Iso 9001:2015 into the Future

By David John Seear

A review of the core Standards and how they should be interpreted when updating your quality management system to ISO 9001:2015.

This book is designed to allow any organisation to have an effective practical quality management system.

It explains a simple approach of how to implement the new ISO 9001:2015 certifiable standard in a manner that benefits the business.

The whole purpose of using the ISO standards is to help an organisation improve and control what they do.

• Language: English
• Publisher: AuthorHouse UK
• Release date: Nov 21, 2015
• ISBN: 9781504994293

David John Seear

David John Seear, CEng, CMarEng, FIMarEST, CQP, FCQI, is a chartered engineer who spent twelve years at sea, ending up as chief engineer with a combined first class chief engineers certificate before leaving and joining Shell UK. After twenty years at Shell UK, where he had been head of quality and performance for Shell UK Materials Services running the quality and performance department, one of the three departments reporting to him was quality appraisal, whose purpose was to carry out second-party audits. His final position with Shell was quality manager UMAQ. Took over the role of chairman of the Engineer and Equipment Materials Users Association (EEMUA) and represented the CBI on BSI QMS 22 for six years and represented the UK on ISO 9000 TC 176 for three years. Worked for Brunei Liquid Natural Gas as head of supplies and was regional manager for a certification body in the Middle East, where he was based in Abu Dhabi. Carried out audits and training throughout the world, including Africa, North and South America, Russia, Europe, Scandinavia, as well Singapore and Malaysia when he lived in the Far East and Pakistan, India, UAE, Jordan, Kuwait, and Bahrain when living in the Middle East He is an IRCA principal auditor of thirty years of experience and runs PDQ Management Services, carrying out training, auditing, consultancy, and lecturing on various management issues, including procurement and how to implement effective quality management systems. Note: All views within the book are the author’s own. E-mail” [e-mail] www.pdqms.co.uk

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ISO 9001:2015

INTO THE FUTURE

DAVID JOHN SEEAR

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AuthorHouse™ UK

1663 Liberty Drive

Bloomington, IN 47403 USA

www.authorhouse.co.uk

Phone: [phone]

First Edition 11th November 2015

Note:—This First edition was developed following the publication of ISO 9000 and ISO 9001 in September 2015 using the new ISO structure for certification standards known as Annex SL

This is the fourth book in a series of books that were initially developed from the publication of

Understanding the Audit Trail published by IRCA Inform Issue 24 on the 10th December 2009.

http://www.irca.org/en-gb/resources/INform/archive/issue24/

A similar article is also in www.iso.org/tc176/ISO9001AuditingPracticesGroup on the same date

The previous books:

- ISO 9001- 2015 Back to the future ISBN 978-1-4969-9807-1 (sc)

- ISO 9001- 2012 Audit Trail ISBN 978-1-4772-3489-1 (sc)

- ISO 9000 - 2012Family of Standards ISBN 978-1-4772-2640-7 (sc)

All the above books are available as e’books: -

ISO 9001:2014 Back to the future ISBN 978-1-4969-9809-5 (e)

ISO 9001 Audit Trail ISBN 978-0-9565100-0-6 (e)

ISO 9000 Family of Standards ISBN 978-1-4771-2640-4 (e)

It is intended that Certified Organisation, Certification Bodies and both Internal and External Auditors obtain benefit from the book ISO 9001:2015 Into the Future so users can improve their understanding of Annex SL on how it should be implemented following the issue of the ISO 9001standard in September 2015.

This document is generic and suitable for any organisation whether they are ISO 9001 Certified or

not. It gives guidance on the role of the standards in the new term Core standards (Was ISO 9000 Family of Standards) in ISO 9000:2005 and how ISO 9001:2015 should be used. It includes various proposals one of which is to publish a clear detailed structure for ISO Quality Standards.

The guidance notes, drawings, proposals may not be used or copied without approval.

© 2015 David Seear. All rights reserved.

No part of this book may be reproduced, stored in a retrieval system, or transmitted by any means without the written permission of the author.

Published by AuthorHouse 11/20/2015

ISBN: 978-1-5049-9428-6 (sc)

ISBN: 978-1-5049-9429-3 (e)

The imagery has been developed by the author and www.dabagency.co.uk for illustrative purposes.

Because of the dynamic nature of the Internet, any web addresses or links contained in this book may have changed since publication and may no longer be valid. The views expressed in this work are solely those of the author and do not necessarily reflect the views of the publisher, and the publisher hereby disclaims any responsibility for them.

