The most popular standard of the 27,000 standards produced by the International Organization for Standardization (often referred to as “ISO”) is ISO 9001 the standard for quality management systems – and it’s going through changes right now. Each and almost every international standard goes through a process of review, typically every five years, to ensure it’s up to date and still meeting user needs. The last time ISO 9001 went through the process was in 2015 and, at that time, it was thought that any revision should be sufficiently robust for the following 20 years. The five-year review was still held in 2020, and the decision was made not to revise. Which leads us to 2025. Details of the revision process can be found here.

Today, we’re in the final stages of gathering and processing feedback from the marketplace, in response to the initial draft of the revisions to ISO 9001 – what is known as the “DIS” – draft international standard. A lot of input and collaboration has been going on in the background between the various international members of the committee responsible – ISO TC 176. That work has culminated in a draft which looks surprisingly similar to the 2015 version of ISO 9001 and is available for review and comment through the standards body of each participating member country.

What has been released for public comment includes the following (presented in overview):

Sections 1 to 3

Mainly (minimal) editorial changes and additions in normative references as well as definitions to align with referenced standards.

Section 4 Context of the Organization

The amendment from 2024 regarding consideration of climate change is incorporated (it’s not specific to only ISO 9001, being part of the Annex SL format) and some rewording - which hasn’t affected the meaning of the basic requirements.

Section 5 Leadership

A fairly significant addition has been made by the inclusion of the requirement for leadership to demonstrate “promoting quality culture” and “ethical behavior.” A new note is added to provide guidance on these aspects.

Other parts of this section have had minor edits not really affecting the meaning of the requirements.

Section 6 Planning

For greater clarification of the terms “risks and opportunities” each has been given its own sub-section:

• Actions to address risks
• Actions to address opportunities

Along with some textual edits, including guidance notes relating to the above, sub-section 6.3 has additional requirements relating to changes which are planned, including:

• Monitoring and evaluation of effectiveness of the changes
• Communication of the changes
• Reviewing results of changes

Section 7 Resources

The majority of this section remains intact with some rewording and a small quantity of clarifications, particularly in relation to infrastructure, calibration and organizational knowledge.

In subsection 7.3 Awareness, the complimentary requirements (to that in section 5) regarding “organizational quality culture” and “ethical behaviour” have been added.

Section 8 Operations

Section 8 is the focus of the quality management system requirement when considering the quality of products and services.

Section 8.2.1 adds the need for Customer communication to include:

“e) information related to contingency actions, including where relevant to any disruptions…”

Some new notes are added to the Product design and development section, 8.4 and recognize “non-linear” development design cycles. There are some minor text additions to the various sub-sections, including the requirement to make documented information available, instead of it being retained.

The revision affecting section (8.4) Control of externally provided products and services (popularly known as “Purchasing”). It adds text (to 8.4.3) regarding communications:

“d) the external providers’ interactions with the organization and, where applicable, its customers and other relevant interested parties;”

The requirement to control the Production and service provision (8.5) now includes text regarding the availability and use of documented information and validation and periodic revalidation of what are commonly known as “special processes” – those which cannot be verified after processing.

Section 9 Performance evaluation

Section 9 has undergone some subtle rewording in that performance is now to be evaluated as well as analyzed (9.1.1).

The internal audit section (9.2) has a new heading added, (9.2.2) Internal audit program and in that section is now added the requirement for audit objectives.

The requirements for Management review (9.3) of the quality management system has been reworded to add, as inputs (9.3.2) changes to the internal and external issues that are relevant to the quality management system.

Section 10 Improvement

The final section of the DIS9001 document changes improvement to continual improvement.

There’s some rewording which removes “complaints” to a note, some merging of sub-clauses 10.1 and 10.3.

Annex A

This section augments the various notes found throughout the sections of the international standard and provides further clarification. For example, Annex A.7.1.5 introduces the calibration hierarchy and CRMs (Certified Reference Materials). This specific note provides clarity to the science of calibration – a term often misunderstood and misapplied.

The Annex has been extensively edited with texts which address what appear to be common misconceptions regarding effective and efficient implementation of quality management systems. They do, however, not modify in any way the requirements found in section 4 through 10. A note states as much.

Annex B

Has been deleted.

Next Steps

The International Organization for Standardization’s process for the development of management standards, such as ISO 9001 will now move the collected feedback on the DIS version and move through the committees to the next version, the “FDIS” – the final draft international standard. At the time the FDIS has been drawn up, it too will be available for public comment and is usually anticipated to be close to the final published standard.

Currently, there is much misinformation which can be found regarding the content and direction of the DIS9001 document. Furthermore, there’s the (artificial) anticipation of organizations to begin their preparations for the new version. Nothing could be further from the truth. Certified organizations will be allowed to review and update their quality management systems, as have been done over the past 35 years and four versions. The transition period can be as much as three years (a full certification cycle) but nothing has been formally announced at this point.

For more information on the development of ISO 9001, watch here for the latest, from those involved in the process.