22 March 2017
Per rules stipulated by the International Organization for Standardization, the ISO 9001 standard is reviewed and revised every 6-8 years.
The ISO 9001 standard was first revised in 1994 and then underwent a major revision in 2000. In November 2008, ISO published ISO 9001:2008, which included only minor changes. Almost seven years later, in September 2015, the latest revision was published. This new revision is about to supersede the former standard, though ISO 9001:2008 will remain applicable until it's phased out in the third quarter of 2018.
The following is a summary of the changes in ISO 9001:2015 compared to its predecessor (ISO 9001:2008).
The International Organization for Standardization (ISO) is currently aligning all of their management systems standards in order to improve consistency and in order to simplify the implementation of more than one management systems standard (for example, ISO 9001 certified companies will find it much easier to set up ISO 14001). ISO 9001:2015 is based on Annex SL, the new high-level framework for all management systems standards, which will bring a common structure and common language to all standards. Therefore, there are several changes in ISO 9001:2015 which will make it easier for companies to integrate ISO 9001 with their existing business processes.
The most important changes in the new ISO 9001:2015 standard are:
More emphasis on leadership
ISO 9001's coverage now further extends to senior management's understanding of its business environment (including social, cultural and regulatory) and its internal strengths and weaknesses. This results in the quality management system getting more integrated into operational processes and that the policy and objectives are compatible with the strategy of the company, and top management more involved in ISO 9001.
New focus on risk management
The 2015 version of the standard introduces a new clause on risk management (clause 6.1 "Actions to address risks and opportunities") which builds upon the ISO 9001:2008 section on preventive action.
Clarifications on objectives, measurement and change
The requirements regarding quality objectives are more detailed. However, this is mainly clarification of requirements in the 2008 version rather than new requirements.
More emphasis on communication and awareness
The two new clauses 7.3 "Awareness" and 7.4 "Communication" place further emphasis on these two areas.
Fewer prescriptive requirements
The 2015 version has less prescriptive requirements, including less requirements on documentation. For example, there aren't explicit requirements for "quality procedures" and a "quality manual" anymore. However, the standard contains numerous implicit documentation requirements which, for all practical matters, mean that procedures covering most or all ISO 9001:2015 requirements must be established. Further, a so-called "Management Representative" is no longer required; instead, the same responsibilities simply last with top management. Most companies, therefore, maintain the role of Management Representative.
The structure of the standard underwent some changes to reflect the above described changes. The new standard is structured as follows:
Clause 3: Terms and definitions
Depending on your needs, you may be wondering how the new ISO 9001:2015 revision affects you and how you should proceed. Here are some considerations:
If your company currently holds ISO 9001:2008 accreditation:
You should start the transition to ISO 9001:2015 now.
ISO 9001:2008 certificates remain valid for up to three years from publication of ISO 9001:2015 (until September 2018). We recommend that you start the transition to ISO 9001:2015 without delay to avoid any last-minute rush. By now, there are many ISO 9001:2015 upgrade tools available that will make your transition rather easy and fast.
If your company is currently in the process of implementing ISO 9001:2008:
If you are in the midst of implementing ISO 9001:2008, you best switch over to ISO 9001:2015 now. You will find that you will be able to utilize much of your work.
If you are almost done with the ISO 9001:2008 implementation, may complete it and then use ISO 9001:2015 upgrade tools right away to update your system to the new standard. This way you only need to make some modifications and additions to your ISO 9001:2008 quality management system.
If you are still at the beginning of ISO 9001:2008 implementation, you best start over and set up ISO 9001:2015. Don't worry, much of your work can still be utilized.
If you are planning on getting ISO 9001 certification:
Implement ISO 9001:2015 now.
Try to get your ISO 9001 certification as soon as possible. The sooner your company is ISO 9001 certified, the sooner your company will benefit. Don't waste time.
If you are planning on using templates for your ISO 9001 documentation, see our section on ISO 9001 documentation templates) for useful tips.
We expect the next revision to be published in 2022 or 2023.
We will update our website as soon as the technical committee responsible for ISO 9001 revisions publishes its first draft. This will likely be about one year prior to formal publication of the revised standard.