ISO 9001 is undergoing a significant revision, complete with a new structure, new numbering scheme, new requirements, and the removal of some requirements. We’ve compiled a list of frequently asked questions about ISO 9001:2015 to help clear the confusion and get you off on the right foot as you prepare to transition to the new version of the standard.
Why is ISO 9001 being revised?
All ISO standards are reviewed every five years to establish whether a revision is required to keep them current and relevant for the marketplace.
Who is revising ISO 9001?
The body responsible for updating the standard is ISO technical committee 176 (ISO/TC 176). The committee began planning for the ISO 9001:2015 revision by hosting several open workshops with current users of ISO 9001. ISO/TC 176 also launched a web-based survey of users and potential users of the standard in 10 different languages and received nearly 12,000 responses from users in more than 120 countries.
In addition, ISO/TC 176 studied the latest concepts and trends in quality management that might be incorporated into future revisions. Finally, ISO/TC 176 worked with other ISO technical committees to develop a high-level structure, definition set, and common content that could be used across all management system standards. The result of this joint committee work has now been published as Annex SL to the ISO Directives.
Where are we at in the revision process?
ISO 9001:20015 is currently at the Final Draft International Standard (FDIS) stage, the fifth stage of a six-stage process, whereby the ISO subcommittee revising the standard will now go through all the comments received during the Draft International Standard (DIS) vote in order to produce a final draft which will then be put forward to all ISO members for voting.
The six stages of the ISO 9001:2015 revision process are:
- Working Draft
- Committee Draft 1
- Committee Draft 2
- Draft International Standard
- Final Draft International Standard
- International Standard
What is the next step?
Once all comments have been considered, a final draft will be produced and put forward to ISO members for voting. Once approved, ISO 9001:2015 will be published as an Internal Standard, probably in September or October of 2015.
Where can I buy a copy of ISO 9001:2015?
A copy of the ISO 9001:2015 DIS can be purchased now from several sources including ISO/ANSI/ASQ. Although ISO 9001:2015 has progressed to the FDIS stage, the DIS is the only version currently available. The FDIS should be available for purchase in May or June.
What are the goals of the revision process?
ISO/TC 176 has established a number of goals that it hopes to achieve with the ISO 9001:2015 revision. Goals include:
- Establishing a stable core set of requirements suitable for the next 10 years and beyond
- Ensuring that the ISO 9001:2015 standard remains relevant to organizations of all types and sizes in any industry sector
- Maintaining the standard’s current focus on effective process management as the primary tool to produce desired quality outcomes
- Accounting for changes in quality management systems practices and technology since the last major revision of the standard in 2000
- Reflecting on the requirements of the increasingly complex, demanding, and dynamic environments in which organizations operate
- Facilitating efficient and effective implementation of quality management systems, and streamlining the conformity assessment process
- Utilizing simplified language to aid in the understanding of ISO 9001:2015 and establish consistent interpretations of the standard’s requirements
- Applying the framework detailed in Annex SL to the standard to enhance compatibility and alignment with other ISO management systems standards
When will the final version of ISO 9001:2015 be published?
ISO 9001:2015 is due to be published by the end of 2015, probably in September or October.
What are some of the anticipated changes in the new version of ISO 9001?
ISO 9001:2015 is expected to include a number of important changes, including the following modifications:
- ISO 9001:2015 will adopt the high-level structure presented in Annex SL to the ISO Directives, as well as terms, definitions, and content similar to other management systems standards. It is anticipated that about 30 percent of the content of all future management systems standards will be identical.
- The standard’s current focus on process management will be strengthened, with a greater emphasis on producing desired outputs, and demonstrated confidence in an organization’s ability to consistently produce that output.
- The ISO 9001:2015 revision will employ more simplified language to ease the process of translating the standard into multiple languages, and to help ensure consistent application of its requirements.
- The revised standard will place an increased emphasis on risk management and business management throughout its scope.
- ISO 9001:2015 will include less explicit requirements for documented procedures, but more explicit requirements on documented information.
- The revision will modify the use of a number of terms, as follows:
- Use of the terms “products and services” instead of “product”
- An emphasis on “improvement” rather than “continual improvement,” reflecting common practice
- The terms “purchasing” and “outsourcing” will be replaced with “external provision of products and services.”
How soon can I start the transition process to ISO 9001:2015?
Although, your system must remain compliant with the requirements of ISO 9001:2008 until ISO 9001:2015 has been released, it may be useful to start communicating internally that a revision to ISO 9001 is on the way. You may also wish to look at your processes to see if they are in line with the new high-level structure. It’s recommended that you don’t make any changes to your management system until ISO 9001:2015 has been published and after your have consulted with your certification body (registrar).
How long will ISO 9001:2008 continue to be recognized and audited to?
The current standard will be recognized and can be audited to until the end of the three-year transition period for ISO 9001:2015 (expected September 2018). All organizations must transition to the new standard by the transition deadline at which point certificates for ISO 9001:2008 will no longer be valid.
Can I upgrade in 2016 during a recertification?
Yes—providing your system meets all of the requirements of ISO 9001:2015.
I’m currently implementing/considering certification to ISO 9001, what should I do?
Continue as planned—you still have a full three years to transition to the new standard once it’s published in September 2015. It’s a good idea to become familiar with the new high-level structure as you are building your system so you can easily upgrade to the new standard at your next recertification.
What is Annex SL?
Annex SL is a high-level structure created by ISO in order to provide a universal high-level structure, identical core text, and common terms and definitions for all management system standards. It was designed to make it easier for organizations that have to comply with more than one management system standard.
The core text on Annex SL has ten high-level clauses, these are:
- Normative references
- Terms and definitions (subdivided into three parts): high-level structure, identical core text, and common terms and core definitions
- Context of the organization
- Performance evaluation
Annex SL has a total of 45 “shall” statements resulting in 84 requirements. By the way, the “SL” in Annex SL doesn’t mean anything. It is just part of ISO’s numbering scheme.
How do I know how all of these changes affect my organization’s registration?
Check with your certification body/registrar. Certification bodies are well aware of the coming changes, deadlines, and industry-specific requirements in sector-specific standards. They are also well aware of your organization’s registration status and particular needs. Let them be your partner in the transition process.
We will update these questions as ISO 9001:2015 progresses and questions are posted to our comments section. Please comment. We’ll try to answer (or find the answer) to all the questions.