ISO 9001: What has changed from 2008 to 2015?

Posted on Posted in ISO 9001, Quality Management System

This post is aimed at those companies who have been certified against the 2008 revision of ISO 9001 but are now either considering or are in the process of transitioning to the new 2015 version. This transition must be made by September 2018. Use this article to familiarise yourself with the changes that you can expect to see in the new revision in comparison to its predecessor.

Structural Changes

The new revision sees some changes to the structure of the standard, the broad idea behind these changes is to provide more liberty in documenting the Quality Management System. First of all, the 2008 version included eight principles, whereas the 2015 revision contains seven. However, in terms of the principles the essence remains very much the same.

The 2008 version contained eight clauses whereas the new version has ten. New requirements here include Context of the organization (Clause 4) where the organization will need to determine the external and internal context that affects the organization. And also, Actions to address risks and opportunities (Clause 6.1)where when planning the QMS, the organization will need to determine the risks and opportunities affecting the organization. The idea behind these new requirements is to incorporate the QMS in everyday business activities.

And finally, instead of the six mandatory procedures required in the 2008 version, there are now six mandatory documents that do not have to be in the form of a procedure.

Similarities and differences

Different sections of the standard have see varying degrees of change in the newest revision. Some sections see very little change, and in this instance the QMS can remain the same. These include sections relating to Quality Policy, Leadership, Competence, Training and awareness, Management review, Internal audit and Corrective actions.

Other sections have experienced moderate changes. Sections that fall in to the category of moderate change include Control of externally provided processes, products and services; Quality objectives and plans for achieving them; Performance evaluation; Document management; Production and service provision; and QMS Scope. These sections require some attention and need to updated for you to become compliant with the new revision of the standard.

Finally you have the new requirements. These have to be established and incorporated into the existing QMS from scratch. New requirements include Risks and opportunities, Context of the organization, and Interested parties. You need to pay particular attention and care here as these change effectively change the approach and concept of the QMS and are critical for compliance.

What does ISO 9001:2015 mean for the QMS?

As mentioned the new revision introduces very significant changes in approach and in the concept of the QMS. A properly implemented QMS based on ISO 9001:2015 will lead to the following:

  • Better integration with other business activities
  • Enhancement of the process approach and PDCA cycle
  • Decentralisation of the system and spread of responsibilities for the QMS throughout the organisation
  • Greater involvement of the top management in the QMS
  • Introduction of risk-based thinking in the QMS
  • Higher emphasis on performance monitoring

We hope that this gives you a better idea of what to expect on your journey towards ISO 9001:2015. If you would like us to join you on that journey please visit our Quality Management System page and begin a free trial.