Index

0.0 Introduction

1.0 Step 1 Overview of what should be considered

2.0 Step 2 ISO 9001:2015 clause 4 Context of an organisation

3.0 Annex SL New ISO structure for standards

4.0 ISO Standards, Structure and Awareness

5.0 ISO 9000:2015 Fundamentals and vocabulary

6.0 Step 3 ISO 9001:2015 other relevant modifications

7.0 Auditing

8.0 Improvement

9.0 Vocabulary and Definitions

10.0 Revisions to procedures and standards

11.0 Quality Manuals and How They May Help

12.0 Conclusion

Opinions are those of the author and may not be accepted by all parties.

Attachment A

Attachment B

Attachment C

Attachment D

Attachment E

Attachment F

Attachment G

0.0 Introduction

All the views in this book are the author’s and are an attempt to help users have a common understanding of the benefits of the ISO Standards. Since each section is standalone, there is inevitably some repetition between the various sections.

This book does NOT recommend rushing to make changes to your quality management system. It emphasises that the revision to ISO 9001 was driven by the new structure for ISO certifiable standards using the common ISO format Annex SL. Any change made should be carried out in a planned and well thought out manner. As the scope has not changed and provided your organisation already operates by the spirit of ISO 9001:2008 then the change to ISO 9001:2015 should be straightforward.

The revision to ISO 9001:2015 was driven by the need to use the ISO Annex SL structure to allow easy integration of Certifiable standards within an organisation’s management system.

The book also introduces the wider structure and purpose of the many ISO standards using the flying saucer approach. It reminds all users of the structure and purpose of the Core Standards and references the importance of the supporting Requirement Standards, Guidance Standards and Related Standards and how these standards and other reference documents should be used if quality is to gain credibility following the issue of ISO 9000:2015 and ISO 9001:2015.

ISO 9001 is one of the best known ISO certified standards. However, it is just one standard within the Core Standards. It specifies requirements for a quality management system from agreeing with the customer what they require to delivering the product or service to those requirements. It also covers the related supporting activities where they can affect the intended outcome of meeting customer requirements.

ISO 9001 Certification was introduced to give confidence to both the organisation, and their customers that the management system being used is capable of consistently achieving the customer requirements. It is true that ISO 9001, being a basic generic standard, is capable of being used across all of an organisations business activities and any organisation NOT using the ISO 9001 clauses across all of their business activities is missing out on a very effective management tool. That said the important thing is to recognize when ISO 9001 clauses are being used outside their restrictive scope, especially when carrying out Certification audits.

This restrictive scope allows certification bodies to take a selective sample of orders, find out the requirements for those orders, then audit to see if the quality management system being used is able to consistently meet the customer requirements. It ensures that ISO 9001 certification can be totally objective as it is judged against its ability to meet the actual customer requirements. This must be understood by all parties if improvement is to take place as there seems to be little common understanding at present.

ISO 9001:2015 is the opportunity to put this right.

0.1 Summary covering ISO 9001:2015

This short summary has been put together to help busy people identify what they need to consider. You will note that the examples have been taken, not only from the Quality Management system – requirements, but selected parts of the Introduction and Annex within ISO 9001:2015. The reason for this is there are many points of clarification within the Introduction and the Annex and it is important to understand these advisory points before trying to modify your Quality management system. This is important if you are to use the standard in its correct context and ensure the changes benefit your business. In many cases ISO 9001:2015 will not require a massive change in your quality management system provided the organisation already operates to the spirit of ISO 9001:2008. In fact ISO 9001:2015 has been introduced in order to get Back to Basics and improve the understanding of what an ISO 9001 QMS should achieve, which is to consistently provide product and service to the customers specified requirements.

1. Do not rush to make changes. You have three years to carry out a full crossover to ISO 9001:2015. Think before you make changes. (Ask yourself will this benefit my business?)

2. Don’t just try to just use a comparison from clauses 4 – 8 in ISO 9001:2008 against clauses 4 – 10 in ISO 9001:2015 without looking at the Introduction and Annex sections. (See below)

3. Clause 1 to 3 are basically the same as before as the scope has not changed and clause 2 still identifies ISO 9000:2015 as being indispensable to the application of ISO 9001:2015.

4. ISO 9001:2015 states that it is not the intention to imply the need to align the structure of clauses to the new clause numbering or to use the terminology being used in 2015.

(Clause 0.1 General) So there is no need to rewrite your system to suit ISO 9001:2015.

5. There are now only 7 management principles instead of the 8 referenced in ISO 9000:2005 where clause 0.2 e) System approach to management has now been removed. I can find no logical reason why this should have happened.

6. Plan, Do, Check and Act (PDCA) is still applicable (Clause 0.3.2)

7. The new standard indicates that the concept of Risk Based Thinking has been implicit in previous editions of ISO 9001 so it is not new. (Clause 0.3.3)

8. There are now just three standards in the ISO 9000 Family of Standards now called Core standards ISO 9000:2015, ISO 9001:2015 and ISO 9004:2009. (ISO 9001:2015 Annex B)

9.