According to the rules of the International Organization for Standardization (ISO - the publisher of the ISO standards), the ISO 9001 standard undergoes review and revision every 6-8 years.
In the past, 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.
On September 23, 2015, the latest revision of ISO 9001 was published; it is called ISO 9001:2015. This new revision will supersede ISO 9001:2008; however, on September 23 started also a 3-year transition period during which ISO 9001:2008 remains fully applicable and ISO 9001:2008 certifications remain valid.
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 top management' 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 builts 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". If this will have any practical effect on ISO 9001 documentation will have to be seen as interpretations get established. Also, the role of "Management Representative" is no longer required; instead, the same responsibilities simply last with top management. Again, if this will have any practical effect will have to be seen over the next several months.
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 where you are in the ISO 9001 process, you will be wondering how the new ISO 9001:2015 revision affects you and how you should proceed. Here are some considerations:
If your company currently has ISO 9001:2008 accreditation:
You don't need to do anything right now. You will have 3 years time to adopt ISO 9001:2015 until September 2018.
ISO 9001:2008 certificates remained valid for up to three years from publication of ISO 9001:2015 (until September 2018). We recommend that you take your time to update your quality management system as more and more resources will become available once the 2015 version has been published. For example, if you used templates for your current quality management system, your template provider may offer guidance and templates to make the transition easy. Also, new training courses will become available after the 2015 revision has been published. Last but not least, we will only know how auditors interpret the new requirements after the 2015 version has been in place for a while. We, therefore, suggest that you plan to transition to ISO 9001:2015 towards the end of the 3-year transition period.
If your company is currently in the process of implementing ISO 9001:2008:
Continue your ISO 9001 implementation based on ISO 9001:2008. The sooner you have an ISO quality management system in place, the sooner you will reap its benefits, no matter if it is the 2008 version or the 2015 version. Don't waste time.
Right now, there are countless resources and tools available that help you implement ISO 9001:2008. On the other hand, it will take some time until a similarly wide selection will be available for the 2015 version. Also registrars and auditors will require some time to transition to the new ISO 9001:2015, and then it will take time until common interpretations have been established also among auditors. Within the next two years, uncertainties will get reduced and prices will go down with an increase in supply of ISO 9001:2015 tools, resources and auditors.
Transitioning from the 2008 version to the 2015 version of the standard will be much easier than starting from scratch. Plan on doing the transition towards the end of the 3-year transition period (about late 2017).
If you are planning on getting ISO 9001 certification:
Implement ISO 9001:2008 now and then transition to ISO 9001:2015 towards the end of the 3-year transition timeframe (about late 2017).
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, no matter if it is the 2008 version or the 2015 version. Don't waste time.
It is rather easy and inexpensive to implement ISO 9001 right now given the many resources, training materials and tools available. On the other hand, it will take some time until a similarly wide selection will be available for the 2015 version, until a common ground is established in terms of interpretations and auditor requirements.
We expect the next revision after ISO 9001:2015 to be published in 2022 or 2023.