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Gap Analysis Report Summary

This reference is a quick clause-by-clause summary of the ISO 9001:2008 requirements.


Note: See the actual standard along with the Gap Analysis Checklist for a complete description of the requirements.
ISO 9001:2008 Summary of Requirements

4. Quality Management System


4.1 General Requirements Implement quality system and continually improve it
4.2 Documentation Requirements
4.2.1 General Include the required documents and records
4.2.2 Quality Manual Establish and maintain a quality manual
4.2.3 Control of Documents Ensure documents are at right status in right places
4.2.4 Control of Records Identify records and keep as evidence of conformity
5. Management Responsibility
5.1 Management Commitment Show evidence of top management commitment
5.2 Customer Focus Meet the requirements and satisfy your customers
5.3 Quality Policy Have top management express quality intentions
5.4 Planning
5.4.1 Quality Objectives Set measurable targets for products and processes
5.4.2 Quality Management System Planning Carry out plans for quality system and its processes
5.5 Responsibility, Authority, and Communication
5.5.1 Responsibility and Authority Make sure everyone knows their duties and roles
5.5.2 Management Representative Appoint a manager as focal point for quality system
5.5.3 Internal Communications Keep everyone informed of system effectiveness
5.6 Management Review
5.6.1 General Review the quality system at planned intervals
5.6.2 Review Input Ensure the required agenda topics are covered
5.6.3 Review Output Record the decisions and actions from reviews
6. Resource Management
6.1 Provision of Resources Provide necessary resources to meet requirements
6.2 Human Resources
6.2.1 General Ensure everyone working in system is competent
6.2.2 Competence, Training, and Awareness Train personnel and recognize their contributions
6.3 Infrastructure Provide facilities, equipment, and support services
6.4 Work Environment Manage combination of human and physical factors
7. Product Realization
7.1 Planning of Product Realization Plan and develop processes for product realization
7.2 Customer-Related Processes
7.2.1 Determination of Product Requirements Define customer, regulatory, and own requirements
7.2.2 Review of Product Requirements Review requirements before committing to customer
7.2.3 Customer Communication Talk to customers about products and complaints
7.3 Design and Development
Gap Analysis Report Summary
ISO 9001:2008 Summary of Requirements

7.3.1 Design and Development Planning Plan design stages, activities, and responsibilities
7.3.2 Design and Development Inputs Identify and review input requirements for design
7.3.3 Design and Development Outputs Prepare design outputs and approve before release
7.3.4 Design and Development Review Review ability of design results to meet requirements
7.3.5 Design and Development Verification Verify the design outputs meet input requirements
7.3.6 Design and Development Validation Validate the product is okay for application or use
7.3.7 Control of Design and Development Changes Review, verify, and validate any design changes
7.4 Purchasing
7.4.1 Purchasing Process Evaluate, select, monitor, and control your suppliers
7.4.2 Purchasing Information Create purchase orders describing supplier products
7.4.3 Verification of Purchased Product Check purchases to ensure they meet requirements
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision Plan and control production and service activities
7.5.2 Validation of Production & Service Processes Examine the process if you can’t check the product
7.5.3 Identification and Traceability Identify the product and its inspection and test status
7.5.4 Customer Property Exercise care with any customer property
7.5.5 Preservation of Product Handle, store, package, and protect the product
7.6 Control of Monitoring and Measuring Equipment Calibrate measuring equipment for valid results
8. Measurement, Analysis, and Improvement
8.1 General Plan, measure, analyze, and improve processes
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction Ask customers what they think about your products
8.2.2 Internal Audit Evaluate conformity and effectiveness of system
8.2.3 Monitoring and Measurement of Processes See if processes are achieving planned results
8.2.4 Monitoring and Measurement of Product Verify products meet acceptance criteria
8.3 Control of Nonconforming Product Prevent use or delivery of nonconforming product
8.4 Analysis of Data Analyze effectiveness and identify improvements
8.5 Improvement
8.5.1 Continual Improvement Continually improve effectiveness of quality system
8.5.2 Corrective Action Fix detected problems and prevent recurrence
8.5.3 Preventive Action Avoid potential problems by preventing occurrence
Gap Analysis Report Summary

Result/Observations
Gap Analysis Report Summary
Result/Observations
ISO/TS 16949:2009 Gap Analysis Checklist

ISO 9001:2008
REQUIREMENTS
SECTION

4 QUALITY MANAGEMENT SYSTEM


4.1 General Requirements

This clause asks you to identify how management applies the


process approach to achieve the effective and efficient control of
processes, resulting in performance improvement. Specifically this
4.1 section is looking for an overall process evaluation of all quality
related processes and their interrelationships. Look to see that your
organizational processes are defined and that consideration is given
to the items described below.

Is there a Quality Management System in place that has been


4.1 established and documented to meet the requirements of the
ISO/TS 16949:2009 Technical Specification?

4.1 Look for documentation of the processes included in the QMS

Look for information on the relationship and sequence of the QMS


4.1
processes.

Ask Management if operation and control of processes is effective.


4.1
How do they know if it is effective?

Ask how they are able to know if resources and information needed
4.1
to support processes have been provided.

4.1 Is there any information on the effectiveness of processes?

4.1 How are improvements made to processes?

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Is there implementation of process measure, monitoring and


4.1
analysis?
What processes does your organization outsource?
4.1
How are the process controlled?
4.2 Documentation Requirements

This section addresses how you use documents and records to


support effective and efficient operation of your organization. A
4.2
review of your processes, procedures, work instructions, and
records will determine if the standard requirements are met.

4.2.1 General

Does your quality system documentation include the documentation


4.2.1
required by the technical specification ISO/TS 16949?

Is the documentation sufficient to ensure adequate operation of the


4.2.1
QMS?

Is the documentation sufficient to ensure adequacy for the size and


4.2.1 type or organization, complexity and interaction of processes and
competency of personnel?

Does the quality management system documentation include the


4.2.1
following:

4.2.1 Documented statements of a quality policy and quality objectives?

4.2.1 A quality manual?


Documented procedures required by ISO/TS 16949:2009? (there
4.2.1
are seven)

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Documents needed by the organization to ensure the effective


4.2.1
planning, operation and control of its processes?

4.2.1 Records required by ISO/TS 16949:2009?


Is there a list or other means of identifying other documentation
4.2.1 required by your QMS?
Are the required documents available?

4.2.1 Does the QMS documentation include Quality Records?

4.2.2 Quality Manual

4.2.2 Review the Quality Manual if available:

4.2.2 What is the scope of your QMS?

4.2.2 What processes have been excluded? Is this appropriate?

Is a description or illustration of the interrelation of the processes


4.2.2
included?
4.2.2 Does the Quality Manual include a scope?

4.2.2 Does the Quality Manual adequately describe the QMS?

Does the Quality Manual document or reference the required


4.2.2
documented procedures?
4.2.3 Control of Documents

4.2.3 A documented procedure is required.

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Do you have a formal procedure regarding the control of documents


4.2.3
for your organization?
4.2.3 Are documents approved prior to release?

