22 March 2017
The International Organization for Standardization (ISO) reviews and revises the ISO 9001 standard every 6-8 years. It was first revised in 1994 and underwent a major revision in 2000. In 2008 another revision was published, though it included only minor changes. The latest revision, ISO 9001:2015, was published in September 2015.
The new revision improves on the former standard in several ways. Vocabulary and structure have changed as part of ISO's new "Annex SL" initiative aligning its management systems standards in order to improve consistency and simplify the implementation of more than one standard. In practical terms this means ISO 9001-certified companies (or companies seeking to implement ISO 9001) will now find it much easier to set up the environmental management standard, ISO 14001. In terms of content, ISO 9001:2015 introduces several new and modified requirements, which place more focus on results and which make it easier for companies to integrate and align with their existing business processes.
The following video is presented by Kevin McKinley, ISO's Acting Secretary General, and answers numerous frequently asked questions about ISO 9001:2015 and how it improves on its predecessor. As the video shows, the new revision was a big undertaking – it involved input from 153 experts from 81 participating countries
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 becoming more integrated into operational processes, quality policy and objectives fully aligned with corporate strategy, 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. The combination of risk-based thinking and process approach refocus the standard on performance and results, and the Plan Do Check Act cycle is employed at all strata in the organization.
Clarifications on objectives, measurement and change
The requirements regarding quality objectives, measurement and change are more detailed. However, this mainly involves clarifications 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 new standard is less prescriptive than its predecessor and focuses more on performance and results. There are fewer explicit documentation requirements than in all previous versions, and even "quality procedures" and a "quality manual" aren't even mentioned. However, the standard contains numerous implicit documentation requirements which, for all practical matters, mean that procedures covering most or all ISO 9001:2015 requirements should be established. Further, a so-called "Management Representative" is no longer required (though in practice most companies will continue to assign a member of staff to fulfill this role).
New high level structure
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. The advantage: it's now easier to integrate ISO 9001 with ISO 14001 and other ISO standards.
The new structure is as follows:
Clause 0: Introduction
Clause 1: Scope
Clause 2: Normative references
Clause 3: Terms and definitions
Clause 4: Context of the organization
Clause 5: Leadership
Clause 6: Planning
Clause 7: Support
Clause 8: Operation
Clause 9: Performance evaluation
Clause 10: Improvement
There are several key reasons why ISO 9001:2015 is better than its predecessor, some of which are highlighted in the infographic below. Possibly the most important improvements are the standard's new structure and focus on risk-based thinking.
The most obvious change to the standard is its new structure – ISO 9001:2015 now uses the same overall structure as other ISO management system standards (which ISO refers to as the "High-Level Structure" as defined in Annex SL), making it easier for enterprises using multiple ISO management systems. Another significant improvement is the focus on risk-based thinking. While the preventive action requirements of ISO 9001:2008 partially addressed risk-based thinking, the new revision lends increased emphasis to this concept.
You may be wondering how the 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 until September 2018. We recommend that you start the transition to ISO 9001:2015 without delay to avoid any last-minute rush. There are many tools available to make the transition easy and fast.
If your company is currently in the process of implementing ISO 9001:2008:
If you are at the beginning or in the midst of implementing ISO 9001:2008, switch over to ISO 9001:2015 now. Most of your work can be retained and re-used. This approach – which all ISO 9001 professionals recommend – means you won't have to spend additional time transitioning to ISO 9001:2015 at a later date.
If you are almost done with a ISO 9001:2008 implementation, complete it and then use ISO 9001:2015 upgrade tools to update your system to the new standard. The modifications and additions needed to upgrade your Quality Management System will in most cases be straightforward and quite easy to implement.
If you are planning on getting ISO 9001 certification:
Implement ISO 9001:2015 now and try to get your certification as soon as possible. The sooner your company is certified, the sooner your company will reap the benefits. Refer to our article about the benefits of ISO 9001 to learn more.
If you plan to implement ISO 9001 in-house with the help of template kits (also known as certification packages), see our section on ISO 9001 documentation templates for information and advice.
The world has changed, and the 9001:2015 revision is needed to reflect some of these changes
Kevin McKinley, Acting ISO Secretary General
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.