https://my.asq.org/events/event-description?CalendarEventKey=c76a99bf-c872-46f1-ba64-019c28bf2748
Date: 26 Mar 2026; Thursday 5:45 pm to 7:00 pm US-MT
5:45 pm Web Conference Start: Networking, Welcome and Section Business
6:00 pm Presentation Started
· Speaker: Bob Napoletan, ASQ Syracuse Section Chair
· Topic: ISO 9001:2026, 14001:2026 Changes
· NOTE: Recording (52 MB) and slides (0.5 MB) only access via ASQ National Membership
· NOTE: Non-ASQ Members to get slides please contact Arnold Miller via amiller@memberleader.asq.org
· Presentation Recording and sides at https://my.asq.org/viewdocument/2026-03meeting-iso-9001-2026-changes
· Non-ASQ Members Webex AI Summary at https://my.asq.org/blogs/arnold-miller/2026/03/27/boulder-mar-2026-meeting-iso-90012026-140012026-ch
6:55 pm Presentation Ended
7:00 pm Web Conference End: meeting over
References:
Please send presentation comments to Bob Napoletan at email rndquality@hotmail.com with subject “ASQ Boulder talk: ISO 9001:2026 Changes”
AI Notes Overview
· The meeting, led by Bob Napoletano, Syracuse section chair, focused on the upcoming ISO 9001:2026 revision. Bob provided a comprehensive historical context and detailed the key changes, emphasizing that the revision is evolutionary rather than revolutionary. Major updates include integration of climate considerations, enhanced focus on quality culture and ethics, clarified risk and opportunity management, and expanded employee awareness requirements. Clause-specific changes were outlined, highlighting leadership's increased accountability and the structured approach to risks and opportunities.
· Bob also discussed updates to the ISO 9000 terminology standard and the impact of ISO 9001 changes on related industry-specific standards such as AS9100, IATF 16949, and ISO 13485. Transition guidance was provided, advising organizations to await the final standard before making changes, with a transition period extending to 2029. The discussion included the harmonization of standard structures across industries and the rationale behind including ethics and quality culture as leadership responsibilities.
· Participants raised questions about the timing of updates for AI and digital transformation, to which Bob responded that these are likely to be addressed in future addenda due to the rapid pace of technological change. The session concluded with logistical announcements about upcoming meetings and resources, including access to the presentation materials and related webinars. Overall, the meeting equipped attendees with a clear understanding of the forthcoming ISO 9001 revision and practical steps for preparation.
AI Notes Detailed Summary
· ISO 9001 Revision Overview
· Bob Napoletano, the Syracuse section chair, presents an overview of the upcoming ISO 9001:2026 revision, highlighting that the revision process has taken 11 years, longer than the usual 5-year cycle. He emphasizes that the changes are not radical but include minor requirement updates and expanded guidance, with the new version expected in October 2026.
· Bob Napoletano explains the 2026 ISO 9001 revision has taken 11 years, longer than the typical 5-year cycle.
· He states the changes are minor and not radical, focusing on expanded guidance and some requirement clarifications.
· The new version is expected to be released in October 2026.
· Historical Context of ISO 9001
· Bob provides a historical background of ISO 9001, tracing its evolution from multiple standards in 1987 to the consolidated version in 2000 and subsequent revisions. He notes the introduction of risk-based thinking in 2015 and the reduction in required documented procedures over time, illustrating the standard's adaptation to organizational needs.
· Bob notes ISO 9001 started as multiple standards in 1987 and consolidated into one in 2000.
· The 2015 revision introduced risk-based thinking as a key concept.
· The number of required documented procedures has decreased from around sixteen to three or four over time.
· Key Changes in 2026 Revision
· The 2026 revision introduces integration of climate considerations, enhanced focus on quality culture and ethical behavior, clarified risk and opportunity management, and expanded employee awareness requirements. These changes aim to align the standard with contemporary organizational and environmental challenges while reinforcing leadership's role in quality management.
