ISO 9001:2015 Revision • The World’s Number One Standard – ISO 9001, is changing… again, in 2015 • The changes will be significant – this is a major overhaul and will impact ourselves and our clients • We need to understand the details of the changes and the change process • We need to manage the change process for ourselves and for our clients
ISO 9001:2015 Revision What are we going to talk about today? • Background to the change • The change process and timeline • The importance of Annex SL • Outline of the Implementation and transition process • The new requirements – by Margaret Rooney
ISO 9001:2015 Revision Background to the change • ISO 9001 is the world’s most used standard – there are well over 1,000,000 registered users worldwide • All Standards are subject to an ongoing review process – approximately every 5 years • Last change was 2008 – so this change is running late • Last change was (relatively) minor in detail – this will be a major overhaul (like 2000) • Philosophy on Quality Management changes with time, eg challenges with globalisation, electronic systems, etc. • ISO 9001 needs to keep up with the world
ISO 9001:2015 Revision The change process: • The revision process is managed by ISO’s Technical Committee, ISO/TC 176 • Comprises of international delegates representing the interests of users of ISO 9001 • Feedback to the committee on proposed changes is possible, eg via CQI and each potential change is examined and put to vote • We must have faith in this process and be positive that the end result will be a better standard for us to work with • We need to sell this change to our clients positively • We need to manage our clients’ expectations and sell the value of the changes to them – we need our clients today to be clients in the future • This is vital to our business
ISO 9001:2015 Revision • Timeline Source – iso.org
ISO 9001:2015 Revision • Timeline: • June 2012 – Working Document (WDO) and design specification published • December 2012 – Working Draft (WD) Published • April 2013 – Committee Draft (CD) Published • April 2014 – Draft International Standard (DIS) Published • January 2015 – Final Draft International Standard (FDIS) Published • Proposed Final Publication Date - September 2015 • The Committee is very keen that the final publication date does not slip…
ISO 9001:2015 Revision • Annex SL: • A Standard for Standards • High Level Structure; Identical Core Text; Common Terms and Definitions • Common format for the development of all management system standards. • Will allow users to more easily integrate new functional standards into their existing management systems • 10 clauses • The clauses have been agreed at ISO level and cannot be changed by the development committee for ISO 9001 • 50% of the changes to ISO 9001:2008 are Annex SL based • We need to get familiar with this structure:
ISO 9001:2015 Revision Annex SL High Level Structure: • 1. Scope • 2. Normative References • 3. Terms and Definitions • 4. Context of the Organisation • 5. Leadership • 6. Planning • 7. Support • 8. Operation • 9. Performance Evaluation • 10 Improvement
ISO 9001:2015 Revision • Into this high level structure have been slotted the requirements – including some new ones… • It is thought that there will be no exclusions clause in ISO 9001:2015 – The ‘Context of the Organisation’ clause now being used to determine system planning requirements. • There is an excellent briefing note that has been prepared by IRCA containing all the detail of Annex SL – it is available to download for free from the IRCA Website - read it!
ISO 9001:2015 Revision • Implementation and transition process • Start talking to clients now – as from tomorrow! Not too much detail, but begin preparing them for change... • We will hold more training/briefing sessions as the further detail becomes clear. • Following publication there will be a three year transition period (as there was in 2000). • During transition, certificates to the 2008 and 2015 versions will have equal validity. • NQA will prepare a gap analysis checklist • At a Client’s first visit following reissue we will undertake a gap analysis and leave a report.
ISO 9001:2015 Revision • At the next visit we will evaluate the work the client has done, either accept it and issue updated certification, or raise findings for further action. • At the third visit (as the transition period ends) any outstanding actions would become nonconformities. • It is up to us to sell the value of the changes to our clients and keep them engaged with the process – so that they keep registration • This is our challenge!
