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    News and Commentary on ISO Management System Standards

    20 Jan 2026

    ISO 13485 Risk Evaluation in Medical Devices explained

    ISO 13485

    QMSR & ISO 13485: On 02-Feb-26, the FDA Final Rule comes into force. The amendments incorporate by reference (and so align more closely with) the international standard ISO 13485:2016, Medical Devices - Quality Management Systems - Requirements for regulatory purposes. Two distinct and different requirements in ISO 13485:2016 for the management of risk. From Dr John FitzGerald: Misinformation ...
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    13 Jan 2026

    Environmental Aspects - the ISO 14001 requirements

    ISO 14001

    Systematically identifying relevant ISO 14001 environmental aspects in implementing an EMS. This is fundamental to the effectiveness of an Environmental Management System (EMS) and to ensuring that your organization meets ISO 14001 certification requirements.
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    08 Jan 2026

    ISO 9001 Documentation: DOs and DON'Ts

    ISO 9001

    An ongoing series of Posts: Practical advice on ISO 9001:2015 Clause 7.5, Documented Information The standard refers to documentation in general, not to documents (statements of intent, subject to change) or records (a history of what we have done and may not be changed). Good document control can, therefore, be challenging. In this post, we set out what constitutes best practice. NOTE: The ...
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    30 Dec 2025

    ISO 9001 Competence & Awareness: DOs and DON'Ts

    ISO 9001

    Practical advice on ISO 9001:2015 Clauses 7.2, 7.3, and 7.4 ISO 9001 Clauses 7.2, 7.3, and 7.4 are critical to the effective implementation and maintenance of an organization's Quality Management System (QMS). ISO 9001 Clause 7.2 emphasizes the importance of having competent personnel within an organization. ISO 9001 Clause 7.3 emphasizes the importance of ensuring that all employees are aware of ...
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    25 Dec 2025

    The 20 official ISO 9001 Guidance Documents

    Documentation

    A 'must read' for Consultants, Lead Auditors & other CB officers The ISO Technical Committee 176 (ISO/TC 176) on Quality Management, the committee responsible for the ISO 9000 family of Quality Management System (QMS) standards, also publishes many supporting documents (Guidance Documents) to support the implementation and improvement of effective quality management systems. Some of these ...
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    16 Dec 2025

    Cybersecurity for Medical Devices

    ISO 13485, ISO 27001

    QMSR & ISO 13485: On 02-Feb-26, the FDA Final Rule comes into force. The amendments incorporate by reference (and so align more closely with) the international standard ISO 13485:2016, Medical Devices - Quality Management Systems - Requirements for regulatory purposes. Did you know that cybersecurity is addressed in ISO 13485:2016, Clause 7.3? Whether you are marketing a Medical Device ...
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    27 Nov 2025

    ISO 9001 Knowledge Management - DOs & DON'Ts

    ISO 9001, ISO Standard Implementation

    Practical advice on ISO 9001:2015 Clause 7.1.6 Generally speaking, this requirement in ISO 9001:2015 needs to be addressed more effectively, and, more importantly, the valuable opportunity it provides is often overlooked. Too often, a 'throw-away' statement in a quality manual is used here without any serious consideration of the consequences to the business of the loss of knowledge that ...
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    20 Nov 2025

    Swiss Cheese Model of Risk Mitigation explained

    Risk Management

    Which is better when it comes to risk reduction: One major risk control that is 95% effective OR 4 minor controls, each of which is 60% effective? In applying ISO/IEC 27001:2022 to an information security management system (ISMS), one of the requirements in Clause 6.1.3.c) states: 'Compare the controls determined in 6.1.3 b) above with those of Annex A and verify that no necessary controls have ...
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    30 Sep 2025

    Open Letter to ISO/TC 176 regarding the ISO 9001 Revision

    ISO 9001

    Ladies & Gentlemen of ISO/TC 176, I wrote this letter in May 2024, hoping that it might receive some attention. But no. The current DIS contains no significant improvements and, taken at face value, appears to be solely for financial gain, offering nothing to restore the esteem in which the ISO 9001 Standard was once held, nor does it provide tangible benefits to certified organizations and ...
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    25 Sep 2025

    FDA QMSR and ISO 13485 – what you need to know

    ISO 13485

    On 02-Feb-26, the FDA Final Rule, amending the Current Good Manufacturing Practice (cGMP) requirement of the Quality System Regulation (QSR) of medical device manufacture, comes into force. The amendments incorporate by reference (and so align more closely with) the international standard ISO 13485:2016, Medical Devices - Quality Management Systems - Requirements for regulatory purposes. The new ...
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    Last Modified: January 8, 2026

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