design phases and include
manufacturing process d & d.
7.3.4.1 Monitoring
You shall define, analyze and report (in summary) measurements at specified stages of d &
d, as an input for management review
Note: These measurements include quality risks, lead times, critical paths and others as
appropriate.

 Do design reviews at one or more milestones of the d & d project, depending on
customer requirements, the size, complexity and risks involved. The purpose of these
reviews is to evaluate results to requirements, check project progress and costs to plan (see
7.3.1) and take actions on any problems encountered. Review specific review requirements
 You must take multi-disciplinary approach for doing these reviews and keep
appropriate records of issues discussed, actions to be taken, responsibilities and timeline for
completion.
 All d & d reviews must be included in your d & d plan.
 The summary of measurements at specific stages of d & d must be added to the
management review agenda (see clause 5.6.2). You will notice this is not listed there.
7.3.5 D & D Verification

Perform verification in accordance with planned arrangements (see 7.3.1) to ensure that d
& d outputs satisfy d & d input requirements.
Maintain records of the results of verification and any necessary actions
7.3.6 D & D Validation

Perform validation in accordance with plans ( see 7.3.1)
Ensure that the product meets requirements for the specified application or intended use,
where known
TS16949 Page 73
Complete validation before delivery or implementation (wherever practical)
Maintain records of the results of validation and any necessary actions
Note 1 The validation process normally includes an analysis of field reports for similar
products
Note 2 Verification (7.3.5) & validation (7.3.6) apply to both product d & d as well as
manufacturing process d & d.
7.3.6.1 D & D Validation- supplemental

Perform validation in accordance to customer requirements including program timing.

 Product design Verification includes – design reviews (see 7.3.4); comparing the new
design to a similar proven design if available; performing alternate calculations; performing
tests and simulations; reviewing the design documents before release, etc.
 Verification is checking product or process to input requirements, whereas validation is
checking product or process is suitable for it’s intended use - does it perform/function in
the way intended by your customer or your organization.
 Manufacturing process design verification include – design review (see 7.3.4); process
capability studies; testing various process parameters; performing tests and trials;
reviewing the manufacturing process design documents before release, etc.
 Product and manufacturing process validation includes – design reviews; comparison
between customer requirements and internal development plans; d & d validation against
customer requirements and d & D input requirements; corrective action and lessons learned
from documented process failures and product nonconformities. Review specific verification
and validation requirements at OEM customer or IATF websites.
 You must keep records for both verification and validation activities.
TS16949 Page 74
7.3.6.2, 7.3.6.3 & 7.3.7 Prototype, PPAP, Changes
17:03
7.3.6.2 Prototype program

When required by the customer, you shall have a prototype program & control plan.
Wherever possible, use the same suppliers, tooling and manufacturing processes as in
production
Monitor all performance testing for timely completion & conformance to requirements
Be responsible for, control and show technical leadership for any outsourced design
services

 Your d & d project plan must include your prototype program. Use a prototype control
plan to manage the development of a specific product. Use existing approved suppliers,
tooling and manufacturing processes to save time and risk. Review specific requirements for
prototype programs at OEM customer or IATF websites.
 Monitor internal and supplier activities to both your d & D project plan as well as your
prototype control plan.
 You must have a process for outsourcing activities (e.g. tooling). You must include this
process as part of your QMS (see clause 4.1).
7.3.6.3 Product Approval Process

You shall:
Use and conform to the customer approved product & manufacturing process approval
procedure (e.g., PPAP Manual).
Apply the same approved procedure to your suppliers
Note: Product approval should follow the verification of the manufacturing process

 Use the customer provided or recognized procedure provided procedure if one exists,
otherwise use the appropriate OEM PPAP reference manual. Review specific requirements
for PPAP at OEM customer or IATF websites.
 Make your suppliers use the same procedures or manual as you do. If supplier PPAP’s
are done by your purchasing function that is located off-site, make sure that both the offsite
purchasing process as well as the PPAP process is identified in your QMS processes (see
clause 4.1).
7.3.7 Control of D & D Changes

You shall:
Identify and maintain records of changes
Review, verify, and validate the changes (as appropriate)
TS16949 Page 75
Approve the changes before implementation
Evaluate effect of changes on constituent parts and product already delivered
Maintain records of the results of such reviews and any necessary actions
Note: D & D changes include all changes during the product program life (see 7.1.4)

 Make sure your process for d & d changes follow appropriate steps of clause 7.3 (define
plan, have inputs and outputs, verify and validate) to the extent necessary to meet
customer requirements and control product, quality and business risks.
 Changes may come from internal, customer or regulatory sources. Get all requests for
product or manufacturing process design changes in writing from your customer! Review
specific requirements for design changes at OEM customer or IATF websites.
 Impact of the change must be evaluated on – materials used; design process;
manufacturing process; characteristics and use of developed product; regulatory
compliance; cost; etc.
 Closely linked clauses include 4.2.3.1 and 7.3.6.3
TS16949 Page 76
7.4.1 Purchasing Process
17:05
7.3 Purchasing
7.4.1 Purchasing Process

Ensure that purchased product conforms to specified purchase requirements
Base the type and extent of control of your supplier and purchased product, upon the effect
the purchased product has on your subsequent product realization and final product
Evaluate and select suppliers on their ability to supply you with product in accordance with
your requirements
Establish criteria for the selection, evaluation and re-evaluation of suppliers
Maintain records of evaluation results and actions
Note 1 : Purchased product includes all products & services that affects customer - sub-
assemblies, sequencing, sort, rework & calibration services
Note 2 : Verify the continuity of your supplier’s QMS & its effectiveness if there are
merger, acquisition, affiliations associated with your suppliers.
7.4.1.1 Regulatory Conformity

Purchased product or materials shall conform to applicable regulatory requirements
7.4.1.2 Supplier QMS development

Develop your suppliers to conform to TS 16949. As a first step, they shall be ISO 9001
certified, unless otherwise specified by your customer.
Note: Prioritize supplier development based on their quality performance & importance
of product supplied.
7.4.1.3 Customer-approved sources

Where specified by contract (customer drawing or specification), you shall purchase
products, materials, tool/gauge and services from approved sources.
Using customer designated supplier, including tool/gauge suppliers does not relieve your
organization of the responsibility to ensure the quality of purchased product.

 Clause 7.4 covers the following purchasing activities:
 Requirements to control purchased product (clauses 7.4.1; 7.4.1.1; 7.4.3; 7.4.3.1)
 Requirements to control suppliers you buy from (7.4.1; 7.4.1.2; 7.4.1.3; 7.4.3.2
 Requirements controlling your buying process (7.4.2)
 Purchased product includes raw materials, components, subassemblies, supplies,
tooling, machinery and equipment, sequencing, sorting, rework, testing, calibration,
TS16949 Page 77
maintenance, etc.
 Note that clause 7.4 requirements also apply to customer provided property which
might include materials, production equipment; tooling; measuring and test equipment;
facilities; transport vehicles; returnable packaging; intellectual property (drawings,
specifications or proprietary information); product returned for servicing under warranty,
product sent for outsourced work; etc.
 You must have specifications/criteria for purchased product. These specifications may
come from your organization, customer, regulatory bodies, supplier or industry. As
documents, these specifications must be controlled as per clause 4.2.4
 Many times the customer may require the use of pre-approved purchased products and
suppliers. The onus is still on you to ensure that purchased product from customer-
designated sources meets all requirements.
 You must control both, the product that you buy, as well as the supplier you buy from.
Clauses 7.4.3 and 7.4.3.1 and 7.3.6.3 PPAP deal with requirements to control the products
you buy. Your controls must primarily be based on prevention of nonconformities in both
product and supplier performance.
 And clauses 7.4.1(second paragraph), 7.4.1.2; 7.4.1.3; 7.4.2c; 7.4.3.2 and 7.3.6.3
PPAP deal with requirements to control the suppliers you buy from.
 Determine how important the purchased product is to design, manufacture, assemble
and maintain your end product. Keep in mind clause 7.3.2.1 which requires targets for
product quality, life, reliability, durability, maintainability, timing and cost. You must apply
similar criteria to purchased product going into your end product.
 Categorize your purchased products accordingly. Then determine what controls you
need to ensure consistent purchased product quality and consistent supplier performance.
You can apply different controls for different purchased products and suppliers.
 Besides product quality, your criteria for supplier selection and evaluation may include
the potential supplier’s - financial capability; technical and manufacturing capability and
capacity; reliability; reputation; flexibility to handle changes; support; service; cost; etc.
The importance of these criteria will vary according to the items materials or services you
purchase, and so you can apply different criteria to different supplies. You can categorize
your suppliers accordingly based on these criteria. It might be useful to maintain a list of all
qualified suppliers.
 Not all suppliers of purchased product need to conform to TS 16949. Look at the
importance of the purchased product and their quality performance, to qualify them and
prioritize their QMS development.Supplier - refers to your suppliers manufacturing site
where production and/or service parts are made.
 You must promote and encourage your qualified or key suppliers to develop their
QMS - starting with registration by an accredited 3rd party Certification Body (CB) to ISO
9001:2000 (unless, otherwise specified by the customer) and eventually leading to
conformity to the latest TS 16949 standard. Your supplier QMS development process could
include a plan for qualified suppliers to achieve ISO certification and TS conformity within
the 3 year life cycle of your organization’s registration certificate.
 If supplier development according to the above plan is not possible, then get
approval in writing from affected customers for an alternate approach to supplier
development, e.g. assessment by a OEM customer approved second party. Very small
supplier organizations may obtain special dispensation from their OEM customers from
obtaining ISO 9001 or TS 16949 certification under certain conditions. Please review specific
requirements for subcontractor development at OEM customer or IATF websites.
 Where there are multiple customers for a purchased part or supplier, you must ensure
that your purchased part and supplier meet all specific customer requirements (e.g. PPAP
requirements).
 Where OEM customer approved suppliers are used, you must still apply all applicable
TS 16949 control requirements to manage these suppliers. Also review specific
TS16949 Page 78
requirements for customer approved suppliers at OEM customer or IATF websites.
 As per clause 4.1, you must identify your purchasing processes whether on site or off
site. For each process, you must document the controls for purchased product and
suppliers. You must also show the linkage and interaction of purchasing processes with
other processes such as design, manufacturing, tooling maintenance, calibration, etc.
 Where any of your controlled suppliers have gone through a significant organizational
change (mergers, acquisitions, etc), you must verify (e.g. get a copy of their latest ISO
9001 certification) the continuity and effectiveness of their QMS.
 You must keep records of all supplier evaluations (whether initial or periodic), including
any corrective actions placed on them for any nonconformities.
 Performance indicators (to measure the effectiveness of purchasing processes in
meeting requirements and achieving quality objectives) should focus on measuring supplier
performance and reducing variation in and improving purchasing p rocesses and related
use of resources.
 Indicators for supplier performance may include – reduction of defects in supplied
product; scrap; waste and rework; improvement in on-time delivery, service, cost, etc.
Indicators for purchasing process may include reduction in supplier – quote review cycle
time; contract award cycle time; purchase order-entry errors and omissions; receiving
errors & omissions; etc.
 For performance indicators on supplier communications processes, see clause 5.5.3
first paragraph of key explanation points and tips.
TS16949 Page 79
7.4.2 & 7.4.3 Purchasing Information & Verification Purchased
Product
17:06
7.4.2 Purchasing Information