4.2.3 Are documents updated and re-approved prior to release?

4.2.3 How are changes identified?

Are documents available to those that need to use them?


4.2.3
How is the most current version kept in the correct locations?

Can users easily identify documents? Can users easily read the
4.2.3 documents? Are the documents easy and accessible for the
employees use?

If documents such as reference books, user’s manuals and other


4.2.3
outside documents are used, how are they controlled?

How are old documents handled? Are they removed from use?
Are they labeled?
4.2.3 Is a copy maintained for reference?
Is there any chance that an old document could be used by
accident?

Does the organization adequately document (revision level, date,


4.2.3
etc.) the revision level, date, etc.?
4.2.4 Control of Quality Records

4.2.4 A documented procedure is required by this clause of the standard.

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4.2.4 Is there a documented procedure in place for records control?

Where are records kept?


4.2.4 Is this identified somewhere so users can easily find records?
Can users identify the records? Are the records legible?

How are the retention times, storage requirements, and their


4.2.4
disposition identified?
Are they stored in areas and locations are suitable to prevent loss,
4.2.4
damage or deterioration?
4.2.4 Can they be retrieved?

4.2.4 How long does it take?

4.2.4 Are records disposed of according to the retention times?

If the documents and or records are in the network or Internet, can


4.2.4
they be changed?

Are records available on demand? Is there evidence that records


4.2.4
are easily retrievable for the organization?

5 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment

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This section asks you to identify how your top management


demonstrates its leadership, commitment and involvement. Is
management communicating the importance of meeting customer
requirements? Verify how this is being done, interview personnel to
5.1
see if this is actually being done. Is the quality policy signed off by
top management, do they know it? Review management review
meeting minutes. Ask how resources are determined. Remember
resources are not limited to people.

Have employees heard about the importance of meeting customer


requirements?
5.1
What role did Top Management play in communicating this to
employees?
What role did Top Management play in establishing the Quality
5.1 Policy?
What evidence is there of their role?

How were the Quality Objective established? (Have they been


established?)
5.1 What evidence is there of Top Management involvement?
Is there a strong linkage between the quality objectives and the
quality policy?

Can you see evidence of Top Management involvement in


5.1
Management review?
What process is used for Top Management to identify and provide
5.1
resources necessary for the QMS?

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Is the organization headed in the right direction, do the


management review minutes show positive trends for key
5.1 measurables such as customer satisfaction, customer returns,
delivery, and other key customer expectations identified in 5.2
Customer Focus?

Does management show involvement and take action when things


5.1
are not going in the right direction?

5.2 Customer Focus

This is a requirement that may be defined in a document describing


how your organization addresses this clause. If no document is
5.2
available interview top management for compliance. Top
management and other personnel should be involved in this section.

Is there a process in place to identify your customer requirements?


5.2
How is Top Management involved?

How does Top Management know if customer requirements are


5.2
being met?

Is your organization aimed at achieving customer satisfaction?


5.2
How?

Are all types of customers: consumer, client, end user, retailer, and
5.2
beneficiary identified?

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Does the organization gather the type of information that could be


translated into physical (dimensional), sensory (smell, touch, taste),
5.2 behavioral (courtesy, honesty), temporal (punctuality, reliability),
ergonomic (linguistic, physiological, human safety), and functional
terms?

Do you include the following expectations:


satisfaction/dissatisfaction, customer complaints/rejects, product
5.2
requirements including regulatory and legal and product failure
information?

5.2 How do expectations translate into requirements?


How is the organization distinguishing between product and
5.2
business requirements?
5.2 How are customer requirements prioritized?
Are customer expectations gathered at least once a year with the
5.2
business planning cycle?
Is the information gathered suitable for converting into
5.2 requirements, setting objectives, identifying processes, and for
improvement?
Does the process provide confidence that fulfilling the requirements
5.2
will achieve customer satisfaction?

Is the process conducted from a narrow compliance viewpoint or is


5.2
it conducted with the idea that customer satisfaction is the goal?

5.3 Quality Policy

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Review the quality policy, management, personnel, management


review meeting minutes and other documents that might apply to
5.3
this clause for compliance. Evaluate how the quality policy leads to
improvements.

Is the quality policy appropriate for the organization and aligned with
5.3 customer expectations, business environment, and management
goals?

Does the quality policy include a “commitment to meeting


5.3
requirements and to continual improvement”?

How does the quality policy provide a framework for establishing


5.3
and reviewing quality objectives?
What is the relationship between the quality policy and the
5.3
objectives that are set?

How is it communicated and deployed to be understood at


5.3
“appropriate” levels of the organization?

Is the quality policy reviewed at a minimum once a year and do the


5.3 management reviews evaluate the need for change to the quality
policy reference?

5.3 Does the quality policy inspire and lead organization forward?

5.4 Planning

5.4.1 Quality Objectives

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Review your defined quality objectives. Do your quality objectives


translate your quality policy into measurable goals? Are they
documented so all personnel knows what they are and how the
5.4.1
objectives apply to their processes? Are the quality objectives being
reviewed? Are they measurable? Do the objectives contain
commitment to the continual improvement of the QMS?

5.4.1 Review Quality Objectives:

5.4.1 Where are objectives defined for meeting product requirements?

At what levels have quality objectives been established?


5.4.1
Department? Process?

How are objectives measured?


5.4.1
How do they contribute to meeting the quality policy?
5.4.1 How are the objectives deployed?

Do the quality objectives show continual improvement?


5.4.1
If not, why not?

Do the organization’s objectives target the areas that are important


5.4.1
to the customer (refer to 5.2 Customer Focus)?

5.4.2 Quality Management System Planning

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Review the documents or evidence in the QMS complying with this


clause. Verify planning includes requirements for continual
5.4.2 improvement specified in clause 8.1. Verify quality planning includes
resources and takes into account the needs of your organization as
changes occur.

5.4.2 What quality planning process is in place?


a) How does the planning process address quality objectives for
5.4.2
new processes or products?

b) How are business and external changes evaluated and


5.4.2 approved?
c) Does this take into account how changes will affect the QMS?

Is there evidence of planning for customer-oriented processes and


5.4.2
support processes?
5.4.2 Is there Analysis for each process?
Is there evidence that top management is involved in quality
5.4.2
planning?
Do the QMS planning records show a continual improvement plan
5.4.2
for the objectives and the QMS?
Is the QMS planning driven and linked to the Management Review
5.4.2
process?

5.4.2 Is there a process for controlling changes from QMS planning?

Does the planning include all the appropriate processes? (such as:
5.4.2 Customer Oriented Processes-COPS, Management Oriented
Processes-MOPS, Support Oriented Processes-SOPS)

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Are the improvement targets appropriate to achieve customer


5.4.2
satisfaction?

