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  • Expert perspective on ISO 9001:2026 transition – Sanity check on Gap Analysis and strategic shift

    Hello everyone,

    My name is Radim V., and I’ve spent over 15 years in quality management, focusing on QMS implementation, lead auditing, and guiding organizations through complex certification cycles.

    As we move closer to the release of ISO 9001:2026, I have been mapping out the anticipated structural changes and their impact on existing documentation. I am particularly focusing on how the new version will integrate emerging trends like digitalization and supply chain resilience beyond the current 2015 framework.

    I’ve been synthesizing my thoughts based on a comprehensive roadmap and a preliminary Gap Analysis I found here: https://certifikace.eu/iso-9001-2026/

    (Note: The resource is in Czech, but the technical terminology is very precise and browser auto-translate handles it perfectly for English speakers.)

    I would value your expert opinion on a few points I’m currently weighing:

    Documentation Leaner-ness: Do you agree that the 2026 version will push for even less "paperwork" and more integrated digital evidence, as suggested in the linked Gap Analysis?
    Risk-Based Thinking Evolution: I’m interpreting the upcoming changes as a shift from "preventive" to "resilient" management. Does your interpretation of the current drafts align with the impacts on documentation described in the resource?
    Transition Timing: Based on your experience with the 2015 transition, do you find the proposed timeline (transition until 2029) realistic for global supply chains?
    I am trying to ensure that my strategic approach for my clients is proactive rather than reactive. I’d appreciate any feedback on whether my reasoning—and the points raised in the mentioned analysis—align with what you are seeing in the international technical committees.

    Looking forward to a professional exchange.

    Best regards,

    Radim V.

  • ISO 9001 Quality Inspection Records

    We have some standard quality inspection records.  Basically they are spreadsheets that have a checklist for each product we make where we verify our product meets specifications (for example, height, weight, etc) and then we mark down whether it’s passed or not. Do these inspection records need to be considered as controlled documents?  Do they need to be given a document number, revision level, and approval?  Do they need to be kept on the document control master list?

  • ISO 9001:2015 and the Accounting department

    For ISO 9001-2015 does this standard covers for the whole organization which include accounts department? If yes which all ISO clause we need to use for accounts department?

  • Who should prepare the Quality System documentation?

    I want to know who usually should do the documentation work for a quality system? QC officer or internal auditor?  I want to know the position that prepare these ISO documents.

  • ISO 9001 - Company's organization log

    I came from a company that was ISO 13485 certified and there, as doc control, I maintained a form log that designated form numbers to all forms used within the organization. I have since moved on to a new company that retains only an ISO 9001 certification, but my question is, is it necessary to still retain this kind of specificity to the forms used? For example, should the company's organization log contain a form number and revision, and have a log as to when it was created and by whom? Or is it alright to have it posted without any of that identity as a free standing document? I ask this because as I perform an internal audit on a give process, I find myself needing to reference their org chart, but am hazy as to how controlled it needs to be. Does this make sense? Please advise.

  • ISO 9001 and fertility centers

    Is ISO 9001 certificate valid for fertility centers?"

  • Integrating ISO 14001 & ISO 45001 into ISO 9001

    A client has iso 9001 and he needs implement iso 45001 & iso 14001. What documents I should to ask him and how we will give him implement those iso?