Author
Author
Steve Williams is the President of The Right Approach Consulting. He is also an independent certified coach, trainer, and speaker for the John Maxwell team.
The ISO 9001 international quality standard is revised every 5 to 7 years, but it has far exceeded this regular cycle. The latest revision is expected to be completed by the end of 2025 and implemented starting in 2026, and it will include many changes that are as significant as those in the current 2015 version.
ISO Revision History
The International Organization for Standardization (ISO) revises the ISO 9001 standard every 5 to 7 years.
The first revision was published in 1994, followed by a major overhaul in 2000. A revision was made in 2008, but it only included minor changes. The latest revision, ISO 9001:2015, was published in September 2015 and included the most significant changes. Here is a brief history of the revisions of ISO 9001:
ISO 9001: 1987: The initial version of the ISO 9001 standard originated from military quality standards, primarily focusing on manufacturing. Initially, there were three ISO series quality standards:
• ISO 9001: Design, new product development, production, and installation
• ISO 9002: All contents of ISO 9001, but without the new product development section
• ISO 9003: Final inspection and testing
ISO 9001: 1994: The first revision introduced the concept of preventive measures, rather than just checking the conformity of the final product.
ISO 9001: 2000: The second revision merged ISO 9001, ISO 9002, and ISO 9003 into a single, universally applicable standard and allowed for the exclusion of requirements that were not applicable to the organization.
ISO 9001: 2008: The 2008 revision introduced some new wording and clarifications but did not add new requirements.
ISO 9001: 2015: Currently, this is the latest revision of the standard, which introduced a new high-level structure (Annex SL) and included several new and modified requirements, most importantly the concept of risk-based thinking.
• In February 2024, ISO released the ISO 9001:2015/AMD1:2024 revision, modifying Chapter 4 to include considerations for climate action. (Anyone who knows me is aware of my views on this revision!)
The 2015 revision was ultimately refined by Annex SL, which provides a logically ordered set of requirements and follows the Plan-Do-Check-Act (PDCA) process strongly advocated by the standard itself. The aerospace version (AS9100D) follows the same Annex SL and includes all requirements of ISO 9001.
Since it is based on ISO 9001, we can predict that the revision of AS9100E will be released in 2027. I sincerely hope that the relevant departments responsible for the development of ISO 13485 (medical) and IATF 16949 (automotive) can keep pace with Annex SL and align with ISO 9001. This would make integration easier for most companies that have multiple “honorary certification certificates” (quality management system certifications), but perhaps that is too logical!
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Predicted Changes in Version 6
The upcoming revision of ISO 9001 aims to consider several key factors to ensure that the standard remains relevant in today’s rapidly changing business environment. Here are some predicted changes and my personal views:
• Enhanced Risk Management: Improving the way organizations identify, assess, and manage risks. I predict this will align more closely with the requirements of aerospace AS9100, with a particular focus on reducing supply chain disruptions similar to those caused by the COVID pandemic.
• Stakeholders: Greater emphasis on interaction with stakeholders to meet their needs and expectations. “Stakeholder” feedback is currently a requirement, but it is expected to become a more formalized concern in the future.
• Ethics and Integrity: In leadership practices, there is a prediction of greater recognition of the role of ethics and integrity in quality management. Ethical behavior is currently a requirement, but enforcement is light; we will see how effectively this element can be measured, which will be noteworthy.
• Digital Innovation: Integrating digital technologies and practices to streamline processes, including the use of artificial intelligence (AI). I will need to wait until the revision is officially released to read the specific wording to understand how this applies to very small companies.
• Sustainability: Adopting more environmentally friendly processes, reducing waste, and ensuring ethical practices throughout the supply chain to address environmental and social responsibilities. ISO is intensifying efforts and expanding climate change revisions. I understand that ISO 14001 is an independent, internationally recognized Environmental Management Systems (EMS) standard, so I do not quite understand why it needs to be incorporated into ISO 9001.
• Cybersecurity: Cybersecurity has been an afterthought in the current standard, so it is expected that new requirements for enhanced cybersecurity measures will be added to protect sensitive data and ensure the reliability of quality management system documentation and data. Given that I have multiple clients who have experienced cyberattacks, some of which have had catastrophic consequences, I fully support this new requirement.
• Implementation Flexibility: This is a highly welcomed new addition that will allow organizations to tailor documentation and process control requirements and implementation according to specific circumstances. The quality management system (QMS) can be scaled according to company size, which is very reasonable and can assist small businesses.
The new revision aims to address modern challenges and global events that have received significant attention in recent years, maintaining the relevance and effectiveness of the standard. By actively adapting to these changes, organizations can not only maintain compliance but also enhance overall quality management capabilities, thereby improving performance and competitive advantage. After the new standard is released, organizations can begin conducting gap analyses and planning for the transition to ISO 9001 Version 6.
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