Will the plan accomplish the task of meeting the customers’ needs
5.4.2
and expectations expressed in 5.2 Customer Focus?

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority


Verify how top management has defined responsibilities and
5.5.1 authorities. This information could be in the form of an
organizational chart.

Review documentation on responsibility and authority.


5.5.1
Is it defined?

Do employees clearly understand their roles and the organizational


5.5.1
lines of authority?
5.5.2 Management Representative

Verify the appointment of the management representative. The


management representative is now responsible for implementing
and establishing the QMS. Verify how customer requirements are
5.5.2
communicated throughout the organization. If more than one
management representative is appointed, how are the
responsibilities and authorities handled?

Is the management representative a direct report to the CEO /


5.5.2
President / General Manager and a part of top management?

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Is the management representative actively involved in the


5.5.2
implementation and maintenance of the QMS?
Does he/she ensure that the processes of the QMS are established
5.5.2
and maintained?

5.5.2 Is the Management Representative knowledgeable of the QMS?

Does he/she report to top management on the performance of the


5.5.2
QMS and the need for improvement?

Does he/she promote awareness of customer requirements


throughout the organization?
5.5.2
Are there meeting minutes, meeting notices, bulletins, and / or
newsletters?

5.5.2 Is he/she promoting the correct/important customer requirements?

5.5.3 Internal Communication

Verify the internal communication processes of your organization. It


could be in the form of internal memos, bulletin boards, or meetings.
Assess the communication for information on the QMS,
5.5.3
effectiveness of the processes, and changes to the system. Verify
this information is communicated to all levels within the
organization.

5.5.3 Has the organization established communication processes?

5.5.3 Do the communications include the effectiveness of the QMS?

5.5.3 What tools does the organization use for internal communication?

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Does the communication communicate both process information


5.5.3
and its effectiveness?
5.5.3 What processes are they communicating?
How are they communicating effectiveness of processes? Is it
5.5.3
appropriate?

Do employees understand the status and effectiveness of the QMS,


5.5.3
where the organization is headed, and their role and contribution?

5.6 Management Review

5.6.1 General

Review your management review records for conformance. The


requirements for management review input could be presented in
an agenda or written in a document. Verify the input requirements
are discussed and recorded in your management review record.
Review the management review record for compliance to the
5.6.1
requirements. If there is a document defining the management
review process then this will need to be assessed for conformance.
Also management is required to identify customer needs. If new
customer needs are identified does management review identify the
improvements made to meet these new customer needs?

5.6.1 Is there a schedule for management review?


Does the review frequency ensure the QMS’s suitability, adequacy,
5.6.1
and effectiveness?

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5.6.1 Are there records or management reviews?

Do the organization’s management reviews include assessing


opportunities for improvement and the need for changes to the
5.6.1
quality management system, including the quality policy and quality
objectives?
Are the organization’s records from management reviews
5.6.1
maintained?
5.6.2 Review Input
Does the Management Review Process address all the required
5.6.2
Inputs?
5.6.2 a) Results of audits

5.6.2 b) Customer feedback

5.6.2 c) Process performance and product conformity

5.6.2 d) Status of preventative and corrective actions

5.6.2 e) Follow-up actions from previous management reviews

5.6.2 f) Changes that could affect the quality management system

5.6.2 g) Recommendations for improvements

5.6.3 Review Output


Does the output of management review include actions related to
5.6.3
improvement of the QMS?

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Does the output of management review include processes,


5.6.3 improvement of product related to customer requirements, and
resource needs?
Is there evidence that resources are allocated to meet customer
5.6.3
satisfaction and QMS objectives?
5.6.3 How are resources allocated?

Are management review inputs presented in such a fashion that


5.6.3 management can easily identify the current performance and
improvement opportunities of each of the items presented?

If the current performance is inadequate, are actions identified in the


5.6.3
output to address improvements needed?

6 RESOURCE MANAGEMENT
6.1 Provision of Resources

Verify that resources are available for the QMS. Assess resources
for addressing customer satisfaction, implementing and improving
6.1 the QMS processes. Are resources available in a timely manner?
Resources can be people, information, supplies, equipment, facility,
work environment, or financial resources.

Is there evidence to show that resources are being provided as


6.1
needed to develop, maintain and improve the QMS?

6.1 Are resources sufficient to meet customer requirements?

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Does the resource allocation process provide resources in a timely


6.1 manner to implement and improve the processes and to address
customer satisfaction?

Has management provided adequate resources to meet the


6.1
continual improvements targeted?
6.2 Human Resources

6.2.1 General
Verify the training records of personnel, especially as related to
sections 4.0, 5.0, 6.0, 7.0, & 8.0 of the standard. If you have a
6.2.1
training document, assess the document for compliance to the
standard.

6.2.1 Evaluate the competence of personnel:


Do the records indicate that the employees are competent to
6.2.1 perform the job based upon education, training, skills and
experience?

6.2.2 Competence, Training and Awareness

If there is a training document, verify conformance to the


requirements below. If there is no document, determine how
personnel know their activities. The standard places great emphasis
6.2.2
on competency. Assess how your organization evaluates the
effectiveness of training and how personnel know the importance of
their activities. This clause applies to all personnel at all levels.

How is the necessary competence of personnel determined and


6.2.2
defined?

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6.2.2 Has the determined training been provided?

Is there on-going continual education training?


6.2.2
And is this training documented in the employees’ training records?

Is the effectiveness of the training evaluated?


6.2.2 How?
Is there sufficient evidence?
Are personnel aware of the relevance and importance of their
6.2.2 activities and how they contribute to the achievement of the quality
objectives?

Are appropriate records maintained describing employees’


6.2.2
education, training, skills and experience?

Are there competency requirements defined for all types of jobs?


6.2.2
Make sure all types of employees are sampled

Have the competency needs of employees affecting quality been


6.2.2
identified?
Is there a training plan to satisfy these needs?
6.2.2
Is it followed?
6.2.2 Is there new employee orientation and training?

Does it cover relevance and importance of employee activities, and


6.2.2
how they relate to the quality objectives?

Are there records for all employees indicating their training, skills
6.2.2
education and experience?

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Are competent personnel “effectively” carrying out activities and


6.2.2 providing results for the organization through improvement? Are
there weaknesses?

6.3 Infrastructure

This clause addresses how your organization ensures that the


infrastructure is appropriate for the achievement of your objectives.
Verify the facilities are maintained to achieve the conformity of the
6.3
product. Safety, maintenance, management review, and meeting
minutes are some of the records to review. Different processes
within the organization may have different requirements.

6.3 What is your infrastructure?


Does product or service meet requirements when produced or
6.3
delivered using this infrastructure?
Is there adequate space for non- conforming materials or returned
6.3
product from customer?

6.3 Are there adequate facilities (lab) for returned product analysis?

Review the maintenance and prevention maintenance process that


6.3
is used to maintain the facilities. Is it adequate?

