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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

    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

    Did you know that cybersecurity is addressed in ISO 13485:2016, Clause 7.3? Whether you are marketing a Medical Device Software (MDSW) product or a medical device where software drives or influences the device, you face cybersecurity issues. In EU-regulated countries, the AI Act is a factor to consider; however, as it has been deferred to 2027, it is a topic for another day and is not considered ...
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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

    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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    16 Sep 2025

    Preparing for your first ISO 13485 Certification Audit

    ISO 13485

    Your old ISO 9001 QMS 'dolled up' with the language of the 2016 Standard is not going to be adequate. When you are first audited against ISO 13485:2016, the Auditors, whether a Notified Body or Certification Body, will, as usual, be seeking objective evidence of your compliance with the Standard. Being an audit against ISO 13485, a different style of Quality Management System standard, the extent ...
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    02 Sep 2025

    ISO 13485 What New Suppliers to the Medical Device Sector Need to Know

    ISO 13485

    Great opportunities for Suppliers to the Medical Device Sectors on both sides of the Atlantic. In February 2026, the FDA adopts ISO 13485 as part of the new QMSR regulations. You can anticipate that Medical Device manufacturers will be asking their suppliers to get ISO Certification. This is not a regulatory requirement but provides a kind of 'security blanket'. In Europe, a similar scene with ...
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    28 Aug 2025

    ISO 27001 Implementation Errors You Need to Avoid

    ISO 27001

    Securing certification to this Information Security standard requires a collective effort. Implementing ISO 27001, the international standard for Information Security Management Systems (ISMS), can be complex, and several common errors may need to be corrected during the implementation process.
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    22 Aug 2025

    [Video] deGRANDSON Global Courses explainer

    ISO 27001

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