You shall describe the product to be purchased and include where appropriate requirements
for:
a) approval of product, procedures, processes and equipment
b) qualification of personnel
c) quality management system
You shall ensure the adequacy of specified purchase requirements before communicating
them to the supplier

 Your purchase documents (purchase order, contract, blanket order, your organization’s
supplier quality manual, etc.) must specify your requirements for the purchased product;
the suppliers QMS and any other initial or on-going controls you deem necessary for
ensuring consistent supplier performance.
 You must define how you ensure the adequacy of these documents before you
communicate them to your supplier. A review of adequacy of purchasing documents may
include their completeness, accuracy, correctness, quantity, timing, cost, approval, etc., by
one or more functions; computerized controls, etc.
 In larger organizations, this may be a separate process on-site or off-site. In either
case, it must be identified and controlled as per clause 4.1 along with 7.4.2.
 While clause 7.4.2 does not specify keeping of records, you must show evidence of
carrying out (issue purchase documents) and review of these documents. (see clause 7.1d
and 4.2.4 first sentence).
7.4.3 Verification of Purchased Product

You shall:
Establish and implement inspection or other activities necessary to ensure that purchased
product meets specified purchase requirements
For any verification at supplier premises (by your organization or customer), state in the
purchasing information:
 Your intended verification arrangements
 and method of product release
7.4.3.1 Incoming product quality

Have a process to verify the quality of purchased product. Your process shall use one or
more of following :
 Receipt & evaluation of statistical data provided by the supplier
 Receiving inspection and/or testing - e., sampling based on performance
TS16949 Page 80
 2nd or 3rd party audits of supplier sites when combined with records of acceptable
delivered quality performance
 Part evaluation by a designated laboratory
 Any other method agreed to by your customer

 Use the APQP process to evaluate the risks and controls needed for products or product
groups. Include or refer to these controls for incoming product in your Control Plans. Review
specific requirements for incoming product quality at OEM customer or IATF websites.
 The standard provides several options for verifying incoming product quality. You can
use different combinations for different products and suppliers depending on their ongoing
performance. In any case these must be included or referenced in your Control Plans.
 Your incoming inspection process must define and document the criteria for doing this
and what records you keep to show effective control of purchased product quality and
supplier quality perfromance.
 Statistical data must relate to product characteristics or process parameters from the
production run from which the product came from. It should include any special and
regulatory characteristics (for product or process) where designated by the customer or
your own organization.
 You must define and document the acceptance criteria for all sampling plans. Check if
any of your customers require approval of your sampling plans.
 Third party assessments must be done by an accredited registrar. Parties conducting
second party assessments may need to be approved by your customer.
 Designated laboratories must be ISO/IEC 17025 accredited or have evidence from your
customer, that they are acceptable for carrying out part evaluations.
7.4.3.2 Supplier Monitoring

You shall monitor your suppliers performance through the following indicators:
 Delivered product quality
 Customer disruptions including field returns
 Delivery schedule performance (including incidents of premium freight)
 Special status customer notifications for quality or delivery issues
Promote suppliers to monitor the performance of their manufacturing processes

 On top of the initial evaluation and approval of suppliers, you are required to carry out
ongoing monitoring of their performance.
 Use supplier monitoring indicators to evaluate the consistency, capability and reliability
of their performance for quality, delivery, support, etc. Various tools are available to do
this.
 On-time delivery is very important and disruptions (due to waiting for materials) at
your customers or even your own facility must be avoided. Review specific requirements for
on time delivery and scheduling at OEM customer or IATF websites.
 You must track and evaluate all occurrences of premium freight on incoming deliveries,
TS16949 Page 81
whether caused by you or your supplier. You must take corrective action where there a
significant premium freight problem.
 If you have the misfortune to be put on hold, special alert or notification status by any
of your OEM customers, the process for getting out of it can be very time-consuming and
costly. Therefore, besides controlling your own product and delivery performance (see
clause 8.2.1.1), make sure that you are on top of your supplier’s product quality and
delivery using effective evaluation and monitoring controls as well as an effective problem
resolution process when problems do arise.
 You must encourage your suppliers to monitor their own manufacturing performance.
Motivate them to use lean manufacturing tools such as – ANDON procedures; direct run first
time quality results; lead time reduction; level scheduling; number of error-proofing
opportunities implemented; planned maintenance; standardized work; workplace
organization and visual controls deployed.
TS16949 Page 82
7.5.1 Control of Production and Service Provision
17:07
7.5 Production & Service Provision
7.5.1 Control of Production and Service Provision

Plan and carry out production and service under controlled conditions which shall include (as
applicable) the:
a) Availability of information that describes the product characteristics
b) Availability of work instructions, as necessary
c) Use of suitable equipment
d) Availability and use of monitoring and measuring devices
e) Implementation of monitoring and measurement
f) Implementation of release, delivery and post-delivery activities
7.5.1.1 Control Plan (CP)

Develop Control Plans for:
 For system, subsystem, component or material level for the product supplied,
including processes for bulk materials and parts
 Pre-launch & production taking into account design & manufacturing FMEA outputs
Control Plans shall include:
 Controls for manufacturing processes
 Customer required information
 Methods to monitor control over special characteristics (both - customer &
organization)
 The reaction plan when processes become unstable or not statistically capable
 Review & update Control plans for changes that affect product, manufacturing
process, measurement, logistics, supply sources or FMEA (see 7.1.4).
Note: Get customer approval if required, after review or update of the control plan.
7.5.1.2 Work Instructions (WI)

Have documented work instructions, accessible at work stations, for all employees
responsible for processes impacting quality.
These WI’s shall be derived from sources such as the Quality plan, Control plan and product
realization processes

 Identify and control all production processes as per clause 4.1; 7.l and 7.5. Show the
interaction of these processes with other processes. Use the APQP reference manual to plan
and control production and service activities.
TS16949 Page 83
 The key output of the APQP (your quality plan) process are control plans and work
instructions. Each part must have a control plan, but in many cases, family control plans
may cover a number of similar parts produced using a common process
 For each product or part family, control plans must cover all production process steps
from - receipt of materials, production, packaging, storage, delivery and even post-delivery
activities such as installation or training.
 Consider using FMEA’s and control plans in other areas of your organization, such as
equipment and facility maintenance; laboratory; tooling operations, etc.
 Control plans and work instructions originate as an output from Design and process
FMEA’s (see clause 7.3.2.3 and 7.3.3.2). They define complete controls for the manufacture
of product. Use them for pre-launch and production of end product, sub-assemblies,
components and/or materials. They must include the customer’s and your special
characteristics, any other customer required information and a reaction plan when
processes fail. Review specific requirements at OEM customer or IATF websites.
 Work instructions may be viewed as a subset of your quality plan and may relate to a
specific task or activity of your overall product realization process (e.g. setting up a
machine; performing an inspection; packaging a product). If you determine that work
instructions are needed at specific points in your process, then they must be readily
available and relevant i.e. current or right version (see clause 4.2.3d). Note that work
instructions may exist in may forms – narrative; graphical; audio; video; physical display;
etc. Review specific requirements for work instructions at OEM customer or IATF websites.
 In combination, these documents address what has to be made; how much has to be
made; when it has to be made; by whom; in what sequence; how it has to be made; what
production equipment to use; what measurement and monitoring tools to use ; when to
inspect; how much to inspect; what to do if problems arise, etc.
 These documents are dynamic and must be updated for the changes specified in
7.5.1.1. Your control plans must reference the work instructions specified for the process
steps.
 Don’t forget to use the multi-disciplinary approach in developing your Control Plans.
Clauses related to clause 7.5.1.1 include - 7.1.4; 7.3.6.3; 7.3.1.1; 7.3.3.2; 7.3.2.3;
7.3.6.2; 8.2.3.1; 4.2.3.1; 8.5.2.
 To improve your QMS, it will be very useful to draw a flow chart to link the flow and
interaction of the activities and sub-processes covered by these clauses, e.g. many
organizations overlook reviewing and updating their FMEA’s and control plans for corrective
action taken to address a manufacturing process problem.
 Collectively, these documents include or reference the following information:
 Current engineering level/date; customer or your special characteristics; inspection and
test instructions with acceptance criteria (see clause 7.1.2 and 8.2.3.1); material
identification and disposition instructions; operation name and number keyed to the process
flow diagram; part name, number and family; reaction plans; relevant engineering and
manufacturing standards; required tools, gages and other equipment; revision dates and
approvals; SPC and other process monitoring requirements; tool-change intervals and set-
up instructions; visual aids, etc.
 Production personnel must have timely access to all information relevant to their
activities. There may be serious risk to production flow, if such information is unavailable or
untimely.
needed (see clause 4.2.1d. and 7.1b.). You could use your control plan; a documented
procedure or other combination of specific practices, procedures, work instructions; and
other documents and methods. Look at the risks related to your product, processes and
TS16949 Page 84
resources in determining the extent of documented controls you need to have (also see
clause 4.2.1 notes).
 Performance indicators (to measure the effectiveness of production processes in
meeting requirements and achieving quality objectives) should focus on reducing variation
in and improving production processes and related use of resources.
 Indicators for production processes be product or process related. Product related
indicators may include reduction - in defect rates, PPM’s (defective parts per million), scrap
rates, waste and rework; improvement in on time delivery, inventory turns (see clause
7.1a).
 Production process related indicators may include – reduction in set-up time; run rates;
process cycle time; production scheduling and operator errors and omissions; etc.
7.5.1.3 Verification of job set-ups

Verify job set-ups whenever performed as at initial run, material or job change.
Provide WI’s to set up personnel & use statistical methods of verification where applicable
Note: Last-off part comparisons are recommended

 Job set-ups relate to changes in tooling, equipment, materials, shifts, personnel, etc.
You must determine the importance of set-ups in terms of time taken and risks related to
product quality, in determining the extent of set-up verification, methods used and details
of work instructions made available to set-up personnel. Tooling FMEA’s provide very useful
input to determine this.
 Verification of job set-ups may include – data on and comparison of the last series
(quality records, corrective actions); completeness of equipment and documentation for
production, inspection and testing; responsibilities for release after set-up; disposition of
pre-launch or set-up scrap; comparisons of last piece with specified requirements and first
piece of new run, etc. Review specific requirements for job set-ups at OEM customer or IATF
websites.
 Include job set-up controls in your control plans.
7.5.1.4 Preventive & Predictive maintenance

Identify key process equipment & provide resources for their maintenance. Develop an
effective planned total preventive maintenance system which as a minimum shall include:
- planned maintenance activities;
- packaging & preservation of equipment;
- packaging & preservation of equipment, tooling & gauging
- replacement parts for key manufacturing equipment
- documenting, evaluating & improving maintenance objectives
Use predictive maintenance methods to continually improve the effectiveness & efficiency of
equipment

 See notes under clause 6.3
TS16949 Page 85
 Perform a FMEA on the various types of process equipment you use, to identify key
process equipment to include in your program for planned total preventive maintenance
system. Consider doing this by equipment groups, if all equipment within a group operates
in the same way. Identify maintenance as a process within your QMS as per clause 4.1,
including any outsourced maintenance activities.
 Your planned preventive maintenance program should include – schedule and timing;
availability and training of personnel; types and scope of maintenance; records; tracking to
maintenance objectives; use, storage and control of spare parts; control of any
maintenance outsourcing; etc. There are many software programs available to help do this.
 Predictive maintenance methods should include a review of manufacturer’s
recommendations; storage; tool wear; optimization of uptime; correlation of SPC data to
predictive maintenance activities; important characteristics of perishable tooling; fluid
analysis; monitoring of circuits; and vibration analysis. Check sub-clause 3.1.7 and 3.1.8
under Terms and Definitions - clause 3 of this standard. Review specific requirements for
maintenance at OEM customer or IATF websites.
 Include, as appropriate, maintenance of equipment in your control plans.
7.5.1.5 Management of production tooling

