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Home | Resources | INform | Archiv e | Technical | ISO 9001:2015 the countdown begins

ISO 9001:2015 APG papers Technical notes Online com m unities INform Archive

ISO 9001:2015 the countdown begins


Peter Lomas, IRCAs Executive Director, presents IRCAs standpoint on the ISO 9001 standard revision and gives his advice on how auditors should prepare in advance of the changes.

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The Committee Draft (CD) version of ISO 9001 (ISO CD 9001) was released for comment and ballot at the beginning of June. The Chartered Quality Institute (CQI), of which IRCA is a division, has Category A liaison status with ISO/TC 176, the technical committee responsible for ISO 9001. This means that the CQI has access to all relevant documentation, is invited to meetings and has nominated its own experts to participate in the work of TC 176 and influence the revision of ISO 9001. The CQI is now actively facilitating consultation and will comment on behalf of CQI members. The closing date for submission of comments and votes is 10 September 2013. IRCA, as the professional body for management system auditors and a division of the CQI, is exceptionally well placed to keep IRCA auditors informed throughout the development process. At this moment we expect the timetable for publication to be: Draft International Standard (ISO DIS 9001) April to August 2014 Final Draft International Standard (ISO FDIS 9001) July to August 2015 Publication ISO 9001 September 2015. So there is a long way to go before the fifth edition of ISO 9001 is published.

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What do we know and expect?


ISO gave approval in 2012 to start a major revision of ISO 9001, which would be suitable for the next 10 years or more. ISO 9001 will adopt the high level structure, identical core text and common terms and core definitions of Annex SL (approximately 30% of each new and revised standard will be identical text). The current focus of ISO 9001:2008 on effective process management will be maintained, with greater emphasis on producing desired outputs and providing confidence in the organisations products. Simplified language and writing styles to aid understanding and consistent interpretations of requirements has been set as a requirement for the finished standard. Use of terms goods and services rather than product, and improvement rather than continual improvement is proposed. Purchasing and outsourcing are replaced by external provision of goods and services. The CD version makes explicit references to risk, identifying risks and opportunities and planning actions to address risks and opportunities identified. These replace preventive action in the current standard. The CD also identifies and addresses risks which can affect conformity of goods and services and customer satisfaction, including taking a risk-based approach to determine the type and extent of controls appropriate to each external provider and all external provision of goods and services. There is now a greater business focus. External as well as internal issues related to the organisations strategic purpose, interested parties and their requirements must all be determined. Quality policies and objectives must be compatible with the strategic direction of the organisation. Subsequently, the organisation must consider these in determining the scope of the QMS. Senior management now has a greater active involvement. There are less explicit requirements for documentation, no reference to documented quality manual and documented procedures, and no reference to quality records. Instead, the CD version refers to documented information, ie information required to be controlled and maintained by an organisation and the medium on which it is contained. Expect more detailed reviews and analysis by IRCA as the standard progresses towards the final version.

IRCA opinion

To say that we can expect a lot of debate, speculation and comment is an understatement. We anticipate the debate to continue long after publication in 2015. The direction being taken was apparent when Annex SL was published and is even clearer now we have ISO/CD 9001. Some will not like it and may seek to block publication or choose to develop industry standards independent of ISO 9001. A second Committee Draft would indicate slow progress. The aim of ISO 9001 is to assist organisations in improving the quality component of their business management system, in the same way that ISO 14001 aims to assist organisations in improving the environmental component of their business management system. Annex SL helps us to think in terms of organisations having a single business management system, built on the organisational core activities and processes which are covered by the common text of Annex SL. With the adoption of Annex SL, the potential for radical change is significant think in terms of a single business management system audit and certification, and in terms of audits following the principle of a generic audit of the organisational core, prior to bringing in experts to audit the organisational specialisms and component parts of the business management system. Id also envisage an increase in remote auditing as it will be too expensive to amass the required team in one location. These concepts are for the future, beyond 2015, but are made possible by Annex SL. ISO management system requirements are not written for the express purpose of audit and certification. However, an important part of the development process is to ensure we end up with an auditable standard. At the IRCA Forum on 23 June there was discussion around auditability of ISO 9001:2015. The requirements need to be capable of being audited, which is the responsibility of standard developers. Auditors also need to be capable of auditing the requirements, which is the responsibility of organisations employing auditors. The discussion, led by experienced and well informed people, proposes that a significant number of organisations and auditors never quite understood the process approach, and that some requirements of ISO 9001:2000 and ISO 9001:2008 have been totally disregarded by a large percentage of organisations and certifiers for the last 13 years. If so, there is an urgent need to start addressing this now, before the next version of ISO 9001 is released.

What should IRCA auditors do now?


Many of the significant changes that will be in ISO 9001:2015 originate from Annex SL. All IRCA auditors must familiarise themselves with this document. If you have not already read IRCAs guide to Annex SL , do so now. You will find it under Technical Notes on our website. If you have read it, have another look. ISO 9001 will not be the first standard to adopt Annex SL. ISO 22301:2012 Business Continuity management systems requirements adopted ISO Guide 83 an early version of Annex SL and there are IRCA briefing notes on ISO 22301:2012 available on the IRCA website. The next issue of ISO 27001 Information Security management system requirements is due to be published in November 2013. And the next issue of ISO 14001 Environmental management system requirements is due to be published in March 2015. So, by the time ISO 9001:2015 is published, there should already be a degree of experience of implementing and auditing many of the new and enhanced requirements originating from Annex SL. To keep you informed and to support your continuing professional development, IRCA will be publishing briefing notes and technical guidance on all of these standards at each stage in their development. All information will be available on our ISO 9001:2015 section of the website. Return to IRCA INform Issue 41 front cover

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