The ISO 9001:2015 Revision

The ISO 9001 Standard Revision

ISO 9001 is the most widely applied quality management system standard in the world. It covers every part of the production cycle, from R&D and input materials through to the final product. ISO 9001, the most widely adopted management system standard in the world, went through a revision in 2015.

The ISO 9001:2015 revision takes the standard into line with recent sector developments and aligns it with other management system standards such as ISO 14001. Work on the revision started in 2012. The draft international standard was published in 2014, and the finished standard was expected for release in September 2015. To support alignment across management system standards, the revised ISO 9001 is built on the High Level Structure, with management made simpler to apply. The changes from ISO 9001:2008 to ISO 9001:2015 include the following.

1. Competence

An organisation that operates a quality management system has to identify the people whose work affects quality performance and, in the process, make sure those people are kept competent to carry out that work. Competence is defined as the ability to apply knowledge and skills to reach the desired results.

2. Documented Information

3. Externally Provided Products and Services

4. Exclusions

The revised standard no longer asks the organisation to describe which quality management system requirements cannot be applied because of the nature of its work. The different approach in the new edition of ISO 9001 removes this, so meeting every requirement of the standard to cover the organisation's quality management system is no longer a mandatory item under the 2015 edition.

5. Products and Services

References to the word "product" (as used in ISO 9001:2008) are replaced with the phrase "products and services".

6. Improvement

The phrase "continuous improvement" is replaced by the single word "improvement".

7. Interested Parties

An organisation that wants to put its quality management system in place has to identify who its "interested parties" are.

An interested party (defined as a "stakeholder") is any person or organisation that affects, is affected by, or perceives itself to be affected by an activity or a decision of the organisation's quality management system.

8. Preventive Action

There is no longer a specific requirement for "preventive action". The core reason is that prevention is already built into the quality management system as one of its primary purposes.

9. Process Approach

Organisations now need to apply a process approach to their quality management system, and the standard provides a list of the required elements of that approach.

10. Risks and Opportunities

When planning their quality management system, organisations need to identify the risks and opportunities that may affect the system's ability to reach its intended outputs. The organisation then plans actions to address these risks and opportunities, applies them in the quality management system processes, and reviews the effectiveness of those actions.

Note: ISO 9001:2008 certificates lapsed in October 2018. Certificate holders still on ISO 9001:2008 should transition to ISO 9001:2015 at the earliest opportunity. Sistem Patent Kalite, the certification and testing consultancy, supports the transition from start to finish.