· Integration of climate considerations is added in the context of the organization clause.
· Leadership clause now emphasizes quality culture and ethical behavior.
· Risk and opportunity management is clarified with a more structured approach.
· Employee awareness requirements are expanded to include understanding of quality culture and ethics.
· Clause-by-Clause Changes
· Bob details anticipated changes across ISO 9001 clauses, including minor refinements in context of the organization, leadership accountability enhancements, clearer separation of risk and opportunity actions in planning, new awareness requirements in support, minimal changes in operation, and additional guidance on continual improvement linked to leadership.
· Clause 4 includes climate change considerations and minor refinements.
· Clause 5 emphasizes leadership accountability and quality culture.
· Clause 6 separates risk and opportunity management into distinct subclauses.
· Clause 7 adds awareness requirements about quality culture and ethics.
· Clause 8 sees minimal changes with some terminology updates.
· Clause 10 links continual improvement closely with leadership involvement.
· ISO 9000 Terminology Updates
· The ISO 9000 standard, serving as the terminology guide for quality management, is also being updated with 86 new terms and reorganized sections to clarify quality management principles and concepts. This update supports clearer understanding and implementation of ISO 9001 requirements.
· ISO 9000 adds 86 new terms relevant to quality management.
· Sections are reorganized to distinguish principles from concepts.
· The update aims to improve clarity and usability for quality management system users.
· Impact on Related Standards
· Bob discusses how changes in ISO 9001 will influence related standards such as AS9100 for aerospace, IATF 16949 for automotive, ISO 13485 for medical devices, and ISO 14001 for environmental management. These standards typically adopt ISO 9001 revisions with some delay and may include industry-specific additions.
· AS9100 is expected to update to align with ISO 9001:2026 around 2027.
· IATF 16949 and aerospace standards will likely follow a similar timeline.
· ISO 13485 may align more closely with ISO 9001 in future revisions.
· ISO 14001 will update concurrently with ISO 9001.
· Transition and Implementation Guidance
· Organizations are advised not to make premature changes before the final standard is published. Current ISO 9001:2015 certifications remain valid until 2029, with a three-year transition period thereafter. Bob recommends conducting gap analyses post-publication, educating personnel, and involving leadership in preparing for the new requirements.
· Do not implement changes based on the draft international standard prematurely.
· Current certifications remain valid until 2029 with a transition period to the new standard.
· Gap analyses should be conducted after the final standard is published.
· Leadership engagement and staff education are critical for successful transition.
· Discussion on Standard Structures and Industry Specifics
· Participants discuss differences between ISO 9001 and other standards like ISO 13485 and AS9100, noting that ISO 9001 is generic and applicable across industries, while others are industry-specific with unique structures. The trend is toward harmonizing structures for easier integration and auditing.
· Kathy Biehl notes preference for ISO 13485 structure due to familiarity.
· Bob explains ISO 9001's generic applicability across industries.
· AS9100 and IATF 16949 embed ISO 9001 structure with additional requirements.
· Efforts are underway to harmonize quality management standards' structures internationally.
· Ethics and Quality Culture Inclusion
· The inclusion of ethics and quality culture in the new ISO 9001 revision stems from international consensus among member countries. These elements are emphasized as leadership responsibilities and integral to sustained organizational success and reputation management.
· Ethics inclusion resulted from agreement among ISO member countries.
· Quality culture and ethical behavior are highlighted in leadership clauses.
· These aspects are linked to organizational reputation and sustained success.
· Future Considerations: AI and Digital Transformation
· The current 2026 revision does not address emerging technologies like artificial intelligence or digital transformation. Bob speculates that due to rapid technological changes, future addenda or revisions may incorporate these topics to keep the standard relevant.
· No significant new requirements for AI or digital transformation in 2026 revision.
· Bob anticipates possible addenda before the next full revision to address AI.
· Organizations should monitor developments for future standard updates.
DONE