Draft Sample ISO 9001:2015 Into the Future (KIS) October Annex SL (New ISO format for standards)

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1 INDEX Page Section Description 1 Index Introduction and Summary KIS Step KIS Step Annex SL (New ISO format for standards) ISO Standards, structure and awareness ISO 9000:2015 Fundamentals and Vocabulary ISO 9001:2015 Quality Requirements Purpose and Scope Auditing Improvement Vocabulary and Definitions Revisions to procedures and standards Conclusion 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 Summary of what should be considered re ISO ATTACHMENT D ISO (APG) ISO 9001 Audit Trail December ATTACHMENT E Context check list 84 ATTACHMENT G Problem sheet 85 ATTACHMENT H Summary of Key concerns 1

2 0.0 Introduction All the views in this book are the authors and are an attempt to help users have a common understanding of the benefits of the ISO Standards. This book does NOT recommend rushing to make changes to your quality management system. It highlights that the revision to ISO 9001 was driven by the new structure for ISO certifiable standards using the common format Annex SL. Any change made should be carried out in a planned and well thought out manner. It reminds everyone that the scope has not changed and if you, as an organization, already operate 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 organizations 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 regain 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 organization, 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 its 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. THE TERM KIS = KEEP IT SIMPLE 2

3 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 from, not only 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 this revision, to ISO 9001:2015, has been introduced to get back to basics and improve the understanding of what an ISO 9001 QMS should achieve and that is to consistently provide product and service to the customers specified requirements. 1. Don t 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: 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 (Clause 0.1 General) So there is no need to rewrite your system to suit ISO 9001: 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. The biggest terminology changes are in clause 4.1 Understanding the organisation and its context and 4.2 Understanding the needs and expectations of interested parties. This is a good place to start. A method of doing this would be to revise your quality manual in a Draft format to include what they mean. (Do not start by making changes to your system) (See Spiral of Scope in this book) 3

4 0.2 Basic facts to facilitate improvement This summary is aimed at ensuring organizations are not disadvantaged and actually gain from the changes by going Back to Basics. Rewriting the quality management system and changing the documented system to reflect the new clause numbers will achieve little or nothing unless there is a better understanding of what ISO 9001 is all about. ISO 9001 does not cover all of an organizations quality management issues. This summary explains what the Core standards, previously known as the ISO 9000 Family of Standards is all about. The ISO 9001:2015 Core Standards From Annex B The core standards, containing the three standards above, are the high level standards that cover all of an organization quality management system. This should help to illustrate that ISO 9001 has a restrictive role covering the quality management system that is used to ensure the organization can consistently meet the customer requirements. ISO 9004 Managing for sustained success is the standard that covers all the other requirements outside the scope of ISO ISO 9000 previously known as the Core standard is used as a Normative reference by both ISO 9001 and ISO 9004 as well as by quality and auditing standards as it controls the Fundamentals and vocabulary to ensure all the standards use the same terms and definitions. The failure to understand and recognize what the ISO 9000 Family of Standards, now termed the Core standards, mean has been a principle reason why ISO 9001 has been misunderstood. Having been a trainer for decades when 70% of students, many of whom have been in quality for many years even a decade or more, have never heard of ISO 9000 or ISO 9004 this is a concern. It is important to recognize that the training has not been as effective as it should be. This is particularly true when ISO 9001 clause 2 Normative References has stated that ISO 9000 is indispensable to the application of ISO 9001:2008 and ISO 9001:2015 so this is not new. 4

5 1.0 STEP 1 KIS overview of what should be considered The majority of changes are in clauses 4-10 because: - Clause 1 The new standard is basically the same as ISO 9001:2008 except clause 1.2 Application in ISO 9001:2008 has been removed so there is now no comment on exclusions Clause 2 Normative References Is the same and indicates that ISO 9000 is indispensable to the application of ISO 9001 Clause 3 Terms and definitions Again just references ISO 9000:2015 So the first three clauses have not changed. The importance of clauses 1 3 and the Introduction as well as the Annexes cannot be over emphasized. The statement that ISO 9001 certification audits only need clauses 4 10 to be applied is wrong and just supports the so called System Audit. It is important that audits should be process audits where auditors take the time to find out what the output of the processes should be. a) Do not rush to change your management system. Do it in stages. b) Obtain a copy of ISO 9000:2015 and ISO 9001:2015 to see what they state. c) When you have ISO 9001:2015 read the Introduction and Annexes FIRST. d) Consider using your Quality manual to manage the changes. This is explained within this book e) Do NOT revise your system to match the clauses of the new standard as it is pointless and of little or no benefit. (Clause 0.1 General ISO 9001:2015) f) Clause 4 Context of an Organisation. Start with the Spiral of Scope in section 2.0 of this book where this is introduced then move onto Chapter 6. g) Clause 4.1 Understanding the organization and its context. The term context means nothing more than: - The circumstances that form the setting for the event, statement or idea (Oxford English dictionary) The organization, probably takes your setting into account already. What the standard will want you to do is demonstrate that you have taken into account both positive and negative factors that could affect your ability to meet the customer requirements. Chapter 6 covers this in detail. h) Clause 4.2 Understanding the needs and expectations of the interested parties. This will, if not controlled effectively, cause confusion. This clause mentions interested parties that are relevant to the QMS and the requirements of these interested parties. The Key issue here is whether these interested parties can affect your QMS from consistently meeting the customer requirements? Remember ISO 9001 has a restrictive scope. 5

6 i) Clause 6.1 Risk and opportunity. Remember that Annex SL is a generic format for the structure of ISO standards. The standard has been developed to suit the needs of 6