Provide resources for tool & gauge design, fabrication & verification activities
Use a tooling management system that includes:
 Maintenance & repair facilities & personnel
 Set-up, storage and recovery
 Tool change programs for perishable tools
 Documentation for tool design modification, including engineering change level
 Tooling identification that defines status, such as production, repair or disposal
Implement a system to monitor these activities, if any of them is outsourced.
Note: Tooling management also applies to availability of tools for vehicle service parts

 Tooling and tooling management may be a significant part of your product realization.
Tooling includes tooling for production as well as vehicle service parts. Consider doing a
FMEA’s for tooling design, fabrication, verification, storage, set-up and operation. You will
be surprised how much you will discover and much more effective and efficient your tooling
operations will become.
 You must include tooling and its sub-processes within the scope of your QMS (see 4.1).
Make sure you document the interaction of tooling with other processes such as design,
purchasing, production, maintenance, etc. This includes outsourcing of any of the tooling
processes. Review specific requirements for tooling management at OEM customer or IATF
websites.
 Make sure you have appropriate records for competency and training of tooling
personnel, as well as records for effective planning, operation and control of each activity
listed in clause 7.5.1.5.
 The system you use to monitor any outsourcing must be similar to the controls
required if done in-house and you will be required to show evidence of such controls over
outsourced work. Customer provided tooling and equipment must be marked or identified as
such (see clause 7.5.4.1).
TS16949 Page 86
 Reference appropriate tooling and equipment in your control plans and/or work
instructions.
7.5.1.6 Production Scheduling

You shall schedule production to meet customer requirements such as just-in-time
supported by an information system that provides access to production information at key
stages. Production scheduling shall be order driven

 Your production scheduling must be order-driven. Use methods such as just in time;
material requirements planning; customer EDI; use of pull systems; small lots for one piece
flow; etc, to manage and achieve this.
 Carefully define and document the interaction of your production scheduling process
with your logistics processes such as inventory management; customer communication;
traffic and shipping control; packaging and labeling; sales and billing.
7.5.1.7 Feedback of service information

Have a process to communicate information on service concerns to design, engineering &
manufacturing activities.
Note: The intent of this sub-clause is to ensure your organization is aware of
nonconformities that occur externally.

 Define and document your process to provide feedback to production, engineering and
design. This should include feedback from OEM’s; customers; as well as vehicle owners
through auto dealerships and industry/regulatory research/focus organizations.
 You are required to evaluate failures and concerns from the field. You must consider
either an immediate corrective action (i.e. a recall for a safety or regulatory violation) or
review them through your APQP process and update, as appropriate, your product
specifications FMEA’s; control plans, work instructions, PPAP, etc.
7.5.1.8 Service agreement with customer

Where there is a service agreement with your customer , you shall verify the effectiveness
of:
 Your service centers
 Any special purpose tools or measurement equipment
 Training of service personnel

 If you have a service agreement with an OEM customer either to service product under
warranty or even past warranty, then you must make available appropriate resources for
such services. These services may be performed at your customer or your own facilities.
Appropriate resources include space; transportation; special purpose tools; diagnostic and
measurement equipment; replacement parts and components; availability and use of
TS16949 Page 87
competent personnel. Don’t forget to include this process within your QMS as per clause 4.1
TS16949 Page 88
7.5.2 Validation of Processes for Production and Service Provision
17:08
7.5.2 Validation of Processes for Production and Service Provision

Validate any production or service provision processes where:
 The resulting output cannot be verified by subsequent monitoring or measurement
 Where process deficiencies become apparent only after the product is in use or the
service has been delivered
Validation shall demonstrate the ability of these processes to achieve planned results
Establish controls for these processes, including, as applicable:
a) Criteria for review and approval
b) Approval of equipment and qualification of personnel
c) Use of specified methods and procedures
d) Requirements for records
e) Revalidation
7.5.2.1 Validation of production processes - Supplemental

Apply the requirements of 7.5.2 to all processes for production & service provision

 Validation is usually required where product quality cannot be verified without
damaging or destroying the product, e.g. some types of welding, heat-treating;
electroplating, rust-proofing, etc. In such instances, the quality of these activities may only
be discovered after use. This would generally not be acceptable due to safety (e.g. weld) or
aesthetic (evidence of rust or dullness of chrome) reasons.
 In such cases, validation involves conducting capability studies using a combination of
resources - technology, equipment; materials; environment; competent personnel; and
production and testing methods that consistently result in a quality product or service.
Document the specific procedures; methods; and combination of resources that achieve this
capability, and keep records of ongoing studies to show that you are maintaining this
capability. Validation may also require customer approval of the process (See PPAP clause
7.3.6.3).
 You must keep appropriate records of process validation showing both the achievement
of planned results as well as the ongoing maintenance of such capability (see PPAP clause
7.3.6.3).
 If you change any part of the proven process capability (e.g. materials, equipment or
personnel, etc.), you must revalidate (re-prove) the changed process. It is up to each
organization to determine what combination of resources and methods will provide the
required consistent quality product or service. Include as appropriate, validation controls in
your control plans. You may need to re-PPAP your product and process.
 Performance indicators to measure the effectiveness of processes that validate
production processes may include reduction in - defect rates, PPM’s (defective parts per
million); validation cycle time; revalidations; etc.
TS16949 Page 89
7.5.3 Identification & Traceability
17:08
7.5.3 Identification and traceability

You shall:
- Where appropriate, identify product by suitable means throughout product realization
- Identify the status of product with respect to monitoring and measurement requirements
- Control and record the unique identification of the product, (where traceability is a
requirement).
Note: Configuration management is a means for maintaining identification and traceability

in some industry sectors.
Note: You cannot use location of product as an indicator of inspection and test status,
unless inherently obvious such as material in an automated production transfer process.
Alternatives are permitted if status is clearly identified, documented and achieves the
designated purpose.
7.5.3.1 Identification and Traceability – Supplemental

The words “Where appropriate” in 7.5.3 does not apply to the automotive sector

 There are three distinct control requirements specified here.
 Product identification – means knowing the identity of (yours or customer supplied)
product from - incoming receipt of materials; raw material storage; use in production; work
in progress; finished product storage; and delivery of product to the customer. Product
identification can be controlled using physical and electronic methods.
 Product status – means knowing the quality status (good or bad) of materials and
product through each of the above stages. Product status can be controlled using physical
and electronic methods.
 Unique Product Identification – is not a mandatory requirement under ISO 9001,
unless contractually required by customers. For the automotive or aerospace or
pharmaceutical industry, unique product identification is mandatory for safety, regulatory
and risk management reasons. This usually involves keeping detailed records for – material;
equipment; personnel; processes; production; inspection and test details, etc., for individual
products or production batches. Review specific requirements for identification and
traceability at OEM customer or IATF websites.
 These records help to trouble-shoot product and process problems; resolve customer
complaints; and enables continual improvement of product and process. In many instances,
it also reduces cost, risk and use of resources by narrowing the problem down to a specific
cause or instance. Depending on the product, the OEM may specify the degree of unique
identification and traceability required.
 While this clause does not call for a specific documented procedure, these controls may
be included in your product realization processes through your product control plans; work
instructions and other specific documentation. Examples of product identification and test
status include physical tags, bar code labels linked to computer records; MRP systems
TS16949 Page 90
tracking specific production runs/lots; automated production transfer processes, etc.
 Performance indicators (to measure the effectiveness of processes that control
identification and traceability) may include - reduction in identification errors and omissions;
product quality status errors and omissions; and traceability errors and omissions.
TS16949 Page 91
7.5.4 Customer Property
17:09
7.5.4 Customer Property

Exercise care of customer property while under your control or being used
Identify, verify, protect, and safeguard where provided for use or inclusion in your product
Report to your customer, if their property is lost, damaged, or becomes unsuitable for use.
Keep records of your control of customer property
Note : Includes customer owned returnable packaging and can include intellectual
property
7.5.4.1 Customer owned production tooling

Permanently mark customer owned tools, manufacturing & test equipment so that the
ownership of each item can be visibly identified or determined.

 Customer property may include material; production equipment; tooling; measuring
and test equipment; facilities; transport vehicles; returnable packaging; intellectual
property (drawings, specifications or proprietary information); product returned for
servicing under warranty, product sent for outsourced work; etc. Review specific
requirements for customer property at OEM customer or IATF websites.
 All customer property is exposed to the risk of being damaged, lost, misused;
misplaced; stolen, become unsuitable or obsolete for use. You must establish controls for
each of these risks. Notify the customer in writing if their property is lost, damaged or
otherwise found to be unsuitable (perishable past its shelf life, e.g. paint) for use.
 Control to minimize the risks to customer property include - inventory management;
preservation and storage; identification, status and traceability indicators; maintenance;
notification; traffic flow; authorized use; restricted access; etc. Marking customer property
with a unique identification number that can be traced to a record that provides details of
ownership is one of many acceptable controls.
 This clause requires records to be kept of customer property that is lost, damaged or
otherwise found to be unsuitable for use. This implies tracking the storage and use of and
quality status, of customer property.
instructions and other specific documentation. Many of the controls needed for clause 7.5.3
Identification and traceability and clause 7.5.5 Preservation of product apply to customer
property. The processes, controls and documentation for these other clauses could be
expanded to include customer property.
customer property) may include - reduction in identification errors and omissions; loss due
to damage or unsuitability; scrap; rejects; etc., as well as increased customer property
turnover rates.
TS16949 Page 92
7.5.5 Preservation of Product
17:09
7.5.5 Preservation of Product

Preserve the conformity of product during internal processing and delivery to the
intended destination
Preservation shall include identification, handling, packaging, storage, and protection.
Preservation shall also apply to the constituent parts of the product.
7.5.5.1 Storage & inventory

Assess stock condition at appropriate planned intervals, in order to detect deterioration.
Use a inventory management system to optimize inventory turns and assure stock rotation
such as ‘first in first out’ (FIFO).
Control obsolete stock in a manner similar to the control of nonconforming product

 All raw materials, work in progress; finished product; supplies; customer provided
materials or product; product sent for outsourced work; etc, are subject to risk of being
damaged, lost, misused; misplaced; stolen, become unsuitable (perishable) or obsolete
(past shelf life) for use. This could occur during receipt, handling; storage; use in
production; transportation to the customer; etc.
 Controls include – inventory cycle counts; stock rotation methods such as FIFO; just in
time; tracking shelf life; MRP systems for tracking requirements and usage; special, controls
for restricted access; handling and storage of hazardous materials, climate
and environment; identification, status and traceability indicators; maintenance
procedures; bar codes; training; use of special equipment for handling; etc. Also review
specific requirements for preservation and storage at OEM customer or IATF websites.
instructions and other specific documentation. Many of the controls needed for clause 7.5.3
Identification and traceability apply to preservation of product.
preservation of product) may include - reduction in identification errors and omissions;
rejects; waste; scrap; etc., and increase in inventory turnover and material/product
availability; and product safety.
TS16949 Page 93
7.6 Control of Monitoring and Measuring Devices
17:10
7.6 Control of Monitoring and Measuring Devices (MMD)

