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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.

  • Are the trainings available in other languages?

    Dear all, Are the trainings available in other languages? i would like to suggest to my colleagues but they only speak french

  • Question on large/small business certification

    I am contracted with a big business which has many contracts. Our contract ISO certified but we are partnering with a small business for my contract. I am the lead auditor and if I am transfered to the small business with our contract will the big business still be ISO certified?

  • QMS Scope for Food Product Distribution - Can I Limit It?

    Hi everyone, I'm setting up a Quality Management System (QMS) for my food product distribution business and have a question about defining the scope. We sell and distribute to both retail (supermarkets, small stores) and foodservice (restaurants, manufacturers). My main question is: Can I limit the products covered by my QMS? For example, if I sell orange juice, coffee powder, and milk powder, can I choose to only include the coffee and milk powder in the QMS scope? Is this a common or recommended practice? Any advice on defining the scope of my QMS in this situation would be greatly appreciated!

  • Collated Nonconformances

    Hi! I'm quite new to ISO 9001:2015. I am currently designated as the Lead Internal Quality Auditor in our company. I would like to know who will be responsible or tagged for collated Nonconformances for each clause in 9001:2015? Thank you in advance for your replies.

  • Documentation Hierarchy

    Hi I need support to organise and map organisation documentation. How it should be organised as mandatory corporate documents

    Level 1 documents

     1 Manuals
    1.2 Policy
    1.3 Strategy
    1.4 Main Process Titles
    1.5 Sub-Process

     

    or shall we have policy first and them manuals. What is the diffrence between policy and manual?

     

    Thanks

  • Internal Audits

    What is the importance of internal audit findings while preparing iso IMS certification?

  • Sustainability and Environmental Management

    What would I say to the directorate and or business owner to convince them that sustainability and environmental management need to be at the forefront of the business? particularly when considering 2030 and 2050 targets.

  • Specific pharma industry question

    Detailed risk management Examples in the solid dosage forms manufacturing processes. e.g cross contamination & cleaning validation.

  • Will ISO 9001:2015 be updated until 2030?

    I have a question about the status of ISO 9001:2015 and whether it will continue to be in effect without any modifications or if there is a new version that supersedes it. Specifically, I would like to know if the latest version, ISO 9001:2015, will remain valid until the year 2030.

    Your clarification on this matter would be greatly appreciated, as it will help us ensure our compliance and quality management systems align with the current ISO standards.
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