6.4 Work Environment

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Examples to look at for compliance would be work methods, safety,


ergonomics, and temperature and humidity controls. Elements that
6.4
may also be included in work environment are information, suppliers
and partnerships, natural and financial resources.

What work environment is needed to meet product or service


6.4
requirements?
6.4 Has this work environment been provided?

Has the organization identified the human and physical factors of


their work environment?
6.4
Physical factors include heat, noise, light, hygiene, humidity,
cleanliness, vibration, pollution, and airflow.
Has the organization identified work rules for people involvement,
6.4
safety rules, and ergonomics?
What process do they use to manage the human and physical
6.4
factors?
Do records show work environment as a root cause for non-
6.4
conformances?

While walking through the facility, monitor the level of housekeeping.


6.4
Is there oil on the floor, chips & dirt, cigarette butts, etc?

What is the general work environment as it relates to noise, air


6.4
quality, etc?

7 PRODUCT REALIZATION
7.1 Planning or Product Realization

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This section may be addressed in a documented procedure or in the


quality manual. Does your organization understand the processes
7.1 needed to meet product requirements? The planning activity for the
processes related to product realization must address the
requirements in section 4.1.

For each product/project or contract sampled study the planning of


7.1
the realization process:
7.1 Is there a quality plan for the process?

7.1 Does the plan include appropriate quality objectives?


Do the objectives relate to customer requirements and the business
7.1
goals established in 5.4 Planning?

Was the need to establish new processes and/or change existing


7.1 product realization process, documentation, resources, and facilities
for product identified?

Does the plan specify verification and validation and criteria of


7.1
acceptability of the product as it goes through each process?

Does the plan identify the records necessary for process and
7.1
product conformance?
7.1 Is the plan output appropriate to the operation?

7.2 Customer-Related Processes

7.2.1 Determination of Requirements Related to the Product

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If customer requirements are not understood there is the possibility


of not meeting the customer needs. A review of customer
complaints, surveys, and reports will denote any problems. Also
look at any contract, logs, or orders to see if any amendments have
7.2.1
been made. If so, is the reason for the amendment documented?
This requirement also includes recycling, environmental impact and
characteristics identified as a result of the organization’s knowledge
of the product and manufacturing processes.

7.2.1 How are customer requirements determined?

Are product requirements (physical, functional, ergonomic, etc.)


7.2.1 identified from the customer including delivery and post- delivery
activities determined?

Does the organization add requirements that they identified that


were not specified by the customer, but necessary for intended or
7.2.1
specified use?
Is there a process for this to happen?
Are obligations related to the product, including regulatory and legal,
7.2.1
identified?

7.2.1 Are additional requirements determined by the organization?

7.2.1 Are these requirements input into 5.2 Customer Focus?

7.2.1 Are product requirements gathered only during contract stages?

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Does the organization try to analyze / summarize product


7.2.1 requirements gathered between customers, by product family, etc…
as to input the planning process?

7.2.2 Review of Requirements Related to the Product

When looking at the documents (records, procedure, and work


instructions) consider required delivery dates, applicable standards,
7.2.2
and any organizational requirements. Is the same process being
followed for verbal orders?

7.2.2 How does your organization review customer requirements?

7.2.2 What information is reviewed?

7.2.2 What records are maintained?

7.2.2 How are customer requirements confirmed on a verbal order?

7.2.2 How is your ability to meet order requirements confirmed?

7.2.2 How are changes to orders handled?


Does the organization review product requirements for the products
7.2.2
sampled from 7.2.1?
Are the product requirements from 7.2.1 reviewed before the
7.2.2
commitment to produce is made?
7.2.2 Are differing requirements resolved?

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Does the review make sure that they have the ability to meet all
7.2.2
requirements before commitment to supply?

7.2.2 Is the review and subsequent actions documented?

When customer requirements or product requirements are changed,


7.2.2
are relevant personnel made aware of the change?

Is each order reviewed, documented and approved prior to


7.2.2
commitment to the customer?
When the customer provides little to no documented requirements,
7.2.2 does the organization review the requirements from 7.2.1 with the
customer?

7.2.3 Customer Communication

If there is no document available regarding customer


communication then the questions below should be asked to
determine compliance to this clause. Customer requirements are
7.2.3
important and usually involve different levels in the organization. Ask
different levels to see if the answers are consistent and do they
agree with the organizations policy and objectives.

7.2.3 How do you communicate product information to customers?

What process is used for customer enquiries, contracts or order


7.2.3
handling, including amendments?
What mechanism is in place to collect customer feedback, including
7.2.3
complaints?

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Is the language specified by the customer used for


7.2.3
communications?
7.3 Design and Development
Does product and manufacturing process design focus on error
7.3
prevention rather than detection?

If your organization does not have a PRODUCT DESIGN and


DEVELOPMENT function, the elements associated with
7.3 PRODUCT DESIGN will not be applicable and exclusion should
be noted. However, all MANUFACTURING PROCESS DESIGN
cannot be excluded.

7.3.1 Design and Development Planning

This section for planning is done to the level necessary to achieve


the design/development objectives. Planning could be in the form
of a flow chart (GANTT chart, PERT chart) to give the information. A
7.3.1 review of projects and records will determine how this is being done
and if consistent with the clause. Advanced Product Quality
Planning (APQP) is one acceptable method to develop products
and/or manufacturing processes.

How does your organization plan and control the design and
7.3.1
development of product?
Sample various products.
7.3.1 For each product that was designed or developed check the
following:

7.3.1 Was there a plan for the design and development of the product?

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7.3.1 Were the stages of design and or development determined?

Were reviews, verification, and validation activities conducted for


7.3.1
each stage?
Were the responsibilities and authorities for these activities
7.3.1
identified?

How was the interface between the different groups managed for
7.3.1
effective communication and clarity of responsibilities?

Was the output of the plan updated as the design or development


7.3.1
progresses?
7.3.2 Design and Development Inputs

Although the standard does not specifically require it, consider


preparing a document to address the input requirements in order to
7.3.2
avoid any misunderstandings. Review any document or paperwork
that addresses this clause.

Continue the same product samples from


7.3.2
7.3.1 Design and/or Development Planning:
Were inputs relating to product requirements defined and
7.3.2
documented?

7.3.2 Did they include functional and performance requirements?

7.3.2 Did they include applicable regulatory and legal requirements?

Did they include applicable information derived from previous similar


7.3.2
designs?
Did they include other requirements essential for design and /or
7.3.2
development?

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7.3.2 Is there evidence that the inputs were reviewed for adequacy?

Is there evidence that incomplete, ambiguous, or conflicting


7.3.2
requirements were resolved?
7.3.3 Design and Development Outputs

Verify the outputs of the design/development satisfy the


design/development inputs. Assess the documents that apply to
7.3.3 this clause for compliance. This clause does not require a quality
record, but to demonstrate compliance some form of quality records
should exist.

