QA-2 ISO9001-2015-English

QUALITY MANAGEMENT
SYSTEM ISO9001:2015
Iwan Harianton, B.Sc., M.Eng
Senior Lecturer in Manufacturing System & Development
POLMAN Bandung Jl. Kanayakan No. 21 Bandung 40135
The new ISO 9001:2015
The new ISO 9001:2015: key differences and

impact in the organizations
Edition: June 2015

1. Introduction
A short overwiew of ISO 9001 in the world
1. Introduction
1. Introduction
1. Introduction
2. Why ISO 9001 is being revised
All ISO management system standards are

subject to a regular review under the rules by
which they are written. Following a substantial
user survey the ISO Committee responsible for
ISO 9001 decided that a review was appropriate
and created the following objectives to maintain
its relevance in todays market place:
Maintain relevance
Integrate with other management systems / standards
Provide an integrated approach to organizational
management
Provide a consistent foundation for the long-term (next
10-25 years)
Increase adoption of the standard
Address increasing complexity of business
environment (e.g. non-office/virtual office)
Address increased variety of business users (e.g.
service industries; office environments)
Enhance an organizations ability to satisfy its
customers.
2.1 The Common Framework

Standardize and effectively develop standards
Enhance alignment and compatibility of
standards
Useful for organizations which pursue multiple
standards
Some standards already under Common
Framework: ISO 22000, ISO 20001, ISO 50001
Under revision to the Common Framework: ISO
14001, ISO 27001, ISO 9001
ISO 9001:2015
3.1. What is changing? 0. Introduction
ISO 9001:2008 1. Scope
0. Introduction 2. Normative References
1. Scope 3. Terms and Definitions
2. Normative References 4. Context of the
3. Terms and Definitions
Organization
4. Quality Management System 5. Leadership
5. Management Responsibility 6. Planning
6. Resource Management 7. Support
7. Product Realization 8. Operations
8. Measurement, Analysis and 9. Performance
Improvement Evaluations
10.Improvement
ISO 9001:2015 will be based on Annex SL the new

high level structure (HLS) that brings a common
framework to all management systems. This helps to
keep consistency, align different management system
standards, offer matching subclauses against the top-
level structure and apply common language across all
standards. Based on the PDCA approach, ISO
9001:2015 will follow this structure. With the new
standard in place, organizations will find it easier to
incorporate their quality management system into the
core business processes and get more involvement
from senior management.
4. What are the significant proposed changes?

1. The emphasis on leadership
2. Organizational Context
Responsiveness to business environment
3. The focus on risk based management
Preventive action
4. Emphasis on objectives, measurement and
change
5. Increase emphasis on achieving value for
organization and its customers
6. Communication and awareness
Others:
7. Fewer prescriptive requirements.
8. Documented Information
Decreased emphasis on documentation
9. Outsourcing is now External Provision
10. No requirement for Management
Representative
11. No requirement for Quality Manual
4.1. Leadership and organizational context

Firstly, the organization will need to determine external and
internal issues that are relevant to its purpose, i.e. what are
the relevant issues, both inside and out, that have an
impact on what the organization does, or that would affect
its ability to achieve the intended outcome(s) of its
management system.
It should be noted that the term issue covers not only
problems, which would have been the subject of preventive
action in previous standards, but also important topics for
the management system to address, such as any market
assurance and governance goals that the organization
might set for its management system.
This means that senior managers need to be able to

demonstrate an understanding of the wider business
environment, social, cultural and regulatory and how that
impacts or could impact on the organizations ability to
meet customer requirements.
In the same context they need to have a grasp of the

organizations internal strengths and weaknesses and how
these could impact on the ability to deliver their products or
services.
This will strengthen the concept of business process

management including the need now to allocate specific
responsibilities for processes, and demonstrate an
understanding of the key risks associated with each
process and the approach taken to manage, reduce or
transfer the risk.
Top management now have a greater involvement in the

management system. They have to make sure that the
requirements of the management system are integrated
into the organizations processes and that the policy and
objectives are compatible with the strategic direction of the
organization.
4.2. Focus on risk based management

