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Manual 1

The document summarizes the key changes between ISO 9001:2008 and ISO 9001:2015 standards. Some major changes include adopting a common high-level structure and terminology, greater emphasis on leadership involvement and risk-based thinking, explicit consideration of interested parties' needs and context of the organization, replacement of preventive action with risk and opportunities.

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18 views

Manual 1

The document summarizes the key changes between ISO 9001:2008 and ISO 9001:2015 standards. Some major changes include adopting a common high-level structure and terminology, greater emphasis on leadership involvement and risk-based thinking, explicit consideration of interested parties' needs and context of the organization, replacement of preventive action with risk and opportunities.

Uploaded by

cetutilities
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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TUV INDIA TRAINING ACADEMY

ISO 9001:2015

INTERNAL AUDITOR TRAINING


COURSE

DELEGATE MANUAL

TUV INDIA PRIVATE LIMITED

801, Raheja Plaza-1, L.B.S.Marg, Ghatkopar (W), Mumbai - 400 086.Tel: 022 6647 7000

E-mail : [email protected] Website : www.tuv-nord.com/in

QMS IA ( 01-002) Rev 06 May 2022 Page 1 of 42


TUV INDIA TRAINING ACADEMY

CONTENTS

1. Title page………………………………………………………………………………………..1

2. Contents………………………………………………………………………………………...2

3. Chapter 1: History & revision updates……………………………………………………….3

4. Chapter 2 : Quality Management Principles………………………………………………...7

5. Chapter 3 : Process Approach………………………………………………………………10

6. Chapter 4 : Risk Based Thinking……………………………………………………………11

7. Chapter 5 : Compatibility of ISO 9001:2015 with other MSS


And ISO 9001:2015 Contents…………………………………………………13

8. Chapter 6 : Documented Information and Key terms and definitions………...……..…15

9. Chapter 7 : Management Systems Auditing.………………………………………………21

10. Chapter 8 : Auditor Competence and Evaluation .…………..……………………………40

QMS IA ( 01-002) Rev 06 May 2022 Page 2 of 42


TUV INDIA TRAINING ACADEMY

Chapter 1 : History & Revision Updates

Overview of changes to ISO 9001


 Standard produced by ISO Technical Committee (TC-176),
 First edition released in 1987,
 1st revision published in 1994,
 2nd revision published in 2000,
 3rd revision published in 2008
 4th revision Published on 15th Sept.2015.

QMS IA ( 01-002) Rev 06 May 2022 Page 3 of 42


TUV INDIA TRAINING ACADEMY

Summary of principal changes – ISO 9001:2008 to ISO 9001:2015

1. The revised standard in 2015 adopts the high-level structure and terminology of Annex SL.
Annex SL was developed to ensure all future ISO management system standards would
share a common format, irrespective of the specific discipline to which they relate. Annex
SL prescribes a high level structure, identical core text, and common terms and definitions.

2. Clause 5 : Previously “Management Responsibility”, now becomes “Leadership”. Top


management is required to demonstrate that they engage in key quality management
system activities as opposed to simply ensuring that these activities occur. This means that
there is a need for top management to be actively involved in the operation of their quality
management system. The removal of all references to the role of “Management
Representative” reinforces a desire to see quality management systems embedded into
routine business operations, rather than operating as an independent system in its own
right with its own dedicated management structure.

3. Two new clauses (4.1 and 4.2) are introduced relating to the context of the organisation.
Organisations will be required to identify explicitly any internal and external issues that may
impact their quality management system’s ability to deliver its intended results. They must
also understand the needs and expectations of “interested parties” – those individuals and
organisations that can affect, be affected by, or perceive themselves to be affected by, the
organisation’s decisions or activities.

4. ISO 9001:2015 places a greater emphasis on the definition of scope of the quality
management system than ISO 9001:2008 does. Scope sets the boundaries for, and
identifies the applicability of, an organisation’s quality management system. Clause 4.3
requires scope to be determined in consideration of the organisation’s context.

5. While ISO 9001:2008 promoted the adoption of a process approach when developing,
implementing and improving the effectiveness of a quality management system, clause 4.4
of ISO 9001:2015 sets out specific requirements designed to enforce its adoption.

6. References to preventive action have disappeared – however, the core concept of


identifying and addressing potential mistakes before they happen very much remains. ISO
9001:2015 now talks in terms of risk and opportunities. Organisations must evidence that
they have determined, considered and, where necessary, taken action to address any risks
or opportunities that may impact (either positively or negatively) their quality management
system’s ability to deliver its intended outcomes or that could impact customer satisfaction.

7. The term “product” will be replaced by “products and services”. Previously, the inclusion of
services as products was implicit. By including explicit reference to services, the standard
is attempting to reinforce that ISO 9001 is applicable to all organisations, not just those that
provide physical products.

8. ISO 9001:2015 clause 10 recognises that incremental (continuous) improvement is not the
only improvement profile. Improvement can also arise as a result of periodic
breakthroughs, reactive change or as a result of reorganisation. Thus, the title of this clause
is now “Improvement” (ISO 9001:2008 8.5.1 referred to “Continual improvement”).

9. The phrase “externally provided products and services” replaces “Purchasing”. Clause 8.4
addresses all forms of external provision, whether it is by purchasing from a supplier,
through an arrangement with an associate company, through the outsourcing of

QMS IA ( 01-002) Rev 06 May 2022 Page 4 of 42

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