Continue the same samples from 7.3.1 Design and/or Development


7.3.3
Planning:
Were the design outputs documented in a manner that enables
7.3.3
verification against the inputs?
7.3.3 Was the output reviewed prior to release?

7.3.3 Did the outputs meet the input requirements?

Did the output provide appropriate information for production and


7.3.3 service operations (read as process control, i.e. ongoing functional
testing, product characteristics etc.)?

7.3.3 Did it contain or reference product acceptance criteria?

Did it define characteristics of the product essential for safe and


7.3.3
proper use?
7.3.4 Design and Development Review

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Verify the design review record to confirm compliance. Confirm the


reviews are taking place, done according to the plan, appropriate
attendance at the reviews, and follow up action has taken place.
7.3.4
The standard does not require the number of design reviews that
should be conducted. The review is intended to confirm internal and
external needs have been taken into consideration or addressed.

How do project managers identify the stages of design where


7.3.4
design review is required?
7.3.4 What is covered in design review?
Continue to follow the same product samples from 7.3.1 Design
7.3.4
and/or Development Planning:
7.3.4 Were design reviews conducted at suitable frequencies?

7.3.4 Were they conducted as per the “planned” schedule?

Did the review evaluate the ability to meet the requirements needed
7.3.4
at the stage, and identify problems and proposed follow up actions?

7.3.4 Are they accomplishing what is required at the stage?

7.3.4 Did they identify problems and propose action?


Did the review include representatives of the functions involved in
7.3.4
that stage of the design?
7.3.4 Was the review well documented including follow-up actions?

7.3.5 Design and Development Verification

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Verification considers the product after it is finished. Verification


makes the determination that the product meets the stated
requirements. This can be done by review of test data, calculations,
7.3.5 or additional testing. For verification the capability of the product
must meet the specified requirements and there must be objective
evidence available to demonstrate it. Assess the records for
compliance.

7.3.5 How is verification planned?

7.3.5 What does verification include?


Continue the same product samples from
7.3.5
7.3.1 Design and/or Development Planning:
Was the output of the design or development verified to ensure that
7.3.5
it met the inputs?
Did it “ensure” that the output meets the input without any
7.3.5
ambiguity?
Were results of the validation and any subsequent follow-up actions
7.3.5
recorded?
7.3.6 Design and Development Validation

Validation assures that the design/development output conforms to


defined user needs and is capable of meeting the requirements for
7.3.6 the intended use. Validation is usually performed after verification.
Verify that the requirements of this clause are met by reviewing the
validation records.

Continue the same product samples from


7.3.6
7.3.1 Design and/or Development Planning:

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How is validation planned?


7.3.6
What is included in validation?

Was the output of design or development validated to test whether


7.3.6 the product is “capable of meeting the requirements for the specified
or intended use or application”?

Note: the validation should be testing the product as close to real


use as possible. It should be testing the product under the various
7.3.6
conditions or worst conditions that it will be put to use by the
customer.

Was the validation completed before delivery or implementation of


7.3.6
the product whenever “practicable”?

If full validation was impractical prior to delivery or implementation,


7.3.6
was partial validation performed to the extent applicable?

Were the results of the validation and any subsequent follow-up


7.3.6
actions recorded?
Does the validation process include an analysis of field reports for
7.3.6
similar products?
Does verification and validation evident for both product and
7.3.6
manufacturing processes?

7.3.7 Control of Design and Development Changes

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Some of changes that may take place are omissions, errors or


inconsistencies in the design or requirements, changes in statutory
or regulatory requirements, or issues raised during reviews. It is
7.3.7 important that changes be documented and actions taken to prevent
any possible effect on the product. Assess the design/development
records for compliance and verify that changes have been
communicated to all parties.

7.3.7 How are changes to the design recorded and implemented?

Are the changes verified, validated and approved prior to


7.3.7
implementation?
Are the changes evaluated for the effect on constituent parts and
7.3.7
delivered products?
Are the results of the review of changes and any necessary actions
7.3.7
recorded?
Do design and development changes include all changes during the
7.3.7
product program life?
7.4 Purchasing

7.4.1 Purchasing process

This clause asks your organization to base the type and extent of
control of suppliers on the effect of the purchased material on both
7.4.1
the product realization processes and products produced. Assess
the records of supplier evaluations and follow up actions.

Is there a process in place to ensure that purchased product


7.4.1
conforms to requirements?

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Is the control appropriate to effect the purchased product has on the


7.4.1
subsequent or final product?
7.4.1 Is there a method of controlling the suppliers?

7.4.1 How are suppliers selected?

7.4.1 What criteria are there for evaluating suppliers?

7.4.1 Are evaluation and any necessary actions being recorded?

7.4.1 Is there a list of approved suppliers?

7.4.1 Does the list include all the appropriate types of suppliers?

Were the suppliers evaluated and selected based upon their ability
7.4.1
to supply product in accordance with requirements?

7.4.1 Was there a criteria for their selection?

7.4.1 Were the suppliers periodically evaluated?

7.4.1 Were their criteria for their periodic evaluation?


Did they base their purchasing commitments on supplier
7.4.1
evaluation?

7.4.1 Are there records of supplier selection and evaluation?

Does the organization’s purchasing process include all products and


7.4.1 services that affect customer requirements such as sub-assembly,
sequencing, sorting, rework and calibration services?

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When there are mergers, acquisitions or affiliations associated with


7.4.1 suppliers, the organization should verify the continuity of the
supplier’s quality management system and its effectiveness.

7.4.2 Purchasing Information


Assess how the organization describes the products, materials or
7.4.2
services that are purchased.
7.4.2 What does purchasing information include?

How do your purchasing personnel confirm that the purchase


7.4.2
requirements are complete and correct before the order is placed?

Does the organization use purchase orders?


7.4.2
Do the purchase orders include information describing the product?

Do the P.O.’s include requirements for approval or qualifications (as


7.4.2 appropriate) for approval of products, procedures, equipment and
personnel?

7.4.2 Do the P.O.’s include quality management system requirements?

Does the purchasing process include an evaluation to ensure the


7.4.2
adequacy of specified requirements prior to release?

7.4.3 Verification of Purchased Product

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Assess how the organization has defined the inspection process for
compliance and verify evidence of product acceptance. Verification
7.4.3
of purchased product performed at the supplier’s premises is
seldom used. If being done assess the process for compliance.

Is inspection used to verify that purchased product meets


7.4.3 requirements?
What other methods are used in addition to inspection?

Are the activities for verification of purchased product identified and


7.4.3
implemented?

If the customer performs verification activities on the supplier’s


7.4.3
premises, are the methods of verification and release specified?

Is there evidence that purchased product quality, delivery, or cost is


7.4.3 affecting in- process, delivered product, and /or customer
satisfaction/customer dissatisfaction?