Determine what monitoring and measurement is required and what MMD devices are
needed to provide evidence of product conformity (see 7.2.1)
Establish processes to ensure that monitoring and measurement can be carried out and is in
fact being carried out in a manner that is consistent with requirements.
When necessary to ensure valid results:
a) Calibrate or verify MMD at specified intervals, or prior to use, against measurement
standards that are traceable to national or international standards. Record the basis for
calibration if no such standard exists.
b) Adjust or re-adjust MMD as necessary
c) Identify MMD so that its calibration status can be determined
d) Safeguard MMD from improper adjustments that would invalidate the measurement
result
e) Protect MMD from damage and deterioration during handling, maintenance and
storage
Assess and record the validity of previous measuring results if when the MMD does not meet
requirements
Take appropriate action on such MMD and any product affected
Keep records of the calibration and verification of MMD’s
Confirm the ability of computer software to satisfy the intended application, when it is used
to measure and monitor to specified requirements. Confirm this ability prior to initial use
and reconfirm as necessary.
Note: See ISO 10012-1 and 10012-2 for guidance
Note: A number or other identifier traceable to the device calibration record meets the
intent of 7.6c.
7.6.1 Measurement System Analysis

Conduct statistical studies to analyze variation present in the results of each type of MMD
that is referenced in the Control Plan.
Use analytical methods & acceptance criteria that:
Conform to methods and criteria in customer reference (MSA) manuals Or use other
methods, if approved by the customer
7.6.2 Calibration/verification Records

Keep records of the calibration or verification of company & employee owned MMD’s to show
evidence of product conformity. These records shall include:
 MMD identification, including the measurement standard used to calibrate the MMD
 Revisions following engineering changes
TS16949 Page 94
 Any out-of-specification readings as received for calibration or verification
 An evaluation of the impact of the out-of-specification condition
 Statement of conformity to the specification after calibration or verification
 Notification to the customer if suspect product or material been shipped
7.6.3 Laboratory Requirements

7.6.3.1 Internal Laboratory
In your QMS documentation, define the scope for your laboratory that includes:
 It’s capability to perform required inspection, test & calibration services
Your laboratory shall specify & implement technical requirements that, as a minimum,
include:
 Adequacy of laboratory procedures
 Competency of laboratory personnel
 Product testing
 Capability to perform these services correctly and be traceable to relevant process
standards (such as ASTM, EN, etc,)
 Review of related quality records
Note – your internal laboratory may be accredited to ISO/IEC 17025, but it is not
mandatory.
7.6.3.2 External/commercial/independent Labs

Where you use an external, commercial or independent laboratory for inspection, test or
calibration services, it shall have a defined laboratory scope that includes its capability to
perform the inspection, test or calibration services you require.
You shall obtain evidence that the external laboratory is:
 Accredited to ISO/IEC 17025 or national equivalent
 OR - that it is acceptable to the customer
Note 1: Evidence of customer acceptance may include an audit by the customer or an audit
by a customer-approved 2nd party that the laboratory meets the intent of ISO/IEC 17025
Note 2: The equipment manufacturer of a specific MMD, can perform its calibration, if a
qualified laboratory is not available. In such cases, you shall ensure that clause 7.6.3.1
requirements are met.

 Requirements for what needs to be measured (see clause 4.1c & e; 7.1c) and the
acceptance criteria (see clause 7.2.1; 7.1c; 7.3.3c) may come from the customer,
regulatory, industry and your own organization. Product realization planning (see clause
7.1) must determine the following – what specific product and process characteristics needs
to be monitored and measured; the criteria for product acceptance; the type of monitoring
and measurement device needed; frequency - at what stages of realization to do it; sample
size; etc.
 You must then determine what MMD is appropriate for each measuring or monitoring
requirement. Consideration must be given to the measurement capability (precision) of the
MMD which may have to be several times greater than the tolerance criteria for product
TS16949 Page 95
measurement. This would depend on the industry you are in and the criticality of end use
for the product (e.g. the precision requirements for an engine block or for ball bearings may
be much greater than say for cutting leather to cover a car seat).
 Personnel using MMD’s must have competence and training in the use of MMD’s in
terms of their function, range and precision of measurement, reliability, use and
maintenance.
 MMD’s may include measurement and testing tools; equipment; hardware and
software. They may be owned by your organization; your employees or the customer.
MMD’s may be used to verify product as well as to measure process conformity (e.g. a
temperature controller on an oven). Besides MMD’s used for product conformity, you may
need to calibrate and control certain MMD’s used in related and peripheral processes such as
production equipment; tooling; maintenance; etc.
 To ensure valid measurement and monitoring results, MMD’s must be controlled.
A process is required, to control the selection; purchase; identification; status; calibration;
use; verification or adjustment; use; handling; maintenance and storage; training;
nonconforming MMD’s; calibration records; etc. Appropriate records need to be kept of the
use of these controls.
 All MMD’s used for product verification must be capable of being calibrated, verified or
both. Calibration is setting or correcting an MMD, usually by adjusting it to match or
conform to a dependably known and traceable standard (e.g. adjusting a micrometer or
caliper to conform to master blocks traceable to national standards).
 Verification is confirming that the MMD is meeting or performing to acceptable national
measurement standards and does not involve any correction or adjustment (e.g. verifying a
ruler or tape measure against a calibrated ruler that has been calibrated to a national
standard). A ruler or tape measure is generally not capable of being calibrated and when it
gets out of calibration its use must be discontinued.
 There are MMD’s that are capable of being both calibrated and verified (e.g. a CMM-
coordinate measuring machine) and may require both to be done in specific situations based
on frequency of use and criticality of measurement. This requirement also applies to the use
of computer software whose calibration status must be established prior to initial use and
reconfirmed (verified) at defined intervals.
 You must define the frequency and method of calibration for each type and level (shop
floor; laboratory or standard) of MMD. Your calibration records must identify what standard
you used for calibration and show traceability of the standards you use at your facility to
national or international standards.
 In rare circumstances, national or international standards may not exist for calibrating
a specific MMD. In such situations consider using industry, manufacturer or even your own
organizational standard to validate the accuracy and reliability of your MMD. Consult with
your customer if the contractual circumstances require it.
 Your control plan must define the measurement and monitoring required and the type
of MMD needed for it, including the frequency of measurement and acceptance criteria. Use
customer reference manuals, such as the Measurement Systems Analysis (MSA) manual, to
conduct statistical studies on MMD’s referenced in your control plans. Ensure that personnel
performing such statistical studies are trained and competent to do so.
 A multitude of software tools are available to manage and control MMD’s including all
the record keeping details required by clause 7.6.2. There are many acceptable methods to
identify MMD’s and their calibration status. The methods you select must consider the
manufacturers recommendations; frequency of use; environment the MMD is used in; etc.
 Where an MMD is found to be out of calibration, you must take appropriate correction
action to contain and re-verify the product affected, to the extent practical. This is in
addition to containing, repair and recalibration of the defective MMD.
 Customer or internal engineering changes may result in a change in product
TS16949 Page 96
measurement, requirements and/or the MMD to be used. These changes would normally be
reflected in your control plan. Ensure that your calibration process shows clear linkage to
your process for change control (clause 7.1.4) and control plan (clause 7.5.1.1).
 The quality of measurement data is subject to variability related to the measuring
device, the measuring process, the operator using the measuring device, the product being
measured, the environment the measurements are made in, etc. The study and control of
the statistical characteristics (bias, repeatability, reproducibility, stability and linearity) that
measure these variables is called Measurement System Analysis (MSA).
 The TS 16949 standard requires that the MMD or category (verniers, calipers, etc.) of
MMD referenced in product Control Plans be subject to statistical analysis. The analysis
methods and acceptance criteria for the statistical characteristics referred to above must
conform to automotive OEM - MSA reference manuals. Other methods and acceptance
criteria may be used if approved by the customer. Also review specific MSA requirements at
OEM customer or IATF websites.
 In many organizations, the internal laboratory may conduct more technical and
comprehensive inspection, testing and calibration using more complex and sensitive
equipment, methods and standards. You must have document the internal laboratory scope;
You must also specify technical requirements for – adequacy of procedures; personnel
training and competency; testing methods; traceability to relevant process standards;
control of test specimens; records needed, etc.
 Your internal laboratory scope must specify the tests, evaluations and calibrations it is
qualified to perform; provide a list of the equipment used to perform these activities; and a
list of the methods, standards, etc., used.
 The procedures used in the laboratory could be established practices; MMD
manufacturer’s reference or user manuals; industry standards, methods and practices;
customer specified methods; and regulatory methods and practices. These procedures
typically address testing methods and standards; identification and traceability; etc. The
need to have a documented laboratory procedure or manual would depend on the scope and
complexity of product testing and inspection.
 OEM customers may have specific competency and training requirements for laboratory
personnel. Refer to OEM websites; IAOB reference material or contact your OEM customer
for the latest requirements.
 If you use an external laboratory, you must have evidence that it is ISO/IEC 17025 (or
national equivalent) accredited or acceptable to the customer. Ensure that the external
laboratory’s ISO/IEC 17025 accreditation is not out of date and its scope includes the
activities you have contracted it to perform. Also review specific external laboratory
 Clause 4.1f requires you to continually improve your processes. Consider using
appropriate performance indicators such as the monthly trends in - the number of out of
calibration MMD’s; or the number of MMD’s past their calibration due date; number of
MMD’s being used and not controlled; etc. Use these indicators to tighten and improve the
effectiveness of your MMD process. If you have significant laboratory activities, it might be
useful to establish similar performance indicators to measure the effectiveness of laboratory
controls.
needed (see clause 4.2.1d. and 7.1b.). You could use a product quality plan; documented
procedure or other combination of specific practices, procedures, documents and methods.
Look at the risks related to your product, processes and resources in determining the extent
of documented controls you need to have (also see clause 4.2.1 notes).
 Performance indicators (to measure the effectiveness of processes that control MMD’s)
may include reduction - in MMD’s found past due for calibration and being used; reduction
TS16949 Page 97
in damaged, uncontrolled and uncalibrated MMD’s being used; reduction in untrained
personnel found using MMD’s; reduction in lost MMD’s; reduction in MMD’s found out of
calibration; no uncertified external laboratories being used; etc.
TS16949 Page 98
8.1 Measurement, Analysis & Improvement
17:11

8 MEASUREMENT, ANALYSIS & IMPROVEMENT
8.1 General
You shall
l Plan & implement monitoring, measurement, analysis, and improvementprocesses to:
a) demonstrate conformity of product
b) ensure conformity of the QMS
c) continually improve the effectiveness of the QMS
Determine applicable methods, including statistical techniques, and the extent of their use
8.1.1 Identification of Statistical Tools

Determine appropriate statistical tools for each process during advance quality planning and
include these in the Control Plan
8.1.2 Knowledge of basic statistical concepts

Your shall understand & use basic statistical concepts such as variation, control (stability),
process capability and over-adjustment, throughout the organization.

