9 1.0 Step 1 Overview of what should be considered Step 2 ISO 9001:2015 Context of an organisation

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1 INDEX Page Section Description 1 Index Introduction and Summary Step 1 Overview of what should be considered Step 2 ISO 9001:2015 Context of an organisation Annex SL (New ISO format for standards) ISO Standards, structure and awareness ISO 9000:2015 Fundamentals and Vocabulary Step 3 ISO 9001:2015 other relevant modifications Auditing Improvement Vocabulary and Definitions Revisions to procedures and standards Quality Manual and how it could help Conclusion Opinions are those of the author and may not be accepted by all parties. 56 ATTACHMENT A ISO standards structure (reference section Sect 3) 61 ATTACHMENT B Back to Basics 10 LinkedIn questions 65 ATTACHMENT C Summary of what should be considered re ISO ATTACHMENT D ISO (APG) ISO 9001 Audit Trail December ATTACHMENT E Context check list 72 ATTACHMENT F Problem sheet 73 ATTACHMENT G ISO 9001:2015 Analyses and guidance 1

2 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. 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, 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: 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 organisations are not disadvantaged by the changes, but actually gain from the changes by going Back to Basics. Rewriting the quality management system and changing the documented system to reflect the ISO 9001:2015 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 organisations quality management issues. This summary explains what the Core standards, previously known as the ISO 9000 Family of Standards are and what they are all about. The ISO 9001:2015 Annex A Core Standards 2015 PDQMS The core standards, containing the three standards above, are the high level standards that cover all of an organisation 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 organisation 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 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 both ISO 9001:2008 and ISO 9001:2015. It is hoped that following this revision the normative reference will not be overlooked again. 4

5 If the role of ISO 9000:2005 had been recognized as being indispensable to the use of ISO 9001 it would have allowed students to know that ISO 9001 is one part of a Family of Standards. Thankfully the new ISO 9001:2015 has recognized the Family but revised the term and it is now known as the Core standards containing ISO 9000, ISO 9001 and ISO The revised term of Core standards is no longer mentioned in ISO 9000 but it is identified in ISO 9001:2015 Annex B. This failing has been compounded by the so called System Audit where certification bodies have been advised that ISO 9001 audits are to ensure that an organisation has a quality management system that covers the clauses in ISO This term System Audit was explained to me by a committee member as being: - ISO 9001:2008 audits are NOT to see if the organisations management system can consistently achieve the product or service required but to see if they have a management system that meets the requirements of clauses 4 8 of ISO 9001:2008. It is up to the organisation to see if the system is effective. This must be WRONG? The whole idea of having an ISO 9001 QMS is to ensure you can consistently provide products and services that meet the customer needs. If certification auditors do not know what the outcome of the process should be how can they judge if the process is effective? ISO 9001 Certification audits should surely be able to judge if the QMS can achieve this? The new standard should be able to ensure that this System Audit approach is no longer acceptable. However this will only occur if the training itself tightens up on the auditing activity or the System Audit approach to auditing may well continue to be used. Although there is recognition that this is not an effective way to carry out audits there is no real drive to improve the standard of auditing. It is this type of misunderstanding that undermines quality. Trying to market quality by revising a standard without improving what takes place will be ineffective Commonsense would indicate that there is more to quality than documented procedures. The biggest impact of ISO 9001:2015 will be on the Certification Bodies because the new standard has clearly stated that there are no mandatory procedures required. ISO 9001:2008 had six mandatory procedures as well as a need to have a quality manual. These requirements are no longer specified. This seems to be an attempt to put documented system requirements back into the hands of the organisation. The most significant change within ISO 9001:2015 is that leadership is responsible for deciding what is required within the organisations management system. It requires top management to demonstrate that they have accepted this responsibility and one way of doing this is to be involved from the start with the transition process within their organisation. This document demonstrates how this can be achieved. 5

6 2.0 STEP 2 ISO 9001:2015 clause 4 Context of an organisation It is suggested that you start with Clause 4 Context of an organisation after obtaining ISO 9000 and ISO 9001 known, in the UK as the BSI Essentials. Please read through the Introduction and Annex A of ISO 9001:2015 before you start making any changes. Clause 4 covers the context in which the organisation operates and how that could impact on their ability to meet the requirements of the standard. It includes external as well as internal issues as it relates to the scope of ISO 9001:2015. THE SPIRAL OF SCOPE (HOPE!) 2015 PDQMS It is up to the organisation and its leadership to take control of their management system. This is illustrated in the Spiral of Scope. This was developed from ISO/DIS 9001:2015 where Clause 4 indicates that all four sub clauses progress up to clause 5 Leadership. These four clauses state that "The organisation shall determine" or the organisation shall establish". So it is in the hands of the organisation to decide what is applicable. This is important because in clauses 4.1 a lot of the "Notes" cover issues that may not be applicable to the restrictive scope of ISO 9001 when judged against the product or service being provided. 6

7 11 QUALITY MANUALS AND HOW THEY MAY HELP As already mentioned in section 4 a quality manual is only about What an organisation does. It does not cover the Who, What, When, Where or How. The triangular pyramid approach to the documented structure shown in Section 4 explains this. This section is about the belief that a quality manual could help you get started towards complying with ISO 9001:2015. This section attempts to encourage organisations themselves to go through the Context Check List Attachment E and from the information identified revise the quality manual. A typical introduction from a quality manual is shown. It is very simple but it is believed that it is adequate to explain what can be done to control the transition to ISO 9001:2015. (KIS) It is perhaps appropriate to explain what a quality manual is. This top level document is intended to do nothing more than explain what an organisation is all about. It can be used for marketing as well as by Customers and other interested parties. The normal content of a Quality Manual (QM) is: - a) Introduction including the scope (This is what will be discussed in this section) b) The organisations policy (Does not have to be in the quality manual but often is) c) An organisation chart d) Any exclusions claimed against ISO 9001:2015 e) Descriptions of the key responsibilities and authorities. f) A commitment to complying with whatever standards are applicable e.g. ISO 9001:2015 g) Description, often in a flow chart format, of the sequence and interaction of the processes. h) A list of key procedures (Not all and without the revision and date listed) i) Amendment record This exercise will concentrate on the introduction section of a quality manual (QM). The QM may be used by interested parties such as the organisations Customers, Certification Bodies and any others who may need to have an overview of the context and activity of the organisation. As mentioned previously it is a very useful document for auditors to ask for as it gives them a good insight into what their products or services are and where they are located. The idea is to show the current example of a QM and then its revision to demonstrate how the example revision 2 can meet the requirements of the new ISO 9001:2015 standard. The Revision 2 has been made after going through the Context of the organisation Check List (Attachment E.) The introduction being used is a typical example for small businesses as there is little in the way of specific requirements stated in ISO 9001:2008 where Clause Quality manual only requires that: - The organisation shall establish and maintain a quality manual that includes: - 7