ISO 9001:2015 Revision • The new requirements • Hand over to Margaret Rooney • Thanks for listening…
ISO 9001:2015 Revision Important note: • The current DIS is for information only for members of WG 24 • The DIS ballot will run from 10 July 2014 to 10 October 2014 • In practice, comment will need to be with BSI/CQI/ABCB, well before 10 October – watch deadlines closely
ISO 9001:2015 Revision Important note: • The ISO management system standards are the basic tool of our trade • We should, individually and corporately, be proactive in helping to shape their future • Make comment through NQA, CQI and BSI
ISO 9001:2015 Revision In this presentation: • High level structure text and references will be in blue • Discipline specific, (ie quality) text and references will be in black
ISO 9001:2015 Revision • We shall take a quick look at the more significant changes and nuances of the clauses in the new structure. • Take time to carefully read the standard yourselves – we shall each probably note different things and assign varying degrees of significance to the DIS proposals
ISO 9001:2015 Revision Introduction • 0.3 Process Approach • Promotes the adoption of a process approach • Makes reference to the PDCA methodology • Overall focus on “Risk-based thinking”
ISO 9001:2015 Revision 0.5 “Risk-based thinking” • Concept always implicit in ISO9001 • Now made explicit • Formal, extensive approaches to risk assessment do not have to be deployed • Risk is related to the consequence of non- conformities • Degree of risk will influence the rigour and degree of formality required of the QMS
ISO 9001:2015 Revision 3 Terms and definitions • There are 69 terms with associated definitions in the DIS • 21 of the terms relate to the high level structure • 48 terms are discipline, (quality), specific
ISO 9001:2015 Revision 3 Terms and definitions Example high level terms: • 3.01 Organisation • 3.03 Requirement • 3.04 Management system • 3.05 Top management • 3.09 Risk • 3.12 Process • 3.17 Audit
ISO 9001:2015 Revision 3 Terms and definitions Example discipline (quality) specific terms: • 3.22 Correction • 3.24 Context of the organisation/business environment • 3.26 Customer • 3.27 Supplier/provider • 3.37 Quality • 3.44 Design and development • 3.69 Measuring equipment
ISO 9001:2015 Revision 4 Context of the organisation • Purpose • Strategic direction • Interested parties • Scope • Processes
ISO 9001:2015 Revision 4.4 Quality management system and its processes Much of this is familiar to us, but there are some new emphases: “…the organisation shall determine: a) the inputs required and the outputs expected from these processes; e) the assignment of the responsibilities and authorities for these processes; f) the risks and opportunities in accordance with the requirements of 6.1, and plan and implement the appropriate actions to address them;
ISO 9001:2015 Revision 5 Leadership There is much emphasis on “top management”, eg • Demonstrate leadership and commitment • Ensure policy and objectives are compatible with the strategic direction and context of the organisation • Ensure the integration of the QMS into the business processes • Promote awareness of the process approach
ISO 9001:2015 Revision 6 Planning for the quality management system 6.1 Actions to address risks and opportunities • When planning the QMS, take account of: • The context • Needs and expectations of interested parties • Potential impact on conformity
ISO 9001:2015 Revision 7 Support • This section has a mixture of high level and discipline specific requirements.
ISO 9001:2015 Revision 7 Support – discipline specific elements • People • Infrastructure • Environment for the operation of processes • Monitoring and measuring resources – includes calibration • Organisational knowledge
ISO 9001:2015 Revision 7 Support – high level elements • Competence • Awareness • Communication • Documented information
ISO 9001:2015 Revision 8 Operation • Looks and feels much as we are used to • A significant section of the DIS, and one that has undergone most discipline significant changes since the committee draft of 2013.
ISO 9001:2015 Revision 8 Operation Between the CD and the DIS, the following revisions have been incorporated: Market needs and interactions with customers reverts to Determination of requirements for products and services
ISO 9001:2015 Revision 8 Operation Between the CD and the DIS, the following revisions have been incorporated: Goods and services reverts to Products and services “Design” is back in
ISO 9001:2015 Revision 8 Operation • Design and Development have been very much enhanced • The process approach is more explicitly spelt out here than elsewhere in the DIS
ISO 9001:2015 Revision 9 Performance evaluation • 9.1.2 Customer satisfaction • 9.1.3 Analysis and evaluation
ISO 9001:2015 Revision 9 Performance evaluation • 9.2 Internal audit • 9.3 Management review ……including some discipline specific requirements within the above
ISO 9001:2015 Revision 10 Improvement • General • Nonconformity and corrective action • Continual improvement An overall emphasis on analysing and removing the causes of nonconformity
ISO 9001:2015 Revision Future challenges – Margaret’s view We need to be competent in the following areas to properly audit and add value: • Process Approach • Risk based thinking • Leadership • Strategic direction • Context • Organisational knowledge
ISO 9001:2015 Revision Future challenges – Workshop Working within your groups, consider what assessors may need to do to ensure competence in the following areas: • Process Approach – Team 1 • Risk based thinking – Team 2 • Leadership and Strategy – Team 3 • Context and Organisational knowledge – Team 4