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision


The requirements noted below cover process control, inspection
and testing, inspection and test status, and servicing and
7.5.1
requirements for the release, delivery, and post-delivery of the
product.

7.5.1 How are production and service provision controlled?

7.5.1 Where are the product characteristics documented?

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7.5.1 How do personnel know what equipment to use for a process?

Does documentation identify what monitoring and measuring


7.5.1
equipment should be used, and when?

Select a representative sample of the processes of the organization.


7.5.1 Is there a quality plan or other document that identifies the
characteristics controlled in each step of the process?

Is enough information available to specify the characteristics of the


7.5.1
product?

Are work instructions available for each process step or are


7.5.1
operators able to explain how to perform that step of the process?

7.5.1 Is the equipment suitable for the work


performed and do records show that maintenance is planned and
7.5.1
being carried out?
Do they have the necessary gauge and/or monitoring equipment for
7.5.1
process and product monitoring?
Do records indicate that the monitoring activities are properly
7.5.1 implemented and that all persons operating the process are
following it?
Do they have defined processes for release, delivery and post-
7.5.1
delivery activities?

Does the organization control the provision of product and service


7.5.1
so that it is meeting or exceeding customer expectations?

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Does monitoring and measurement data show that the organization


7.5.1
is meeting objectives set for the product?

Validation of Processes for Production and Service


7.5.2
Provision

If special processes are part of your organization’s scope the above


requirements will be assessed for compliance. Define conditions
7.5.2
and the criteria for revalidation. If you have no special processes,
identify that in the quality manual.

Does your organization have any processes for production and


service where the output cannot be verified by monitoring or
7.5.2
measurement?
Do you validate these processes?

7.5.2 How is validation performed?


If the process being audited is a special process, how is validation
7.5.2
performed?

7.5.2 Does validation demonstrate the ability to achieve planned results?

Does the validation process include defined criteria for review and
7.5.2
approval of the process?

7.5.2 Does the validation process include validation of processes?

Does the validation process include validation of equipment and


7.5.2
personnel?
Does the validation process include use of defined methodologies
7.5.2
and procedures?

7.5.2 Does the validation process include requirements for records?

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7.5.2 Does the validation process include Re-validation?

Does the organization validate all of its processes for all its
7.5.2 production and service provision where the resulting output cannot
be verified by subsequent monitoring or measurement?

7.5.3 Identification and Traceability


Product need to be identified in such a way as to know its status,
7.5.3
that is, is good, bad, or don’t know?
7.5.3 How is product identified?

7.5.3 How is measuring and monitoring status identified?

Does your organization control and record the unique identification


7.5.3
of the product, where traceability is required?

7.5.3 Is the product identified throughout the process until it is shipped?

Is the identification clear and legible? Is each form or tag to be filled


7.5.3
out completely?
Is the status of the product in relationship to measurement and
7.5.3
monitoring clearly discernible?

7.5.3 How does the operator know what has and has not been checked?

7.5.3 To what level is traceability required?

7.5.3 How do they track the product to the traceability level required?

7.5.4 Customer Property

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Property provided by the customer can include intellectual property,


as well as tooling, information, software, containers, or materials.
7.5.4
Remember to include all these items in the review of customer
property.

7.5.4 Is there any customer property used in the process?


How is the customer property identified, verified, protected and
7.5.4
maintained?

Do they have a process of recording and reporting to the customer


7.5.4
any lost, damaged, or otherwise unsuitable product?

7.5.4 Is there evidence that this is happening?

7.5.5 Preservation of Product


Products need to be protected in order to preserve conformity to
7.5.5
requirements
How do you make sure that product quality is maintained during
7.5.5
processing and delivery?
7.5.5 Is any product on the floor, misplaced, mishandled?
Are packaging specs defined and understood?
7.5.5
Are they being followed?

7.5.5 Are there customer complaints related to improper packaging?

Are there customer complaints for damage products during


7.5.5
transport?

7.5.5 Are there opportunities where something may go wrong?

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7.6 Control of Monitoring and Measuring Equipment

7.6 . Review procedures, work instructions and records for compliance.

Has your organization established a mechanism to ensure


7.6 monitoring and measuring is performed consistent with
requirements?

7.6 What action is taken if equipment is found to be out of calibration?

Does your organization take appropriate action on the equipment


7.6
and any product affected above?
7.6 What records are maintained?
How is software used for measuring and monitoring verified prior to
7.6
use and reconfirmed as necessary?
Has the organization identified measurements to be made and the
measurement and monitoring equipment required for conformity of
product?
7.6 Audit the gages: (check quality, manufacturing prototype lab and
maintenance department gages)
Accuracy, precision? How chosen?
Identification?

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Acceptance criteria?
Handling, storage and preservation of inspection, measuring and
test equipment?
Environmental conditions? Location?
7.6
Corrective actions? Frequency of checks?
Audit the calibration program.
NOTE: Monitoring and measuring equipment should be trailed from
processes audited in Production and Service Provision (7.5)

Sample several pieces of equipment used in the organization for the


7.6
following:

7.6 Are they calibrated to International or National Standards?

7.6 Are results recorded?


Daily/weekly mastering of gages before use (usually during plant
7.6
audit)?
Where no International Standard exists, is the basis of the
7.6
calibration recorded?
7.6 Are they adjusted periodically or before use?

7.6 Is calibration status identified?


Are they safeguarded from adjustment that would invalidate the
7.6
calibration?
Are they protected from damage and deterioration during handling,
7.6
maintenance, and storage?
Does the organization have a process to re-assess previous results
7.6 if equipment is found to be out of calibration and have corrective
action taken?

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What action is taken when equipment is found to be out of


7.6
calibration?

7.6 Audit backtracking of product when gage is found to be bad?

7.6 Have they recorded the results of calibration?

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT


8.1 General

Verify that your organization is monitoring, measuring, and


improving the processes. How this is being done is defined by your
8.1 organization. This may be written in procedures, although there is
no requirement for this clause to have a procedure. Assess if your
organization has determined the need for, and use of statistics.

How is product conformance demonstrated?


8.1
Is there a measuring and monitoring process in place?

How is the conformity of the QMS ensured?


8.1
Is there a measuring and monitoring process in place?

Does measuring and monitoring allow continual improvement of the


8.1
effectiveness of the QMS?

Does the process include identification of methods, including


8.1
statistical techniques for the measuring and monitoring?

Have measurement and monitoring activities been defined? What


8.1
do they involve?

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Have measurement and monitoring activities been planned?


8.1
How?

8.1 Have measurement activities been implemented?

8.1 Do they employ applicable methodologies?

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

This clause does not define how your organization is to monitor


information on customer perceptions. For compliance to this clause,
8.2.1 verify how your organization monitors the customer information,
follow through on the methods being used. Are the methods being
used consistent with the quality policy and quality objectives?

What methods does your organization use to monitor information on


8.2.1
customer perception regarding fulfilling customer requirements?

