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The Right Approach: Get Ready for ISO 9001 Version 6

We are well past the normal five to seven years that a new revision of the ISO 9001 international quality standard gets released. It may be finished toward the end of 2025, with implementation starting in 2026, and there will be as many significant changes as we saw in the current 2015 version. 

A History of ISO Revisions
The International Organization for Standardization (ISO) revises the ISO 9001 standard every five to seven years. The first revision came in 1994, followed by a major overhaul in 2000. Another revision occurred in 2008, but with only minor changes. The latest update, ISO 9001: 2015, was released in September 2015 and came with the most dramatic changes. Here is a quick history of the ISO revisions:

ISO 9001: 1987: The initial edition of the ISO 9001 standard was derived from a military quality standard and focused on manufacturing. There were originally three quality standards in the ISO family:

• ISO 9001: Design, new product development, production, and installation
• ISO 9002: Everything in ISO 9001 except new product development
• ISO 9003: Final inspection and test

ISO 9001: 1994: This first revision added the concept of preventive action rather than just checking conformance of the final product.

ISO 9001: 2000: This second revision combined ISO 9001, ISO 9002 and ISO 9003 into a single, universally applicable standard that allowed for exclusions of requirements that don’t apply to the organization.

ISO 9001: 2008: The 2008 revision introduced some new wording and clarifications, but no new requirements.

ISO 9001: 2015: The latest revision of the standard introduced the new high-level structure (Annex SL) and featured several new and modified requirements, most notably the concept of risk-based thinking.

• ISO published ISO 9001: 2015/AMD1: 2024 in February 2024, which amends Section 4 to include climate action considerations. (Anyone who knows me well understands how I feel about this amendment!)

The 2015 revision finally got it right with Annex SL, which provided a standard with requirements in an order that actually made sense, and followed the Plan-Do-Check-Act (PDCA) process preached so heavily in the standard itself. The Aerospace version (AS9100D) follows this same Annex SL and includes 100% of the requirements of ISO 9001. Because it is based on ISO 9001, we can probably expect a Revision E of AS9100 in 2027. It is my great hope that the powers that be with oversight into the development of ISO 13485 (medical) and IATF 16949 (automotive) will jump on the Annex SL bandwagon and align with ISO 9001. As most companies have multiple “merit badges” (QMS certifications) this would make integration much easier (but perhaps that would make too much sense!).

Anticipated Version 6 Changes
The upcoming revision of ISO 9001 aims to address several key areas to ensure the standard remains relevant in today’s rapidly changing business environment. Here are some predicted changes along with my personal thoughts:

• Enhanced risk management: Improvements in how organizations identify, assess, and manage risks. I would expect this to more closely align with the Aerospace AS9100 requirements and add an extra focus on minimizing the type of supply chain disruptions that crippled the industry during the COVID pandemic.
• Stakeholder: Greater emphasis on engaging with stakeholders to meet their needs and expectations. “Interested Party” feedback is a current requirement, but expect that to be an increased, more formalized focus going forward.
• Ethics and integrity: Within leadership practices, expect to see more recognition of the role of ethics and integrity in quality management. Ethical behavior is a current requirement but very lightly enforced, and it will be interesting to see how this element can effectively be measured.
• Digital innovation: Integration of digital technologies and practices to streamline processes, including the use of artificial intelligence (AI). I will have to wait to read the exact verbiage to understand how this can be applied to very small companies.
• Sustainability: To address environmental and social responsibilities, adopting greener processes, reducing waste, and ensuring ethical practices throughout the supply chain. ISO is doubling down and expanding on the climate change amendment. We have a standalone standard, ISO 14001, the internationally recognized standard for environmental management systems (EMS), so I am not sure why the need to include this in 9001.
• Cybersecurity: This has been an afterthought in the current standard, so expect a requirement to strengthen your cybersecurity measures to protect sensitive data and ensure the reliability of the quality management system documentation and data. Having a number of clients that have been cyber hacked, some with devastating consequences, I am in total agreement with this addition. 
• Implementation flexibility: This is a greatly welcomed addition that will allow a more tailored approach to documentation and process control requirements and implementation. Scalability of the QMS to align with the size of the company just makes so much sense and may provide relief to small businesses.

The new revision is designed to keep the standard relevant and effective in the face of modern challenges and “ripped from the headlines” global events from the last few years. By proactively adapting to these changes, organizations can not only maintain compliance but also enhance their overall quality management capabilities, leading to better performance and competitive advantage. Once released, we can begin doing Gap Analyses and planning the transition to the new Version 6 of ISO 9001.

This column originally appeared in the August 2025 issue of PCB007 Magazine.