Senior management must be able to demonstrate an
understanding of business risks and how they could impact
on the ability to meet customer requirements. An effective
risk management process will be critical for successful
certification to the new version.
It must ensure the management system can achieve its

intended outcomes and achieve continual improvement.
Clause 6.1 Actions to address risks and opportunities, is
where this is covered and it addresses the what, who, how
and when of risk management.
The organization should plan actions to address these

risks and opportunities, how to integrate and implement the
actions into its management system processes and
evaluate the effectiveness of these actions.
Risk management replaces preventive action. Organisation

will need to identify where risk arises and ensure controls
are in place to manage it. Remember that risk is defined as
the effect of uncertainty on an expected on result and the
new standard makes risk-based thinking more explicit
throughout.
4.3. Objectives and measurement
The requirements around quality objectives have also been

made more detailed. They need to be consistent with the
quality policy, measurable (if practicable), monitored,
communicated, and updated as appropriate. They also
have to be established at relevant functions and levels.
Objectives should include plans on how to achieve them as

well as how the results will be evaluated.
The organization must determine who will be responsible

for the delivery of the objectives, resources required, what
needs to be done and by when.
So remember that when establishing quality objectives

organization needs to demonstrate how they plan to
achieve them. And remember that the objectives (results to
be achieved) can be technical, strategic or operational.
4.4. Communication and awareness

Clause 7.3 Awareness is now a clause in its own right:
people working under an organizations control should be
aware of the quality policy, objectives, their contributions to
QMS, implications of non-conformities etc. There is an
increased emphasis on awareness to ensure that everyone
knows the implications of not conforming to the
management system requirements.
Which leads into Clause 7.4 Communication internal

and external communications are now a requirement. Its
up to the organisations to decide what/who/when and how
they are communicating. Communication is important for
both internal and external stakeholders and an
organization must develop a communication plan. It is
important to decide who will own the communication and
ensure that they have the appropriate authority,
competencies and knowledge.
The communication plan can include a variety of mediums

including briefings, meetings, seminars, conferences and
newsletters.
4.5. Fewer prescriptive requirements

Much will be made of the fact that the new version of the
standard has no requirements for procedures but it does
have requirements for documentation. Clause 7.5
Documented Information deals with documented
information and is split into 3 sub-clauses general,
creating and updating and control.
An organization must decide what information they wish to

retain, how these are updated and controlled and
adequately protected Clause 8 Operations includes:
Requirements for customer communication (from
information on products to contracts and invoicing)
Review of design and development changes
Information for external providers
Identification and traceability
Release of products and services now part of
operational controls
Non-conforming processes, outputs and product and
services
5. High Level Structure New Clause Numbers
1. Scope
2. Normative References
3. Terms and Definitions
4. Context of the Organization
4.1. Understanding the Organization and its context
4.2. Needs and expectations
4.3. Scope
4.4. Management system
5. Leadership
5.1. Management commitment
5.2. Policy
5.3. Roles, Responsibility and Authority
6. Planning
6.1. Actions to address risks and opportunities
6.2. Objectives and plans to achieve them
7. Support
7.1. Resources
7.2. Competence
7.3. Awareness
7.4. Communications
7.5. Documented Information
8. Operations
8.1. Operational planning and control
9. Performance evaluation
9.1. Monitoring, measurement, analysis and
evaluation
9.2. Internal audit
9.3. Management review
10. Improvement
10.1. Nonconformity and corrective action
10.2. Continual improvement
6. Some Requirements Examples
4. CONTEXT OF THE ORGANISATION
4.1. Understanding the organization and its context

