ISO 9001:2015 BACK TO THE FUTURE

Published by AuthorHouse

Book Title

The “Back” part of the title is the importance of understanding the restrictive role of ISO 9001 which, from the Attachment B “Back to Basics” within the book, would clearly indicate that there is little common understanding. The “Future” part of the book is the need to ensure it is used correctly and there are unfortunately many issues within the drafts of ISO 9001 and ISO 9000 that could give cause for concern.

ISBN: 978-1-4969-9807-1 (sc) ISBN: 978-1-4969-9809-5 (e)

***********************************

ISO 9001 Committee meeting September 2014

A motion for the standard to be taken to Final Draft International Standard (FDIS) was proposed and seconded. The committee voted in favour of the motion.

Members of the committee commented that the standard is extremely relevant and, at this stage, it is a case of “improving rather than changing”.

A representative of Federation of Small Businesses voiced concerns over the perceived under representation of SMEs in the draft. However, it was explained in the discussion that ISO 9001 is a generic standard that can be scaled according to meet the needs of any organization, regardless of size. It was suggested that the term organization and how this applies to SMEs could be included as a note.

This information is from BSI and sent out 5th December 2014 to BSI Members

***********************************

Generic Standard

The danger with any generic standard is that it can be misused and ISO 9001 “Scaled Down” comment would still leave concerns for Small to Medium size Enterprises (SME’s) and these concerns can be readily understood. The intention of this book is to allow SME’s and even larger organisations to control what affects their ability to meet the scope of ISO 9001 which has not changed as it is still about consistently achieving the customer requirements. ISO 9001is not intended to cover all the management system requirements an organisation has to deal with.

The committee comment that it is “improving rather than changing” is an admirable intention however the current use of ISO 9001 is inconsistent and this book highlights some of the concerns that allows these misunderstandings to thrive. In fact some opportunities are being missed in the drive to make change.

Website preview ISO 9001 Back to the Future December 2015

INDEX Page Section Description 1 Index 2 0.0 General 3 1.0 Introduction 6 2.0 Annex SL (New ISO format for standards) 12 3.0 ISO Standards, structure and awareness 18 4.0 “ISO 9001 Family of Standards” Summary 20 5.0 ISO 9000:2014 Fundamentals and Vocabulary (Draft) 23 6.0 ISO 9001:2008 Purpose and Scope 29 7.0 Issues within the “Introduction” of ISO 9001:2015DIS 37 8.0 Comparison between ISO 9001:2008 and 9001:2015DIS 45 9.0 Auditing 48 10.0 Improvement 57 11.0 Vocabulary and Definitions 64 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. 66 ATTACHMENT A ISO standards structure (reference section Sect 3) 71 ATTACHMENT B Back to Basics 10 LinkedIn questions 75 ATTACHMENT C Concerns raised at CQI Leadership Conference 77 ATTACHMENT D ISO (APG) ISO 9001 Audit Trail December 2009 80 ATTACHMENT E Structured selection of KEY issues 84 ATTACHMENT G Problem sheet 85 ATTACHMENT H Summary of Key concerns

Website preview ISO 9001 Back to the Future December 2015

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

ISO 9000 is the “Core” standard within the “ISO 9000 Family of standards”

Website preview ISO 9001 Back to the Future December 2015

Some examples from a few chapters 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. KEY - 5.1 Since 2011 revisions to the “ISO 9000 family of standards” no longer call up “ISO 9000 Fundamentals and Vocabulary” as a “Normative Reference”. This makes it difficult to understand the purpose of ISO 9000! In fact the whole role of ISO 9000:2005 is to provide a “Core” standard that explains quality management principles their controls and definitions. ISO 9000 retains the “Definitive” central control for fundamentals and vocabulary and when this is not used within the “ISO 9000 Family of Standards” it undermines the purpose and structure of the Family. ISO 9000 is the “Core” standard within the “ISO 9000 Family of standards”. Each of the other standards within the “Family” should call up ISO 9000 as a “Normative Reference” KEY 6.5 - Whenever the term “product” occurs within ISO 9001:2008 it can also mean “service”. (2008 Clause 3) ISO 9001:2015DIS Annex A Table B Major differences. (Product will now be Product and Services) Major? I think not. KEY 6.10 The term quality management system does NOT mean a documented management system as you can manage the system using competent personnel without resorting to writing a procedure or work instructions for everything. (6.2.2 & 4.2.1d) KEY 7.1 - Adding subjective issues such as “organizational Culture” and “Socio-economic” conditions when they are not relevant to the scope of ISO 9001 could undermine the purpose of ISO 9001 however clause 4.3 allows the organization to decide what is applicable. (see “Spiral of Scope”) KEY 7.3 - The most powerful tool to control and limit the possibility of subjective issues being introduced in ISO 9001:2015DIS is clause 4.3. This is because it is the responsibility of the “Organisation” to write an effective scope that would ensure their management system can consistently meet the customer specified requirements taking into account the restrictive role of ISO 9001. (See the Spiral of Scope below) KEY 7.4 - Including the ISO 31000 guidance standard on risk management in clause 0.5 is incorrect and has set a precedent as there are many different guidance standards and all of them are optional. It is up to the organization to decide if they wish to use them. The structure of quality related ISO standards should be identified in ISO 9000. (See attachment A in the book)

Website preview ISO 9001 Back to the Future December 2015

KEY - 8.1 The failure to recognise the important role of ISO 9000 has allowed many definitions to be changed without justification and ISO 9000 should be reinstated as a normative reference within ISO 9001:2015. (See definitions and ISO 9000 in this book) KEY - 8.2 Risk Management, which is specifically stated as NOT being applicable in ISO 9001:2008 clause 0.4, has been deleted from ISO 9001:2015CD and this is a significant change. KEY 9.1- To enable audits to achieve their purpose it requires the auditor to carry out a process audit following an audit trail of the samples chosen. The auditor needs to takes a selective sample of orders or contracts, review the requirements for each of the chosen samples then follow the selected samples to ascertain if the management system is able to consistently meet the specified requirements. KEY 9.2 - Two definitions should be added to ISO 9000:2014DIS if credibility is to be improved. They are “Audit Trail” and “Observation” these two fundamental terms should be applied when carrying out professional audits. KEY 11.2 - What is the purpose of removing 62 well established definitions from ISO 19011:2011 “Guidelines for Auditing Management Systems? Note: - The same approach is being used by ISO 9001:2015 but to a lesser extent KEY 11.4 - ISO 9001:2015DIS has dropped the definition for Objective evidence indicating it is the same as Audit evidence and this is incorrect. Note: - ISO 9000:2014DIS has two definitions for “Objective evidence” (3.8.4 and 3.10.15) I can only hope that 3.8.4 objective evidence – data supporting the existence or verity of something is validated. The belief that Audit Evidence and Objective evidence are the same is incorrect.

Website preview ISO 9001 Back to the Future December 2015

SPIRAL OF SCOPE (See section 2 Annex SL)

The figure 1 In ISO 9001:2015DIS shows that the clauses 4.0, 4.1, 4.2 and 4.3 come through the centre of the circle and into clause 4.4 relevant quality management system and processes and then into clause 5 Leadership this is a significant change. It is the interpretation that is needed by the Leadership within the organisation that will determine if these additions will be dealt with in a beneficial manner or will be used as a requirement regardless if it is applicable. (The so called “System Audit”)

The Author

Quality above and below David John Seear

Let this book be your co-pilot through the changes in order that you do not drown in

terminology that is not relevant to your organisations business