Iso 9001: 2015 Back to the Future: A Review of the New Iso Annex Sl Structure for Certification Standards Using the Draft Iso 9001: 2015 to Explain the Changes.

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First Edition 10th December 2014

Note:—This First edition was developed following the revision to ISO 9001 using the new ISO structure for certification standards known as Annex SL Both ISO 9000 and ISO 9001 are to be published in 2015 with ISO 9001:2015 being introduced using the new format.

This is the third 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.pdqms.co.uk/documents/Understanding%20the%20audit%20trail.pdf

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

The previous books: -

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

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

Both are also available as e’books: -

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 Organisation, Certification Bodies and both Internal and External Auditors obtain benefit from ISO 9001:2015 Back to the Future so they can improve their understanding of Annex SL and how it should be used following revisions to ISO standards from 2015.

This document is generic and suitable for any organisation whether they are ISO 9001 Certified or not, as it gives guidance on the role of the standards in the ISO Family of Standards as defined in ISO 9000:2005 and how ISO 9001 should be used. It includes various proposals one of which is to publish a clear detailed structure for ISO Quality Standards.

The guidance notes, proposals and new definitions may be used as individual training notes to help

Organisations improve.

© 2014 David John 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 10/12/2014

ISBN: 978-1-4969-9807-1 (sc)

ISBN: 978-1-4969-9809-5 (e)

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

Index

0.0 General Background

1.0 Introduction

2.0 Annex SL New ISO structure for standards

3.0 ISO Standards, Structure and Awareness

4.0 ISO 9001 Family of Standards Summary (From book of same name)

5.0 ISO 9000:2014 Draft Fundamentals and vocabulary

6.0 ISO 9001:2008 Purpose and scope

7.0 Issues within the Introduction section of ISO 9001:2015DIS

8.0 Comparison between ISO 9001:2015DIS and ISO 9001:2008 requirements.

9.0 Auditing

10.0 Improvement

11.0 Vocabulary and Definitions

12.0 Conclusion

Note: - The above definitions clause 11.0 includes an attempt to get common terms not already defined put into ISO 9000 or even ISO 9000:2015 to ensure a better understanding.

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

Attachment A ISO standards structure (reference section Sect 3)

Attachment B Back to Basics 10 LinkedIn questions

Attachment C Concerns raised at CQI Leadership Conference

Attachment D ISO (APG) ISO 9001 Audit Trail December 2009

Attachment E Structured selection of KEY issues

Attachment G Problem sheet

Attachment H Summary of Key concerns

About the Author

The Author

0.0 General Background

This is the third book in a series of books attempting to improve the credibility of Quality by highlighting the pivotal role of the ISO 9000 Family of Standards.

This improvement process began on the 10th December 2009 with the publication of two similar articles entitled ISO 9001 Audit Trail, one published by IRCA Inform Issue 24 and the other by ISO 9001 Auditing Practices Group (APG). (See Attachment D)

This led to the first edition of a book titled ISO 9001 Audit Trail published in March 2010. This has now been superseded by a 2nd edition of ISO 9001 Audit Trail November 2012.

The book explains how audits cannot be effective if auditors do not understand what the output from a process should be. It championed the importance of carrying out process audits following an audit trail. Although Audit Trail has been recognized by many, including the International Register of Certificated Auditors (IRCA), ISO 9001 Auditing Practices Group (APG) and the United Kingdom Accreditation Service (UKAS), the draft revision to both ISO 9001 and ISO 9000 due to be issued in 2015 has failed to include a definition for Audit Trail.

This book highlights the importance of structuring the ISO certifiable standards into a common format using Annex SL. This approach will allow easy integration of Certifiable standards within any organizations management system if applied correctly.

It reminds all users of the structure and purpose of the ISO 9000 Family of Standards and references the importance of the supporting Requirement Standards, Guidance Standards and Related Standards and how these standards and other reference documents could be re-launched in 2015 through the revision of ISO 9000 and ISO 9001.

ISO 9000 FAMILY OF STANDARDS

The Core standard within the ISO 9000 Family of standards is ISO 9000 itself.

1.0 Introduction

This book is intended to remind everybody what the changes to the ISO 9000 Family of Standards in 2015 could achieve providing the restrictive role of ISO 9001 is understood.

ISO 9001 is one of the best known standards however it is just one standard within the ISO 9000 Family of 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. All views are the authors and are an attempt to help organisations understand the benefits of the ISO 9000 Family of Standards.

ISO 9001 Certification was introduced to give confidence to both the organization, and their customers that the management system being used is capable of consistently achieving the customer requirements. It goes on to state that within ISO 9001 the term product only applies to product or service intended for or required by the customer. ISO 9001 only covers the statutory and regulatory requirements that the product or service has to comply with, not everything the organisation has to comply with.

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 its restrictive scope when carrying out Certification audits.

KEY 1.1

It is true that the tools, (Clauses) within ISO 9001 may be used by the organization across all of their management activities however, when it is used beyond the restrictive scope of ISO 9001 it can cause confusion. The failure to understand and recognize when ISO 9001 is used outside its intended scope is the primary cause of misunderstanding.

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 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.

KEY 1.2

The primary purpose of ISO 9001 certification is to allow both the organization and their customers to have confidence that the quality management system being used can consistently provide product or service that meets the customer/specified requirements.

Most organisations will recognise the importance of meeting customer requirements and that is exactly what ISO 9001 was introduced to achieve. If ISO 9001 Certification does not achieve this assurance then the credibility of having a quality management system is undermined.

KEY 1.3

Making changes to ISO 9000 and ISO 9001 in 2015 without having a common understanding of their roles within quality could confuse rather than assist and promote the benefits of quality. (See Attachment B, 10 Back to Basics questions)

1.2 Application

This document explains the purpose of certification using ISO 9001 as the example. It highlights numerous concerns and explains, using ISO 9001 certification, what ISO Certification is all about and highlights areas of confusion. It may be used as a reference document to help understand, in a practical manner, how to use the ISO 9000 Family of Standards and the supporting standards. The structure of the standards includes the ISO 9000 Family of Standards (Core), Requirement Standards (R), Guidance Standards (G) and Related Standards (R) that help organisations manage their activities. (See Section 4.0 of this book). This is a generic book that is hoped will help any organisation revisit the original intended purpose of all the ISO Series of standards as identified in Attachment A to ensure that they make the most of what already exists without having to deal with extra requirement being forced into ISO 9001 when they are effectively covered within ISO guidance standards.

ISO 9001 has a specific role and is the quality standard that organisations can be certified to and there should be common understanding about the restrictive scope and what this means.

If all quality professionals had the same understanding it would prevent vested interest forcing their own requirements into certification standards thereby changing the scope