The organization must determine external and internal
issues relevant to its purpose and that affect its ability to
achieve the intended outcome(s) of its QMS.
4.2. Understanding the needs and expectations of

interested parties
The organization must determine interested parties
relevant to the QMS, and the requirements of these
interested parties
List of interested parties the organization must consider:
Direct customers
End users
Suppliers, distributors, retailers or others involved in
the supply chain
Regulators, and
Any other relevant interested parties
4.4. Quality management system
The organization must establish, implement, maintain and

improve a QMS, including the processes needed and their
interactions, in accordance with the requirements of this
standard
"Process approach" is maintained, and it will be embedded
in all ISO management system standards.
5.1. Leadership
Top management must demonstrate leadership and
commitment with respect to the quality management
system, by ...
Ensuring the integration of the QMS requirements
into the organization's business processes,
Promoting awareness of the process approach,
Supporting other relevant management roles to
demonstrate their leadership as it applies to their
areas of responsibility.
Top management must demonstrate leadership and
commitment with respect to customer focus.
6.1. Actions to address risks and opportunities
When planning for the QMS, the organization must
consider the issues... in 4.1 and the requirements ... in 4.2
and determine the risks and opportunities that need to be
addressed to:
Assure the QMS can achieve its intended outcome(s)
Prevent or reduce undesired effects
Achieve improvement
The organization must plan:
Actions to address these risks and opportunities, and
how to:
Integrate and implement the actions into its OMS
processes and
Evaluate the effectiveness of these actions
7.1. Resources
The organization must determine and provide the
resources needed for the OMS (establishment,
implementation, maintenance and improvement of the
OMS).
Resources may include:
Infrastructure (7.1.2 )
Process environment (7.1.3)
Monitoring (7.1.4 )
Knowledge (7.1.5)
8.1. Operational Planning and Control
The organization must plan, implement and control the

processes needed to meet requirements and to implement
the actions determined in 6.1, by:
Establishing criteria for those processes
Implementing the control of the processes in
accordance with the criteria
Keeping sufficient documented information to
demonstrate the processes have been carried out as
planned
The organization must control planned and review the

consequences of unintended changes, taking action to
mitigate any adverse effects, as necessary.
The organization must ensure the operation of a function

or process of the organization by an external provider is
controlled (outsourcing ).
8.4. Control of External Provision of Goods and

Services
The organization must ensure that externally provided
goods and services satisfy the specified requirements.
Note: These include outsourcing.

9. PERFORMANCE EVALUATION
9.1. Monitoring, measurement, analysis and evaluation
9.2. Internal audit
9.3 Management review

10. IMPROVEMENT
10.1. General
10.2. Non Conformity and Corrective Action
10.3 Continual Improvement

7. The revision and transition plan
May 2014 The Draft International Standard (DIS) is

made available for public comment
July 2015 The Final Draft International Standard (FDIS).
September 2015 The International Standard is published
September 2018 The transition is complete

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QUALITY MANAGEMENT

The new ISO 9001:2015: key differences and

Edition: June 2015

2. Why ISO 9001 is being revised

All ISO management system standards are

2.1 The Common Framework

ISO 9001:2015 will be based on Annex SL the new

4. What are the significant proposed changes?

4.1. Leadership and organizational context

This means that senior managers need to be able to

In the same context they need to have a grasp of the

This will strengthen the concept of business process

Top management now have a greater involvement in the

4.2. Focus on risk based management

It must ensure the management system can achieve its

The organization should plan actions to address these

Risk management replaces preventive action. Organisation

4.3. Objectives and measurement

The requirements around quality objectives have also been

Objectives should include plans on how to achieve them as

The organization must determine who will be responsible

So remember that when establishing quality objectives

4.4. Communication and awareness

Which leads into Clause 7.4 Communication internal

The communication plan can include a variety of mediums

4.5. Fewer prescriptive requirements

An organization must decide what information they wish to

5. High Level Structure New Clause Numbers

6. Some Requirements Examples

4. CONTEXT OF THE ORGANISATION

4.1. Understanding the organization and its context

4.2. Understanding the needs and expectations of

4.4. Quality management system

The organization must establish, implement, maintain and

8.1. Operational Planning and Control

The organization must plan, implement and control the

The organization must control planned and review the

The organization must ensure the operation of a function

8.4. Control of External Provision of Goods and

Note: These include outsourcing.

9.1. Monitoring, measurement, analysis and evaluation

9.2. Internal audit

9.3 Management review

10.2. Non Conformity and Corrective Action

10.3 Continual Improvement

7. The revision and transition plan

May 2014 The Draft International Standard (DIS) is

July 2015 The Final Draft International Standard (FDIS).

September 2015 The International Standard is published

September 2018 The transition is complete

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