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    News and Commentary on ISO Management System Standards

    Dr John FitzGerald

    Director & Founder of deGRANDSON Global. Spent 15 years in the manufacturing industry and 25 years training, consulting & auditing management systems
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    Recent Posts

    22 Apr 2025

    IVDR Transition Deadline extended up to 2027

    ISO 13485

    Despite repeated statements that the IVDR deadline of 26 May 2022 would not be extended, that is precisely what the European Commission did. Whilst just a proposal at the moment, ratification by the European Parliament and Council is just a formality and formal adoption by publication in the Official Journal of the European Union will follow.
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    22 Apr 2025

    IAF Accreditation is not available for all ISO Standards

    Other Topics

    Only a limited number of ISO Management System Standards qualify for an IAF logo. We're all familiar with ISO 9001 Certificates carrying three logos, for example, the Certification Body logo (say, Lloyds Register), the Accreditation Body logo (say, UKAS), and the IAF logo. But the IAF logo doesn't appear on every Certificate. Why is that? And is it significant?
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    22 Apr 2025

    Correction vs Corrective Action vs Preventive Action

    ISO Standard Implementation

    Correction, Corrective Action, and Preventive Action (CCAPA) are essential management systems components that help organizations identify, address, and prevent issues to ensure ongoing process improvement.
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    18 Apr 2025

    ISO 9001 Planning for Changes: DO's and DON'Ts

    ISO 9001

    ISO 9001:2015 Clause 6.3 Planning for Changes - Practical Advice The purpose of Planning the Changes is to maintain the integrity of the quality management system and the organization’s ability to continue to provide conforming products and services during the change. And you will need records or other credible evidence to demonstrate compliance here. NOTE: The advice given here also applies to ...
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    10 Apr 2025

    ISO 14971: Risk Management for Medical Devices

    ISO 14971

    Using FMEA alone is a lazy choice and is no longer acceptable ISO 14971, Medical Devices - Application of risk management to medical devices, is frequently misapplied, and if your ISO 13485 QMS Manual claims to use ISO 14971, you'd better use it properly.
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    08 Apr 2025

    Combining ISO 17025 and ISO 9001 for Laboratories

    ISO 17025, ISO 9001

    It is not unusual for your lab to be simultaneously certified to both standards. But are you doing it effectively and efficiently? It's not uncommon for Laboratories to be certified to more than one Standard. For example, a Calibration Laboratory may be accredited to ISO 17025, the ISO standard for calibration of testing laboratories, and certified to ISO 9001, the ISO standard for quality ...
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    01 Apr 2025

    [Infographic] The Route to ISO Certification

    The 12-step ISO Certification process is explained. Once your ISO Management System (ISO 9001, ISO 13485, ISO 27001, etc.) has been implemented, what are the next steps to achieving certification? Where does the Certification Body fit in Even though we're not a certification body, the deGRANDSON Global business primarily provides ISO training for auditors, so we'd like to give you a quick ...
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    27 Mar 2025

    Checking the Effectiveness of Corrective Action

    ISO Standard Implementation

    All ISO Management System Standards require that the effectiveness of Corrective Action be checked. It's rarely done well. Let's take ISO 9001:2015 as an example. Note: The process is identical for all the ISO Management System Standards, ISO 14001, ISO 45001, ISO 13485, etc. ISO 9001:2015 Clause 10.2, Nonconformity and Corrective Action, requires that when a nonconformity occurs, including those ...
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    25 Mar 2025

    Why ISO 21001 and not ISO 17024 or EXEMPLAR or IRCA Approval?

    Other Topics

    deGRANDSON Global holds ISO 21001 Certification, a university-grade accreditation, because it's the only one that matters. Without independent auditing to confirm compliance, it's only a badge! We started by asking what would be the best choice of Learning Provider qualification for Lead Auditors, Consultants, and others wishing to audit, implement, or maintain ISO Management Systems to a high ...
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    18 Mar 2025

    ISO 9001 Consultancy: do you have a future as a QMS Consultant?

    ISO 9001

    Quality Management System consultants are professionals or consulting firms specialized in assisting organizations in implementing, maintaining, and improving their Quality Management Systems (QMS) in accordance with the ISO 9001 standard. 
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