 You must plan and implement processes that measure, analyze and improve the health
of your QMS. The focus of these processes must be on product and process conformity and
improving QMS effectiveness. Consider using a variety of methods including statistical
techniques.
 In planning what to track and measure, we should review the quality objectives we
established in clause 5.4.1 and the performance indicators we established for our QMS
processes and activities. You have to be careful not to overwhelm your organization with
objectives as this may cause more frustration than positive results. Prioritize objectives and
performance indicators to focus on meeting customer requirements and key or risk prone
processes.
 Planning of measurement and data analyses processes must consider the methods and
resources (time, manpower, computer, software, statistical tool, etc) needed to collect,
organize and analyze product and QMS performance data.
 Use your APQP reference manual to determine what statistical methods to use for
products and QMS processes and to what extent to use them. Include these methods in
your control plan. Also review specific statistical concepts and tools required at OEM
customer or IATF websites.
 Statistical methods for product development may include – variation analysis;
regression analysis; dependability analysis; and prediction.
 Statistical methods for purchased product may include – histograms and stratification;
Pareto fault analysis; sampling plans; criteria for acceptance statistics.
 Statistical methods to verify product characteristics and process parameters include –
TS16949 Page 99
process capability studies; control charts; Pareto analysis; variation analysis (special cause,
common cause).
 Statistical methods for field analysis include – dependability assessment; Pareto
analysis; traceability analysis; Shainin techniques.
 Statistical methods for monitoring and measuring devices – refer to various techniques
in your customer reference manuals – e.g. Measurement Systems Analysis (MSA) reference
manual.
 Over-adjustment in clause 8.1.2 refers to making process adjustments that are not
statistically appropriate i.e. tampering.
 Define and implement appropriate training and competency requirements for all
personnel using statistical methods, tools and analysis.
 Where the any of the monitoring, measurement and analysis processes are done off-
site (e.g. in large organizations, customer satisfaction feedback may be done at head-
office), your QMS must include the off-site processes within your QMS and ensure that such
processes comply with ISO 9001 requirements. Evidence of the off-site facility’s compliance
may include - a copy of their ISO 9001 certification; results of their internal audits to ISO
9001; auditing the outsourced facility; etc. The expectation is to flow down to the off-site
facility, the relevant ISO 9001requirements
needed (see clause 4.2.1d. and 7.1b.). You could use a product quality plan; documented
procedure or other combination of specific practices, procedures, documents and methods.
Look at the risks related to your product, processes and resources in determining the extent
of documented controls you need to have (also see clause 4.2.1 notes).
 Performance indicators are not needed for this clause as it provides direction for the
application of monitoring and measurement methods and tools indicators for all QMS
processes. However the output of monitoring and measurement methods used within each
QMS process provides useful performance indicators for determining the degree of
conformity of product and QMS to requirements and whether the QMS has been effectively
implemented and maintained.
TS16949 Page 100

8.2.1 Customer Satisfaction
17:11
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction

You shall
Monitor information based on customer perception of whether the organization has met
customer requirements
Determine methods to obtain and use information
Use customer satisfaction as a measure of QMS performance
Note: Consider both internal & external customers
8.2.1.1 Customer Satisfaction - supplemental

You shall monitor customer satisfaction by continually evaluating performance of realization
processes through:
Delivered part quality performance
Customer disruptions including field returns
Delivery schedule performance (including incidents of premium freight)
Customer notification of quality or delivery issues
You shall monitor manufacturing process performance for product quality & process
efficiency, in meeting customer requirements

 Customers are primarily the end users of your product, but also include intermediaries
such as assemblers (internal or external) who integrate your product into theirs, and
dealers and distributors who market and sell your product or the integrated product. You
need to consider feedback from all these customers to determine whether or not you have
met their specified and perceived requirements.
 Customer requirements may relate to the design, manufacture, delivery, servicing, and
customer and technical support of product; QMS; communication and financial
requirements; etc. you must have controls to identify and meet these requirements (see
clauses 7.1 – 7.6).
 The ISO 9000:2005 standard defines customer satisfaction as - the customer’s
perception of the degree to which the customer’s requirements have been fulfilled. The
phrase ‘the degree’ implies the use of a qualitative or quantitative measure that customers
can use to rate to what extent or degree your performance met their expectations and
requirements, e.g. supplier score cards; alpha or numeric rating scales on survey forms;
etc.
 There are many other ways to monitor customer satisfaction feedback (positive and
negative). These may include – customer complaints; direct communications with
customers; questionnaires and surveys; subcontracted collection and analysis of
performance data (see clause 8.4); reports from consumer organizations; reports in various
media; sector and industry studies.
TS16949 Page 101

 You must continually gather information (about these requirements), capable of
being analyzed and evaluated to determine how well you performed them. There are all
kinds of performance indicators for design, manufacture, delivery, etc. Gather information
on these indicators from both the customer as well from internal processes.
 You are expected to have a process that defines your customer satisfaction indicators;
frequency and method of data collection; summarization, review and evaluation of data;
actions to improve, timeline, responsibility and follow-up (see 5.6 management review.
 Many OEM’s and tier 1 suppliers routinely provide feedback on some or all of the
information in clause 8.2.1.1. You must continuously review this customer feedback to
ensure you maintain and improve your customer satisfaction rating. Review specific
requirements for customer satisfaction at OEM customer or IATF websites.
 ‘Delivered part delivery performance’ relates to reduction in PPM defect rates.
‘Customer disruptions’ relate to temporary interruption or shutdown of your customers
production or service operations that was caused by product quality or delivery problems
from your organization.
 ‘Delivery schedule performance’ relates to product or service delivery that is not early
or late, but just in time based on customer scheduling requirements. Premium freight
whether paid by you or the customer to expedite on-time delivery is a non-value added cost
that must be prevented. You are required to track premium freight costs and take corrective
action if it is a significant cost or occurs frequently.
 Automotive OEM’s may impose a temporary halt on shipments from a supplier
experiencing poor quality or delivery performance. You must take corrective action to
eliminate the problems and their causes, followingcustomer prescribed controls and
measures, before you are allowed to resume production and delivery of the customer’s
product. In many cases, third party audit and customer approvals are required to remove
the ‘halt’. Also review specific requirements for customer hold/halt shipment rules and CB
notification at OEM customer or IATF websites.
 You must also consider performance indicators that improve the efficiency of your
manufacturing processes. These may relate to lean manufacturing tools such as – ANDON
procedures; direct run first time quality results; lead time reduction; level scheduling;
number of error-proofing opportunities implemented; planned maintenance; standardized
work; workplace organization and visual controls deployed.
 You must monitor trends in customer satisfaction indicators and use these as a
baseline for continual improvement. You should consider both external as well as internal
customer satisfaction. Note that every internal process is either a customer or supplier of
another process.
 If any or all of your customer satisfaction process activities are done off-site, you must
still identify this as a QMS process and show the interaction with the offsite organization
(head office perhaps) in addressing these requirements and show how customer feedback
information from Head office is used by you for continual improvement and enhancing
customer satisfaction.
 Clause 8.2.1 does not require a ‘documented’ procedure. However, you must identify
and document the process addressing this clause as part of your QMS (see clause 4.1). For
this process, you must also identify what specific documents, controls and resources are
needed (see clause 4.2.1d. and 7.1b.). You could use a documented procedure or other
combination of specific practices, procedures, documents and methods. Look at the risks
and benefits in determining the extent of documented controls you need to have (also see
clause 4.2.1 notes).
customer satisfaction may include – improvement in customer feedback ratings; reduction
in customer complaints; increase in the number of customers providing feedback; increase
in feedback that leads to QMS and product improvement opportunities.
TS16949 Page 102

8.2.2 Internal Audits
17:12
8.2.2 Internal Audit

You shall:
Conduct internal audits of your QMS at planned intervals, to determine if it:
a) - Conforms to planned arrangements (see 7.1);
- Conforms to TS 16949 requirements;
- Conforms to your organizations QMS requirements
b) Is effectively implemented and maintained
Plan and adjust your audit program taking into consideration the:
 status and importance of the processes and areas to be audited
 results of previous audits
Your audit program must:
 Have a documented procedure that defines responsibilities and requirements for:
► Planning and conducting audits
► Reporting of results and maintaining records
 Ensure that management responsible for the area audited takes corrective actions
without undue delay to eliminate detected nonconformities and their causes
 Have follow-up activities that include verifying the actions taken and reporting
verification results (see clause 8.5.2)
 Define the audit criteria, scope, frequency, and methods to be used
 Select auditors and conduct audits in a manner that ensures the objectivity &
impartiality of the audit process. Ensure that auditors do not audit their own work
Note: See ISO 19011 for guidance
8.2.2. QMS Audit

You shall audit your QMS for conformity to TS 16949 & any additional QMS requirements.
8.2.2.2 Manufacturing Process Audit

You shall audit each manufacturing process to determine its effectiveness
8.2.2.3 Product Audit

Conduct product audits at a defined frequency, at appropriate stages of production &
delivery, to verify conformity to all specified requirements such as product dimensions,
functionality, packaging and labeling.
8.2.2.4 Internal Audit Plans

Schedule audits on an annual plan, to cover all QMS processes, activities &shifts
Increase audit frequency when internal/external nonconformities or customer complaints
occur
TS16949 Page 103

Note : Specific checklists should be used for each audit
8.2.2.5 Internal Auditor Qualification

Use internal auditors who are qualified to audit to the requirements of TS 16949

 Internal audit is the second tool to gauge the health of your QMS. You must have
a documented procedure for your internal audit process. Your procedure must address
the following control requirements:
 The scope of your internal audit program must cover:
 Audit of the QMS - to determine conformity to the TS 16949 standard
 Audit of the QMS – to determine conformity to organizational requirements
 Audit of QMS processes and their interaction – to determine if the QMS has
been effectively implemented and maintained.
 Audit of each manufacturing process to determine its effectiveness
 Audit of product across all stages of production and delivery- to determine conformity
to requirements specified by the customer and regulatory bodies.
 All shifts involved in activities affecting product or process quality. Note that there may
be shifts for product realization processes as well as support processes.
 You must adjust the audit frequency (and perhaps even the audit scope), of specific
QMS processes; manufacturing processes; shifts; and products when:
 You experience internal or external nonconformities
 Get customer complaints
 Have critical or high risk processes
 Have frequent or significant changes to processes and product
 OEM customers may also specify the scope, frequency, criteria, responsibility, etc of
internal audits. Review specific requirements at OEM customer or IATF websites.
 Your annual internal audit program should consider the following:
 Input from audited area and related areas
 Key customer oriented processes (see notes to clause 4.1)
 Process and product performance results and expectations
 Analysis of quality cost data (see clause 5.6.1.1; 8.4.1)
 Capability of processes and use of statistical techniques
 Effective and efficient implementation of processes (lean manufacturing techniques)
 Opportunities for continual improvement
 Relationships with customers
 Over the Certification Body’s (or Registrar) audit cycle (3 years), the CB must audit all
of your organization’s processes and their applicable IATF OEM customer-specific
requirements.
 Your internal audit program should be more detailed and exhaustive than the external
CB audit. With this outlook in mind, your internal audit program should consider auditing all
your QMS processes at least once within the CB 3 year audit cycle (preferably once a year)
and some processes more often based on the criteria covered above.
TS16949 Page 104