Is there a defined process with documented methodologies for


8.2.1
obtaining customer satisfaction and dissatisfaction?

8.2.1 Are all the types of customers surveyed / interviewed?

Is the number of customers surveyed/interviewed enough to provide


8.2.1
good information, i.e. statistically valid?

Are they surveying/interviewing different departments within the


8.2.1
customer who affect the buying decision?

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How is this information used when determining customer


8.2.1
expectations?

What is the quality of the information gathered? Is the information


8.2.1
gathered useful in improving the organization?

Can they provide evidence of using this information for continual


8.2.1
improvement?

Does the customer satisfaction process provide a true picture of the


8.2.1 perception (opinion) of the organization’s customers? Is the
information gathered useful in improving the organization?

Are the performance indicators headed in the right direction?


8.2.1
Does it show correlation to customer satisfaction?

Is the information gathered being used to improve customer


8.2.1
satisfaction?

Is there an evaluation of the realization process indicators, in order


8.2.1 to better understand the correlation between customer satisfaction
and the product realization performance indicators?

Is the manufacturing process performance monitored?


8.2.1
Do trends show conformity with customer requirements?

8.2.2 Internal Audit

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A documented procedure is required for this clause. Assess the


internal audit procedure for conformance to the requirements below.
8.2.2 Verify the auditors have determined the QMS has been effectively
implemented. It is management’s responsibility to make sure
actions are taken in a timely manner.

8.2.2 Is an internal audit system in place?

8.2.2 Are they being performed on time?


Are they effective?
8.2.2 Do they identify good improvements and eliminate non-
conformances?
8.2.2 How is the audit schedule prepared?

What measures are in place to ensure the audits and auditors are
8.2.2
objective and impartial in the audit process?

Is there a documented procedure and does the procedure define


8.2.2 the responsibilities and requirements for planning and conducting
audits, including audit reports and maintaining records?

How does the management responsible for the area audited take
8.2.2
timely action to eliminate nonconformities and their causes?

Do follow up activities include verification of the corrective action


8.2.2
and the reporting of those results?
Is there an audit schedule that takes into account the status,
importance of areas and activities, and the results of the previous
8.2.2
audit?
Does the audit frequency change?

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8.2.2 Do the records show that the schedule is being followed?

Does the internal audit cover the full scope of the standard as well
8.2.2
as any customer specific requirements?

Do the audit schedule and the audit process indicate that the
8.2.2 current auditing process audits effective implementation and
maintenance of the system?
Have audits, scope and frequency, and methodologies been
8.2.2
defined?
8.2.2 Are the auditors independent of the area audited?
Are audit questions comprehensive?
8.2.2 Are they focused on the performance of the process meeting
planned objectives?
Is the objective evidence recorded for each question?
8.2.2 There should be objective evidence for both conformance and non-
conformances.
Do the questions and the evidence indicate that the audit is
8.2.2 checking whether the QMS is effectively implemented and
maintained?

8.2.2 Are there non-conformances identified in the audit reports?

Are the non-conformances well written, that is, are requirement


8.2.2 cited (is it correct); is there objective evidence, and the nature of the
non-conformance?
Are all the elements audited?
8.2.2 If not, check to see that all the elements are audited by a
combination of the entire year’s audits?

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8.2.2 Are the nonconformities closed out in a timely manner?

8.2.2 Does the organization go back and audit the problem?

8.2.2 Is there objective evidence of verification results?


Is the internal audit generally finding the same type of problems as
8.2.2
the current audit?
8.2.2 Are the problems well documented?
Is there objective evidence for areas of conformance and
8.2.2
nonconformity?
Are the non-conformances closed out on a timely basis (three-
8.2.2
month window at the most)?
8.2.2 Are the problems repeating?

8.2.2 Are the number and type of problems going down?

Are the summary results of the audits communicated to their


8.2.2
respective process owners and Management?

8.2.3 Monitoring and Measurement of Processes

Verify that your organization has defined and is performing the


measuring and monitoring activities needed to confirm product
conformity. Looking at the process data will provide evidence if
8.2.3 process parameters or specifications have been identified. If not,
was corrective action taken?
Compliance would also include observing the measurement and
monitoring processes.

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How are QMS processes monitored? Where are appropriate


8.2.3
measurements identified?
Are results evaluated to determine if the QMS processes are
8.2.3
achieving the planned results?
When the results are not achieved, are corrective actions taken to
8.2.3
confirm conformity of the product?
Are the policies, procedures or requirements (i.e. process
8.2.3
characteristics) clearly identified?
Are the characteristics related to customer or product requirements
8.2.3
for the processes identified?
8.2.3 What are the criteria and methods used to control the processes?

8.2.3 Are the methods suitable?

How do they ensure that the process is operating effectively and


8.2.3 that the necessary resources and information are available to
support operation and measurement of processes?

8.2.3 How are the processes measured, monitored and analyzed?

Is there evidence to show that the measurement and monitoring of


8.2.3
the process is satisfactory in meeting customer requirements?

Are actions taken to achieve process goals and for continual


8.2.3
improvement?

8.2.3 Do the criteria and methods used effectively control the process?

Are the process metrics related to customer requirements and


8.2.3
organizational objectives?

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8.2.3 Is the process improving and is it benefiting the customer?

8.2.4 Monitoring and Measurement of Product

This section includes all measurement activities from receiving


inspection to product delivery. Assess work instructions,
8.2.4 procedures, and records to verify compliance. Verify that the
records provide evidence that product criteria are met. Do the
records also identify the person responsible for release?

Are the policies, procedures or requirements (i.e. process


8.2.4
characteristics) clearly identified?

Are the characteristics related to customer or product requirements


8.2.4 for the processes identified in General Requirements (4.1) and
Planning of Product Realization (7.1)?

Is product measured and monitored to verify that product


8.2.4
requirements are met?
8.2.4 Where are planned measurements identified?
What records are maintained?
8.2.4
Do they show conformance with acceptance criteria?
Who is authorized to release product? Is the appropriate person
8.2.4
releasing product?

Is there evidence that product release and service delivery does not
8.2.4 proceed until all activities have been completed (unless otherwise
approved by a relevant authority or customer)?

8.2.4 What are the criteria and methods used to control the process?

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8.2.4 Are the methods suitable?

How do they ensure that the process is operating effectively and


8.2.4 that the necessary resources and information are available to
support operation and measurement of processes?

8.2.4 How is the process measured, monitored and analyzed?

Is there evidence to show that the measurement and monitoring of


8.2.4
the process is satisfactory in meeting customer requirements?

Are actions taken to achieve process goals and for continual


8.2.4
improvement?

8.2.4 Do the criteria and methods used effectively control the process?

Are the process metrics related to customer requirements and


8.2.4
organizational objectives?

8.2.4 Is the process improving and is it benefiting the customer?

8.3 Control of Nonconforming Product


A documented procedure is required for this clause. Verify the
8.3 correction of nonconforming product and the re-verification by
review of the records.
How has your organization ensured that product which does not
8.3 conform to requirements is identified and controlled to prevent
unintended use?

