The changes to ISO9001:2015 and how they will effect you!
Significant changes to ISO 9001 will take place at the end of 2015. These changes will have a major impact for all users of this international standard, including implementing organisations, procurement organisations, training organisations, consultants, customers, certification bodies and auditors.
These changes will provide opportunities for Quality Management System development and improvement and will also provide the framework for quality assurance for the next decade, and maybe beyond.
With ISO 9001:2015 DIS (draft international standard) now published, organisations are in a position to see the differences between ISO 9001:2008 and ISO 9001:2015 (DIS). It is essential that management, quality professionals, supply chain personnel and auditors develop an understanding of the changes to their Quality Management System requirements, based on the upcoming changes to ISO 9001.
When will ISO9001:2015 take affect?
This will vary from organisation to organisation in terms of how much change will be needed. There will be a three-year transition period for certified organisations which will start when the standard is published. However, the standard writers and certification bodies are already encouraging organisations to make a start.
The first step is to gain an understanding of the new and enhanced requirements. Then do a Gap Analysis. Some will prefer to wait until the standard is formally issued before launching into redeveloping the quality management system, but we believe there is work that you can usefully get on with now.
The time required to implement 9001 and achieve certification varies according to a range of factors but 8–12 months is typical. That would take you pretty much up to the anticipated release date of the new standard. So, do you develop a QMS against the established requirements of ISO 9001:2008 or the potential requirements of ISO 9001:2015 as contained within the DIS?
Annex SL and other Management System Standards (MSS)
Annex SL (previously ISO Guide 83) defines the framework for a generic management system. All new ISO management system standards will adhere to this framework and all current MSS will migrate at their next revision. In future all ISO MSS should be consistent and compatible – they will all have the same look and feel. This could be the beginning of the end of the conflicts, duplication, confusion and misunderstanding from different MSS. It is a challenge to auditors to focus their own and their clients’ thinking on viewing organisations’ management systems holistically.
References to a documented quality manual, documented procedures and to quality records have been removed. Instead throughout ISO 9001:2015 DIS there are specific references to Documented Information. This is information which the organisation is required to keep, control and maintain. While ISO 9001:2008 specified a number of mandatory documents, DIS ISO 9001:2015 does not. However that does not mean that organisations have to throw away their quality manuals and documented procedures. If this documentation is in place and working well, there is no need to withdraw it.
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