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.
Business has changed radically since the last major revision in 2000; technology has changed how we work, geographical boundaries are almost insignificant in today’s global economy, supply chains are increasingly complex and the information available has multiplied exponentially.
To ensure that ISO 9001 continues to serve the business community and maintain its relevance in today’s market place, the standard is being revised to address the change in the business world.
With ISO 9001:2015 DIS (draft international standard) now published and the ISO9001:2015 FDIS due any day, 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.
One thing remains constant, to be successful, businesses have to adapt to meet the growing needs of customers. ISO was originally written with the customer in mind and that remains the priority for ISO 9001:2015.
The New ISO 9001 Structure
The new standard expected in September 2015, will be based on Annex SL – the new high level structure (HLS) that brings a common framework to all management system standards. This helps to keep consistency, alignment different management system standards, offer matching sub-clauses against the top-level structure and apply common language across all standards.
The key changes in the proposed standard are:
- The emphasis on leadership
- The focus on risk management
- Emphasis on objectives measurement and change
- Communication and awareness
- Fewer prescriptive requirements
With the new standard in place, organizations will find it easier to incorporate their quality management system into the core business processes and gain greater business benefit.
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.
Whilst 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.
When Will ISO 9001:2015 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.