8.3 Is there a procedure that identifies responsibilities for taking action?

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Does the procedure identify the ways that nonconforming product


8.3
can be handled?
8.3 What records are maintained?
Is nonconforming product re-verified after correction to demonstrate
8.3
conformity to requirements?

What action does your organization take when a nonconformity is


8.3
detected after delivery or use has started?

Is there a documented procedure for dealing with nonconforming


8.3
product?
8.3 Is the organization following the procedure?
Is non-conforming product (including product thought to be non-
8.3 conforming) stored separately so that it does not get mixed with
conforming product?
Does the organization promptly dispose of product that prevents a
8.3 large accumulation of non-conforming product? Is there evidence of
this?

How does the organization deal with non- conforming product?


8.3
Check log or file for deviation or concession records

Are records maintained of the nature of nonconformities and


8.3
subsequent action?
What actions are taken if product non-conformance is discovered
8.3
after shipping?
Are there customer complaints or rejects due to non-conforming
8.3
product being shipped to customers?

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Based on internal and external reject and rework data, are there
8.3 problems indicated related to handling, packaging, storage and
delivery?

8.4 Analysis of Data

Assess the methods used to collect and analyze the data required
below. Confirm the analysis of the data is used to demonstrate the
8.4
suitability and effectiveness of the QMS and the system continues
to improve.

How is data from measuring and monitoring activities used to


8.4 demonstrate suitability and effectiveness of the QMS?
How is it used to continually improve the QMS?

Does the organization analyze data for improvement?


8.4
How often?
Does the data provide information on customer satisfaction and/or
8.4
dissatisfaction?
Does the data presented clearly indicate the trend in customer
8.4
satisfaction?
Is the data analyzed to understand things gone right or things gone
8.4
wrong?
Does the organization trace success or failure to projects
8.4
performing well or poorly?

Does the organization study opportunities for improvement and use


8.4 techniques such as Pareto analysis or critical requests from
customers to decide on new opportunities?

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Does the organization analyze non- conformance data, customer


complaints and customer returns?
8.4
Data analyzed should be collected to allow analysis of all customer
requirements.
Is the data available in a form to allow analysis and identification of
8.4
projects?
Is information on characteristics of processes, product and their
8.4
trends analyzed?
8.4 Is process and product data tracked and trended?
What is the process when a process or product is found not meeting
8.4
customer requirements?
Does the organization identify improvement opportunities for the
8.4
characteristics?
Does the organization gather and analyzing information on
8.4
suppliers?
Does the organization track supplier data as it relates to deliveries
8.4
and receiving inspection?

8.4 Is this data used for selecting and evaluating suppliers?

8.4 How is the information used to identify improvement?

Does the data analysis clearly show what is happening to customer


8.4 satisfaction, conformance to customer requirements, characteristics
of processes, product and their trends, and suppliers?

8.4 Does the data point to improvement opportunities?

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Does the organization determine, collect and analyze appropriate


data to demonstrate the suitability and effectiveness of the quality
8.4 management system and to evaluate where continual improvement
of the effectiveness of the quality management system can be
made?

Does the organization’s data analysis include data generated as a


8.4 result of monitoring and measurement and from other relevant
sources?
8.4 Is data compared to competitors or benchmarks?

8.5 Improvement

8.5.1 Continual Improvement

This clause contains many of the requirements already specified in


8.5.1 previous clauses. Verify that the requirements are being used to
plan for continual improvement.

How does your organization, continually improve the effectiveness


8.5.1
of the QMS?

Does the organization continually improve the effectiveness of the


quality management system through the use of the quality policy,
8.5.1
quality objectives, audit results, analysis of data, corrective and
preventive actions and management review?

8.5.2 Corrective Action


A documented procedure is required for this clause. Review your
8.5.2
records to confirm conformance.

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8.5.2 What is identified as corrective action?


Are the actions taken appropriate to the impact of the problems
8.5.2
encountered?

Is there a documented procedure for corrective action, and is there


8.5.2
objective evidence that they follow it?

8.5.2 Sample several corrective actions:

8.5.2 Was the non-conformity (i.e. problem) identified?

8.5.2 Was the cause of non-conformity determined?


Was the need for actions to ensure problem do not repeat
8.5.2
evaluated?
8.5.2 Was corrective action implemented?

8.5.2 Were results of the corrective action recorded?

8.5.2 Was the corrective action taken?

8.5.2 Does the data show that the corrective action is effective?

8.5.2 Do problems repeat?


Are corrective action performance trends monitored, analyzed and
8.5.2
improved?
8.5.3 Preventive Action
A documented procedure is required by this clause. Review records
8.5.3
to confirm conformance.

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Has your organization established a procedure to eliminate the


8.5.3 cause of potential nonconformities to prevent their occurrence?
Is there objective evidence it is followed?

8.5.3 What does the organization identify as preventive action?

Are the actions taken appropriate to the impact of the problems


8.5.3
encountered?
8.5.3 Sample preventive actions:

8.5.3 Was a potential non-conformity (i.e. problem) identified?

8.5.3 Was it determined that preventive action was needed?

8.5.3 Were the results of action taken recorded?

8.5.3 Was preventive action taken reviewed?

8.5.3 Does the data show that the preventative action is effective?

8.5.3 Are problems eliminated before they occur?

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Gap Analysis Schedule
Section Description Process Owner Scheduled Audit Date
4 Quality Management System
4.1 General Requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Records
4.2.4.1 Records Retention
5 Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority, and Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6 Resource Management
6.1 Provision of Resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, Awareness, and Training
6.3 Infrastructure
6.4 Work Environment
7 Product Realization
7.1 Planning of Product Realization
7.2 Customer related processes
7.2.1 Determination of Requirements Related to the Product
7.2.2 Review of Requirements Related to the Product.
7.2.3 Customer Communication
7.3 Design and Development
7.3.1 Design and Development Planning
7.3.1.1 Multidisciplinary approach
7.3.2 Design and Development Inputs
7.3.3 Design and Development Plan Outputs
7.3.4 Design and Development Review
7.3.5 Design and Development Verification
7.3.6 Design Validation
7.3.7 Design Changes
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
7.5.2 Validation of Processes for Product and Service Provision
7.5.3 Identification, Traceability, and Final Product Serial Number Tracking.
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 Control of Monitoring and Measuring Equipment
7.6.1 Measurement Systems Analysis
7.6.2 Calibration / Verification Records
8 Measurement, Analysis, and Improvement
8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product
8.3 Control of Nonconforming Product
8.3.1 Control of Nonconforming Product‐ Supplemental
8.3.2 Control of Reworked Product
8.3.3 Customer Information
8.3.4 Customer Waiver
8.4 Analysis of Data
8.4 Analysis and use of Data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action