 The design process (whether onsite of off-site) should be audited at least once within
each consecutive 12 month period. Your internal QMS audit program should include all off-
site processes and subcontract ‘sites’ that support your facility. These audits may be done
by others, such as head office, sister facility or qualified subcontract auditors.
 Audit criteria , refers to the specific QMS policies, objectives; TS requirements;
documentation; customer and regulatory requirements, etc., that the audit is referenced to
or conducted against. Audit criteria may relate to the whole audit program as well as each
individual audit.
 Audit methods refer to the specific techniques that auditors use to gather objective
audit evidence that can be evaluated to determine conformity to audit criteria (see above
paragraph). Examples of audit methods include – interview of personnel, observation of
activities; review of documents and records; etc.
 The qualification/training requirements may vary for the different types of audits
required by this standard. You must define the minimumqualification/training
requirements for internal auditors for each type of audit :
 Personnel performing QMS audits or manufacturing process auditsmust have adequate
training on - the requirements of the TS 16949 standard; training on the automotive
process to auditing; audit practices and audit experience as defined by ISO 19011 and IATF
guidance; QMS processes and their interaction; customer requirements and applicable
regulatory requirements. Also review specific internal auditor training requirements at OEM
 Personnel performing product audits must have training on - production and delivery
processes; audit practices and techniques; product specific customer requirements and
applicable regulatory requirements. Product specific auditors do not necessarily need
training on the requirements of the TS 16949 Standard.
 You must have appropriate resources to carry out your annual audit program. These
include - having sufficient trained auditors available to conduct scheduled audits; sufficient
time to perform audits; availability of process personnel to be audited; time and tools to
prepare audit records and reports; etc.
 Auditor Independence - Auditors can audit their own department provided their
objectivity and impartiality is not compromised, but they cannot audit their own work. You
must ensure auditor independence when assigning personnel to specific audits.
 Process owners must take timely corrective action on nonconformities found in their
area. They should use the corrective action procedure (clause 8.5.2) to determine root
cause, take action and follow-up to determine if results indicate that the root cause has
been eliminated.
 Audit results must be summarized and reported for management review (see clause
5.6.2). The Management Representative must also report any opportunities for QMS
improvement (see clause 5.5.2b. The MR must analyze the results of each audit as well as
the annual audit program to determine strengths and weaknesses in QMS processes,
interactions, functions, products, etc., to identify and prioritize opportunities for
improvement.
 Audit records include – annual audit schedule; audit planning- (criteria, scope,
frequency, methods, auditor selection and assignment, etc); auditor competence and
training; audit checklists and forms; audit notes and other evidence gathered; audit
findings; nonconformity reports; audit reports; corrective actions and follow-up of internal
audit nonconformities; analysis of audit program performance indicators and trends; and
identified improvement opportunities.
 You should be aware that the Certification Body (CB) is required to audit your
organization using the process approach and each site audit by the CB must include:
 Implementation of requirements of new customers since the last audit
TS16949 Page 105

 Customer complaints and organizational response
 Your internal audit and management review results and subsequent actions
 Progress made towards continual improvement targets
 Effectiveness of the corrective actions and verification since the last audit
 Effectiveness of the QMS in achieving both organizational and customer objectives
 Like all QMS processes (see clause 4.1), you must have
performanceobjectives (indicators) to measure the effectiveness of your internal audit
process and monitor trends in these indicators, to continually improve your audit
program. Performance indicators may include reducing the number of - late or delayed
audits; incomplete audits; incomplete audit records and late reports; auditor errors; auditee
complaints; and use of untrained auditors; etc.
 The output of the TS 16949 internal audit program may be used as performance
indicators to:
 Determine the degree of conformity of the QMS to TS 16949; customer and regulatory
requirements.
 Determine the effectiveness of QMS implementation and maintenance.
 Determine the degree of conformity of product to contractual and regulatory
requirements.
 Identify areas of the QMS that need improvement.
TS16949 Page 106

8.2.3 Monitoring and Measurement of Processes
17:12
8.2.3 Monitoring and Measurement of Processes

You shall:
Apply suitable methods for monitoring, and where applicable, measurement of QMS
processes (see 4.1)
These methods shall demonstrate the ability of QMS processes to achieve planned results
(see 4.1)
If planned results are not achieved, take correction and corrective action to ensure product
conformity
8.2.3.1 Monitoring and Measurement of Manufacturing Processes

Perform process studies of all new manufacturing (including assembly and sequencing)
processes) to verify process capability & to provide additional input for process control
Document the results of process studies with specifications (where applicable) for
production, measurement, test & maintenance instructions
These documents shall include objectives for manufacturing process capability, reliability,
maintainability & availability, as well as acceptance criteria
Maintain manufacturing process capability or performance as specified by the customer part
approval requirements
Implement Control Plans & process flow diagram to ensure conformity to specified:
 Measurement techniques,
 Sampling plans,
 Acceptance criteria and
 Reaction plans when criteria not met
Keep a record of significant process events such as tool change, machine repair, etc.
Initiate reaction plans from the Control Plan, for characteristics that are either unstable or
not statistically capable.
These reaction plans shall include containment of product and 100% inspection, as
appropriate
Then complete a corrective action plan indicating timing and assigned responsibilities to
assure that the process becomes stable and capable. If required, review these plans with
the customer and get their approval.
Keep records of effective dates of process changes

 You must establish methods and indicators to monitor and measure your QMS
processes (see clause 4.1e and 5.4.1) to demonstrate process capability to achieve planned
results and identify opportunities to improve the process. Use your organizations cross-
functional knowledge of customer requirements; product; technology; manufacturing
processes; etc, to determine process monitoring and measuring indicators and controls.
TS16949 Page 107

Monitoring and measurement may be done manually or by automated means.
 One way to identify useful measuring and monitoring methods is to review what
problems could occur or have occurred within a particular process. Monitor and measure
these occurrences and develop process controls (methods) to reduce or eliminate them.
Problems (risks) can occur with any of the variables in a process – e.g. – materials;
equipment; facility; methods; technology; personnel; computer hardware or software; etc.
By using fishbone analysis or similar tools, you can develop very useful monitoring and
measuring methods and process performance indicators.
 Correction refers to action taken to eliminate a detected nonconformity (see clause
8.3). Correction involves the containment, evaluation of the nonconformity and action that
may result in rework; regrade; scrap; return of nonconforming material/work to supplier or
outsourcer; or acceptance through a customer concession or deviation permit.
 Correction differs from corrective action (clause 8.5.2). Corrective action is action
taken to eliminate the cause of a detected nonconformity to prevent recurrence; whereas
correction does not address cause.
 You must monitor your manufacturing QMS processes, first to determine and establish
capability of new processes to conform to requirements
 And secondly, to monitor these processes over time to verify ongoing stability and
capability to meet requirements
 And thirdly to determine and achieve levels of continual improvement
 Use your APQP, FMEA, MSA and PPAP reference manuals for guidance in determining
process monitoring and measuring indicators and controls.Also review specific measurement
and monitoring requirements at OEM customer or IATF websites.
 The output of your manufacturing process design process (clause 7.3.3.2 and 7.3.2.2)
must specify the manufacturing process capability, reliability, maintainability & availability
indicators, as well as process approval acceptance criteria
 Your manufacturing process capability performance must conform to the capability
documented in your PPAP submission or agreed with your customer in writing. You must
keep records of this ongoing conformance to your customer requirements and use this
information to identify opportunities to improve the process.
 The measurement techniques, sampling plans, acceptance criteria and reaction plans
must be documented or referenced in your control plan. Managers responsible for
corrective action must be promptly informed of product and process nonconformities (see
clause 5.5.1.1). Also review specific sampling plan requirements at OEM customer or IATF
websites.
 Where the customer is significantly affected by a process nonconformity or change,
they must be notified. Corrective action plans as well as resulting updated/changed PPAP’s
must be reviewed and approved by the customer, when so required. If in doubt, get
clarification from the customer.
 Use your manufacturing design process (clause 7.3) and change control process
(clause 7.1.4) to manage manufacturing process changes.
 Performance indicators are not needed for this clause as it provides direction for the
application of monitoring and measurement performance indicators for all QMS processes.
However the output of monitoring and measurement methods used within each QMS
process provides useful performance indicators for determining the effective implementation
and maintenance of QMS processes. Review the performance indicators within each process
covered this far.
 Performance indicators to measure process effectiveness and efficiency
include - productivity; reduction of cycle time, waste, errors, omissions and failures; asset
utilization rates (downtime, turnover), etc.
TS16949 Page 108

 Don’t overlook performance indicators to measure compliance with process related
regulatory requirements – e.g., reduction in health and safety incident/violation rates;
reduction in regulatory reporting violations, etc.
TS16949 Page 109

8.2.4 Monitoring and Measurement of Product
17:13
8.2.4 Monitoring and Measurement of Product

You shall:
Monitor and measure product characteristics to verify that product requirements have been
met
Carry this out at appropriate stages of product realization as per planned arrangements (see
clause 7.1)
Maintain evidence of conformity with acceptance criteria
Keep records of person(s) authorizing release of product
Do not release or delivery product until all planned arrangements (see 7.1) have been
satisfactorily completed, unless otherwise approved by a relevant authority, and where
applicable by the customer.
Note: Consider type of product characteristics, (when selecting product parameters to
monitor conformity to internal and external requirements). These should lead to types of
measurements, suitable means of measurement and capability & skills required,
8.2.4.1 Layout Inspection

You shall perform a layout inspection & functional verification for each product, to applicable
customer engineering material & performance standards, as specified in the Control Plans.
Keep results available for customer review
8.2.4.2 Appearance Items

For parts designated by the customer as appearance items, you shall provide:
Appropriate resources including lighting for evaluation
Masters for color, grain, gloss, metallic brilliance, texture, distinctiveness of image, as
appropriate
Maintenance & control of appearance masters & evaluation equipment
Verification of the competence and qualifications of personnel performing appearance
evaluations

 to determine process monitoring and measuring indicators and controls. Monitoring and
measurement may be done manually or by automated means.
 You must identify, monitor and measure product characteristics to verify conformity to
requirements. Product characteristics may include - dimensional; functional; performance;
reliability; durability; maintainability; life; cost; etc. We had previously established that
requirements may come from your customer, your own organization, regulatory and
industry sources. Also review specific product test and monitoring requirements at OEM
 You must plan (see clause 7.1) – what product characteristic(s) to measure; type of
measurements; what measurement device to use; how often to measure; sample size;
acceptance criteria; and records needed - for each product or product type. Your planning
TS16949 Page 110

must include all special and safety characteristics specified by the customer, your own
organization, regulatory and industry sources. Also review specific sample size
 Use your APQP process (use product design, see clause 7.3.3 and 7.3.3.1); customer
and applicable regulatory requirements; and cross-functional knowledge of - customer
requirements, product technology, manufacturing processes; etc., to determine product
acceptance criteria; types of measurement; related monitoring and measurement controls;
and capability and skills required to perform these monitoring and measurement controls.
 Your control plan must define the stages that various monitoring and measurement
controls will be carried out – incoming receipt of materials from suppliers or outsourced
work; storage; internal production processes; finished product; packaging; at time of
shipping; and post installation.
 Monitoring and measurement may be done by your personnel, subcontracted or
outsourced labor or by the customer. You must ensure that all personnel performing
monitoring and measurement of product are trained and competent.
 If you plan on releasing (during any stage of production) or shipping finished product,
where all planned inspections and measurements to that stage have not been completed,
ensure that you obtain prior written approval/waiver from a relevant internal authority or
the customer (see clause 8.3.4). Where practical, consider completing all missed planned
inspections and measurements before product delivery.
 Layout inspection is the complete measurement of all product dimensions shown on
the design record. Refer to your specific customer requirements and PPAP reference manual
for guidance on frequency and process for doing layout inspection and functional testing.
Ensure you use the correct customer engineering material and performance standards for
each product. Keep all records for customer review and/or submit for approval if
required. Review specific layout requirements at OEM customer or IATF websites.
 Clarify (using your APQP process) up-front during contract negotiations or during
design and development whether the product is designated as an ‘appearance item’.
Resources for controlling appearance items may include - special equipment and supplies;
lighting; environmentally controlled space or laboratory; competent and trained personnel;
appearance standards or masters (provided by the customer; industry or developed by your
own organization); use of special testing and measurement devices and their calibration;
etc.
 Your process for ‘appearance items’ must define and control all of these variables as
applicable. In the event of an ‘appearance item’ product nonconformity, clarify with your
customer, the rules for repair and rework. Review specific appearance items requirements
 Clause 8.2.4 does not require a ‘documented’ procedure. However, you must identify
and document all product realization processes that may address this clause, as part of your
QMS (see clause 4.1), e.g. receiving, production, shipping, etc.. For such processes, you
must also identify what specific documents are needed (see clause 4.2.1d. and 7.1b.) for
effective planning, operation and control.
 You could use a product control plan; documented procedure or other combination of
specific practices, procedures, documents and methods. Look at the risks related to your
product, processes and resources in determining the extent of documented controls you
need to have (also see clause 4.2.1 notes).
 Performance indicators to measure product conformity - reduction in defect rates,
PPM’s (defective parts per million), scrap rates, waste, rework; improvement in on time
delivery (see clause 7.1a); product returns from customer; etc.
 Don’t overlook performance indicators to measure compliance withproduct related
regulatory requirements – e.g., reduction in product test and product performance failures
to regulatory or industry criteria.
TS16949 Page 111

8.3 Control of Non‐conforming Product
17:13
8.3 Control of nonconforming product

You shall:
Identify and control nonconforming product to prevent its unintended use or delivery
Have a documented procedure to define the controls and related responsibilities and
authorities to deal with nonconforming product. Nonconforming product must be dealt with
in one or more of the following ways:
a) take action to eliminate the nonconformity
b) authorize its use, release, acceptance (under concession) by a relevant authority or
where applicable by the customer
c) take action to preclude its original intended use or application
Maintain records of the nature of the nonconformity and any subsequentactions (and
concessions obtained)
Verify corrected product to show conformity to requirements
When nonconforming product is detected after delivery or use has started, take action
appropriate to the effects (or potential effects) of the nonconformity.
8.3.1 Control of N/C product - Supplemental

You shall classify unidentified or suspect product as nonconforming product
8.3.2 Control of reworked product

Rework instructions including re-inspection requirements shall be accessible & used by
appropriate personnel
8.3.3 Customer Information

Notify customers promptly if nonconforming product has been shipped
8.3.4 Customer Waiver

When your product or manufacturing process is different from that currently approved, then
you shall obtain a customer concession or deviation permit prior to further processing.
 Keep a record of expiry date & quantity authorized by each concession or permit
 Revert back to compliance with the original or superceding specification, when the
customer authorization expires
 Properly identify each container of material shipped on an authorization. This also
applies to purchased product
 Approve any requests from your suppliers before submission to your customers

 Nonconforming product is defined as product that does not conform to customer
requirements; applicable regulatory requirements or your own organization requirements.
TS16949 Page 112

The definition may also apply to nonconforming processes and services. Nonconformities
may relate to suppliers and outsourced work; your own organizational activities or product
shipped to customers. Also review specific nonconforming product requirements at OEM
 The controls under clause focus on eliminating the nonconformity, but not the cause.
Eliminating the cause is addressed under clause 8.5.2. Your documented procedure for
nonconforming product must include controls and responsibilities to – identify; contain
it,(i.e. prevent further processing or use); keep records of the nature and other details of
the nonconformity; notify appropriate personnel (see clause 5.5.1.1) and customers, where
appropriate; evaluate what disposition action needs to be taken; carry out timely
disposition; determine policies for release for further processing or shipment to the
customer; obtain customer concessions and deviation permits; rework and re-verification;
waivers and approvals of supplier materials, etc.
 Product or material found with no identification or its quality status is not known, must
be treated as nonconforming product and controlled by the above procedure.
 If you find that nonconforming product has been shipped, without a customer
concession, notify the customer immediately and use your procedure, to effectively contain
and resolve the situation to your customer’s satisfaction. Where required, use the customer
prescribed form for recording and controlling nonconforming product.
 An authorization refers to written permission (number or code) to ship or manufacture
nonconforming product. The permission is usually very specific about product, quantity and
time frame during which nonconforming product can be shipped. The authorization number
or code must identify each container shipped under the authorization.
 A concession authorization allows you to ship nonconforming product, under controlled
conditions. A deviation authorization allows you tomanufacture product different from the
original specification, under controlled conditions. Also review specific waiver requirements
 Ensure that all rework has evidence of re-inspection after the rework has been done
and that the personnel doing the rework and re-inspection have been trained (keep records
of training) and are using the rework instructions.
 All customer-oriented processes (see clause 4.1) must show the interaction with your
process for nonconforming product.
 Performance indicators to measure the effectiveness of control of nonconforming
product may include – reduction in cycle time to evaluate and dispose of nonconforming
product; reduced errors in preventing unintended use or delivery; improved alternate use of
nonconforming product and cost recovery; etc.
TS16949 Page 113

8.4 Analysis of Data
17:13
8.4 Analysis of Data

You shall:
Determine, collect, and analyze appropriate data (from monitoring and measuring activities
as well as other relevant sources) to:
Demonstrate the suitability and effectiveness of your QMS and to identify opportunities to
continually improve its effectiveness
Analyze data to provide information relating to:
 customer satisfaction
 conformity to product requirements
 characteristics and trends of processes and product (including opportunities for
preventive action)
 suppliers
8.4.1 Analysis and use of data

You shall compare trends in quality & operational performance with progress towards
objectives, leading to action that:
 Prioritizes and promptly solves customer-related problems
 Determines key customer related trends to support status review, decision making
and longer term planning
 Enables an information system for timely reporting of product usage
Note: Compare data with competitor and/or appropriate benchmarks

 It is amazing how many organizations have wonderful systems for collecting data, but
do a poor job in sorting, summarizing and presenting this data for decision-making. You
must sort and summarize the data you collect into TGR and TGW (things gone right and
things gone wrong) and present them separately. Management can then focus on continual
improvement of TGR and take corrective action on TGW.
 You must collect and analyze QMS data that relate to the effectiveness and efficiency of
products; services; QMS processes; production output; supplier performance; use of
resources; cost of poor quality; customer satisfaction; etc. Do year over year trend analysis
to determine longer-term progress, identify opportunities for further improvement or
prioritize correction action for negative trends.
 Your process for data collection and analysis must address the type of data to be
collected; how it should be sorted and classified (remember TGR and TGW); use of
appropriate information systems and data gathering tools and techniques; assignment of
responsibility and authority to review and act; competency and training in use of tools and
data analysis; that the data is gathered, analyzed and acted upon on a timely basis. A
summary of QMS performance data must be included in your periodic management review
TS16949 Page 114

(see clause 5.6).
 Compare trends in quality and operational performance against your business plans;
competitors and industry benchmarks, where practical. Focus on key customer-related
trends to prioritize prompt solutions to problems; to determine longer-term planning for
performance improvement; and to enhance customer satisfaction.
 Performance indicators to measure the effectiveness of processes for data collection
and analysis may include – reduction in cycle time to gather and evaluate data; reduction in
inaccurate and incomplete data; increase in improvement opportunities obtained from data
analysis; etc.
TS16949 Page 115

8.5.1 Continual Improvement
17:14
8.5 Improvement
8.5.1 Continual Improvement
You shall continually improve the effectiveness of your QMS through the use of:
- Quality policy and quality objectives
- Audit results
- Analysis of data
- Corrective and preventive actions
- Management review
8.5.1.1 Continual Improvement of the Organization
l You shall define a process for continual improvement (see examples in annex B of ISO
9004:2000)
8.5.1.2 Manufacturing Process Improvement

l You shall continually focus on controlling & reducing variation in product characteristics
& manufacturing process parameters
Note 1 : Controlled characteristics are documented in the Control Plan
Note 2 : Continual improvement is implemented once manufacturing processes are capable

and stable or product characteristics are predictable and meet customer requirements

 The focus of this clause is on continual improvement of the QMS and not on product.
Continual improvement of product is addressed in clause 5.6.3b. and 7.1a.
 Under ISO 9000:2000, continual improvement is defined as a recurring activity to
increase the ability to fulfill requirements. The ‘ability to fulfill requirements’ refers to both
conforming as well as nonconforming processes. Conforming processes can be further
improved; and nonconforming processes must be improved by taking corrective action to
prevent recurrence. Recurring activity refers to the quality improvements listed in clause
8.5.1 – quality policy and objectives; audit results; analyses of data; etc.
 TS 16949 takes a different stance. Continual improvement is only applicable to
processes that are stable and capable (i.e. under control or conforming). It cannot be
applied to nonconforming processes. Corrective action must first be taken to bring
nonconforming (unstable or non-capable) processes under control, before any continual
improvement can be done.
 The continual improvement process can be conducted by:
 Significant breakthrough projects that either revise or improve existing processes or
lead to new processes. These are usually done by cross-functional teams outside routine
operations.
 Small-step ongoing improvement activities conducted by personnel within existing
processes.
Use of continual improvement tools listed in clause 8.5.1, include:
TS16949 Page 116

 Quality Policy - if you recall clause 5.1 required top management to establish the
quality policy and clause 5.3.e required them to review it for continuing suitability. Changes
in product, customer base, organization ownership, management, technology, QMS
standards, etc., may require changes to your quality policy and objectives. As a tool for
continual improvement, it requires top management to review and understand these
changes; make changes, if necessary, to the quality policy and objectives and use these
changes to continue further improvement of the QMS and customer satisfaction.
 Audit Results - Results of product, process, process and QMS audits usually provide
many opportunities to improve QMS effectiveness and efficiency. Opportunities may relate
to communications; information systems; processes; controls; use of resources;
technology; etc. The management representative must report these opportunities to top
management as included as part of the management review agenda. They can also be
reported and reviewed at regular operational meetings, etc.
 Other Audits - Besides product, process and QMS audits, you might find it very
productive to conduct financial; health and safety; environmental; technology; product
profitability; social responsibility; information and communication systems audits. You will
be amazed at what you will find and improvement opportunities you will uncover.
 In using ‘analyses of data’ as a tool for continual improvement, use the TGR and TGW
approach discussed in clause 8.4 to classify your data for decision-making.
 Examples of situations which might lead to improvement projects include: machine set-
up, die change, machine changeover times; cycle time; scrap; non value-added use of floor
space; variation in product characteristics and process parameters; less than 100% first run
capability; process averages not centered on target values; testing requirements not
justified by accumulated results; waste of labor and materials; difficult manufacture,
assembly and installation of product; excessive handling and storage; etc.
 Other tools that are often used to continually improve, include: capability studies;
design of experiments; evaluation procedure; quality control chart system; risk analysis;
SPC; supplier evaluation; test and measurement technology; theory of constraints; overall
equipment effectiveness; parts per million (ppm) to achieve zero defects; value analysis;
benchmarking; analysis of motion/ergonomics and error-proofing. Ensure that personnel
applying these tools are competent and trained.
 Use SPC, new material, tooling, equipment or technology to control and reduce
variation in product characteristics and process parameters. Document improvements in
drawings, FMEA, control plans, work instructions, etc., and update PPAP.
 Performance indicators to measure the effectiveness of the continual improvement
process may include – quality objectives being met sooner than planned;; achieving and
exceeding business and quality objectives; improved efficiency in use of resources; cost
reduction; improved product quality; increased Cpk’s; etc.
TS16949 Page 117

8.5.2 Corrective Action
17:14
8.5.2 Corrective Action

You shall
Take action to eliminate the cause of nonconformities in order to prevent their recurrence
Take action appropriate to the effects of the nonconformities encountered
Define requirements in a documented procedure to:
a) review nonconformities (including customer complaints)
b) determine the causes of nonconformities
c) evaluate the need for action to ensure that nonconformities do not re-occur.
d) determine and implement corrective action needed
e) record the results of actions taken
f) review corrective action taken
8.5.2.1 Problem Solving

l You shall have a defined process for problem solving leading to root cause identification
& elimination. Use customer prescribed problem-solving format, where available
8.5.2.2 Error-proofing
You shall use error-proofing methods in your corrective action process
8.5.2.3 Corrective Action Impact

You shall apply the corrective action and controls you implemented to eliminate the cause of
nonconformity, to other similar products & processes.
8.5.2.4 Rejected Products test/analysis

You shall:
Analyze parts rejected by customers plant, engineering facilities and dealerships
Initiate corrective action to prevent recurrence
Minimize the cycle time of this process
Keep records of these analyses and make them available to customers on request
Note: Cycle time for product analysis should be consistent with determining root cause,
corrective action and monitoring effectiveness of implementation

 Corrective action is action taken to eliminate the cause of a detectednonconformity
to prevent recurrence, whereas preventive action is action taken to eliminate the cause of
a potential nonconformity or other undesirable situation, to prevent occurrence.
 You must have a documented procedure for your corrective action process which
must address the following control requirements:
 Identify detected nonconformities that relate to your - products; QMS processes;
TS16949 Page 118

resources; suppliers and outsourced work; product shipped to customers; customer
complaints; cost of quality reports; and TGR (things gone wrong) reports.
 Define your process for identifying and using appropriate problem-solving
tools to determine the underlying root cause(s) of the nonconformity Use the customer
prescribed problem-solving format (e.g. 8D form), where available. Review specific tools,
methods and requirements at OEM customer or IATF websites.
 Problem-solving tools may include - analysis of failure mode; capability studies;
correlation diagrams; data collection; fishbone diagram (Ishikawa diagram); FMEA review;
histograms; Pareto analysis; probability charts; stratification of data; graphic
representations; etc. Ensure that personnel applying these tools are competent and
trained.
 Do a Pareto analysis of the root causes of all your corrective actions by type,
process, product, etc to prioritize problem-solving resources and applying lessons learned.
Also, consider doing a Pareto analysis of cost of poor quality data to prioritize corrective
action. Top management understand dollars a whole lot more than numbers!
 Actions taken to eliminate the cause of nonconformity must flow from your
problem-solving activity. Actions may involve changes to product, process, resources,
documentation, controls, etc or any combination of these. Conduct tests to determine
whether these actions have indeed eliminated the cause(s) of the nonconformity and
prevented recurrence. You must keep appropriate records of these actions and follow-up
activities
 You must monitor your corrective action records on an ongoing basis, for any
recurrence of the nonconformity, you took corrective action on. If you found that the
problem has occurred again, then perhaps your analysis of root cause may have been
incorrect or incomplete.
 Apply successful corrective action solutions to other similar
products , processes and sites where there may be the potential for the same
nonconformity to occur. Use error-proofing methods across similar products, processes and
sites, wherever cost effective and feasible, to prevent recurrence or avoid occurrence of
nonconformity.
 Analyze and take corrective action on product rejected by your
customer’s manufacturing plants, engineering facilities and dealerships. Minimize the cycle
time for both – rejected product analysis and related corrective action.
 Keep appropriate records of all corrective action steps. Ensure timely
completion of any open corrective action or be prepared to provide evidence to justify its
continued open status. Make your corrective action records available on request to
customers and provide asummary report for management review.
 All nonconformities may not necessarily result in corrective action. Evaluate the
significance of nonconformities in terms of their impact on - operating costs; cost of
nonconformity and its correction; frequency of occurrence; product performance; process
capability; process variation; dependability; safety; regulatory requirements; affect on
customers product and processes; any other risks; and customer satisfaction. Consider
using cross-functional teams in such decision-making, including the involvement of your
organizations designated customer representative (see clause 5.5.2.1).
 Performance indicators to measure the effectiveness of the corrective action process
may include - reduction in cycle time for correction actions, problem re-occurrence, open
corrective actions, cost of poor quality; and improvement in QMS productivity.
TS16949 Page 119

8.5.3 Preventive Action
17:14
8.5.3 Preventive Action

You shall:
l Determine action to eliminate causes of potential nonconformities to prevent their
occurrence
l Preventive action must be appropriate to the effects of the potential problems
l Define requirements in a documented procedure to:
a) determine potential nonconformities and their causes
b) evaluate the need for action to prevent occurrence of nonconformities
c) determine and implement the needed action
d) record the results of action taken
e) review the preventive action taken

 Corrective action is action taken to eliminate the cause of a detected nonconformity
to prevent recurrence, whereas preventive action is action taken to eliminate the cause of
a potential nonconformity or other undesirable situation, to prevent occurrence.
 Sources of information for finding potential QMS nonconformities include – analyses
of data (see clause 8.4); audit results; cost of quality reports; quality records; service
reports; supplier performance; customer satisfaction feedback; FMEA’s; management
review records; lessons learned from past experience; SPC charts and analyses.
 You must have a documented procedure for your preventive action process which
must address basically all of the explanation points and tips covered under the corrective
action process.
 While preventing potential QMS nonconformities is our focus for ISO 9000 and TS
16949, it might be very useful to think of preventive action in a wider context, i.e. the
entire business. Think in terms of actions needed to prevent – loss of market share; loss of
product profitability; loss due to lack of product diversity; loss of business opportunities due
to lack of capacity, inadequate or older facilities, production equipment, technology or
information systems; loss of key or competent personnel; inadequate business financing;
inadequate staffing, etc.
 These issues may have far more serious consequences than QMS issues. Consider a
process that involves developing a business plan covering these issues, based on -
gathering relevant research data on these issues; use of appropriate risk evaluation and
management methods; developing proactive strategies and action; monitoring and
reviewing performance against the business plan. This would constitute the ultimate
preventive action process.
 Consider using a Pareto analysis to organize and rank the dollar value impact of the
data on the issues listed above in order to:
TS16949 Page 120

 Determine the magnitude of risks and effects on the organization and
 Prioritize preventive on these issues as they are all important and may need significant
amounts of resources to address them.
 Performance indicators to measure the effectiveness of the preventive action process
may include - reduction in cycle time for preventive actions, problem re-occurrence, open
preventive actions, costs; and improvement in QMS productivity.
TS16949 Page 121

Annex A ‐ Control Plan
17:15

Annex A
Control Plan
A 1 Phases of the Control Plan

The Control Plan must cover three distinct phases as appropriate.
a) Prototype: a description of the dimensional measurements, material and performance
tests that will take place during the building of the prototype. You must have a prototype
Control Plan if required by the customer.
b) Pre-launch: a description of the dimensional measurements, material and performance
tests that will take place after prototype and before full production. Pre-launch is defined as
a production phase in the product realization process, which may be required after
prototype build.
c) Production: documentation of product/process characteristics, process controls, tests
and measurement systems that take place during mass production
Each part must have a Control Plan, but in many cases, family Control Plans may cover a
number of similar parts produced using a common process. Control Plans are an output of
the quality plan.
A 2 Elements of the Control Plan
You must develop a Control Plan that includes as a minimum, the following information:
a) General data
 Control plan number
 Issue date, and revision dat, if any
 Customer information (see customer requirements)
 Organization’s name/site designation
 Part number(s)
 Part name/designation
 Engineering change level
 Phase covered – (prototype; pre-launch or production)
 Key contact
 Part/process step number
 Process name/operation description
b) Product Control
 Product related special characteristics
 Other characteristics for control (number, process or product)
 Specification/tolerance
c) Process Control
 Process parameters
TS16949 Page 122

 Process-related special characteristics
 Machines, jigs, fixtures, tools for manufacturing
d) Methods
 Evaluation measurement technique
 Error-proofing
 Sample size and frequency
 Control method
e) Reaction Plan and Corrective Actions
 Reaction plan ( include or reference)
 Corrective action
TS16949 Page 123

Ts 16949

Diunggah oleh

Informasi Dokumen

Hak Cipta

Format Tersedia

Bagikan dokumen Ini

Bagikan atau Tanam Dokumen

Opsi Berbagi

Apakah menurut Anda dokumen ini bermanfaat?

Apakah konten ini tidak pantas?

Hak Cipta:

Format Tersedia

Ts 16949

Diunggah oleh

Hak Cipta:

Format Tersedia

Preface

Source for all information:

Understanding The ISO/TS 16949:2002 Standard

Particular requirements for applying ISO 9001:2000 to automotive

Understanding The ISO/TS 16949:2002 Standard

Key Explanation Points and Tips:

Principle 3 — Involvement of People

Principle 4 — Process Approach

Principle 5 — System Approach to Management

Principle 6 — Continual Improvement

Principle 7 — Factual approach to decision making

Principle 8 — Mutually beneficial supplier relationships

Understanding The ISO/TS 16949:2002 Standard

Key Explanation Points and Tips:

Understanding The ISO/TS 16949:2002 Standard

 All processes must meet (customer, organizational and applicable regulatory)

 An organization’s processes may be grouped or categorized in manyways. One logical

0.2 Process Approach (Continued)

Key Explanation Points and Tips: Process Approach

 Interactions between processes generally have the following characteristics:

 What is being communicated; who is communicating it; who is receiving

 The controls should address the method of interaction or communication; its

Understanding The ISO/TS 16949:2002 Standard

Key Explanation Points and Tips:

 Maintenance and continual improvement of QMS processes can be achieved by

 (PLAN) - For each QMS process you must establish:

 Process owner and his/her accountability

 Process inputs, outputs, value adding or conversion activities and

 Process policies, responsibilities and accountability.

 Process objectives and performance indicators and methods to monitor and

 Resources needed (e.g. facility, equipment, labor, materials, time, etc).

 Process documentation (e.g. procedures, forms, work instructions, specification,

 As mentioned above PDCA is a dynamic cycle and so continual improvement must be

Understanding The ISO/TS 16949:2002 Standard

Understanding The ISO/TS 16949:2002 Standard

0.3.1 IATF Guidance to ISO/TS 16949:2002

Key Explanation Points and Tips:

 The eight quality management principles referred to in the note were

0.5 Goal of ISO/TS 16949:2002

Key Explanation Points and Tips:

Understanding The ISO/TS 16949:2002 Standard

This Standard in conjunction with ISO 9001:

Key Explanation Points and Tips:

Understanding The ISO/TS 16949:2002 Standard

Key Explanation Points and Tips:

Understanding The ISO/TS 16949:2002 Standard

Key Explanation Points and Tips:

Understanding The ISO/TS 16949:2002 Standard

3.1 Terms and Definitions for the automotive industry

3.1.1 Control plan

3.1.2 Design responsible organization

organization with authority to establish a new, or change an existing product specification.

3.1.3 Error proofing

3.1.5 Laboratory scope

controlled document containing the following:

process of making or fabricating :

activities based on process data aimed at the avoidance of maintenance problems by

3.1.8 Preventive maintenance

planned action to eliminate causes of equipment failure and unscheduled interruptions to

3.1.9 Premium freight

extra costs or charges incurred additional to contracted delivery.

NOTE Caused by method, quantity, unscheduled or late deliveries.

3.1.10 Remote location

location that supports sites and at which non-production processes occur.