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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

    24 Jul 2025

    ISO 9001 Risks and Opportunities - DOs and DON'Ts

    ISO 9001:2015 Clause 6.1, Actions to address risks and opportunities - Practical Advice Planning has always been a significant element of ISO 9001. In the 2015 Edition, there is an increased focus on ensuring that Clauses 4.1, ‘Context of the organisation’, and 4.2, ' Interested Parties’, are considered. Clause 6.1 requires that both the risks and the opportunities arising from Clauses 4.1 and ...
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    22 Jul 2025

    ISO Certification Body - time to switch?

    It isn’t just about getting an ISO Certificate. Your organization needs to derive value from the Certification Body Audits, and if it doesn’t, it should consider moving to another Certification Body. We at deGRANDSON Global are regularly asked about a policy for changing Certification Bodies. Certification Body (CB) contracts are of three years' duration. This is the universal norm. ...
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    17 Jul 2025

    ISO 13485, a global requirement in Medical Device Regulations

    ISO 13485

    ISO 13485 Certification has the potential to greatly benefit financially all businesses involved in the Medical Device Supply Chain While ISO 13485 certification is currently not a requirement in some countries, it is rapidly becoming a de facto worldwide regulatory requirement. You will not do business internationally or avoid unnecessary regulatory inspection without it.
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    15 Jul 2025

    ISO 14001 and securing Net Zero

    ISO 14001

    Increasing environmental concerns and the urgent need to combat climate change are prompting organizations worldwide to seek ways... - not only to reduce their environmental impact - but also to work towards achieving a net-zero footprint or, at the very least, carbon neutrality. Note: We refuse to use the term 'sustainability' because it has been so widely abused as to become meaningless. Many ...
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    10 Jul 2025

    ISO 13485: Critical Subcontractors and Crucial Suppliers

    ISO 13485

    Suppliers to the Medical Device Sector can get surprise visits too! EU Regulations, EN Standards, Notified Body activities (including Surprise/Unannounced Audits), UK Regulations post-Brexit, and MDSAP – all are changes that can impact your company’s Medical Device Management System (MDMS). What strategy should you, as a supplier to the sector, adopt to implement the ISO 13485 Standard and to ...
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    07 Jul 2025

    ISO 45001 Consultancy: Be a successful OH&S Consultant

    ISO 45001

    Could you make a successful career in OH&S management consulting? What ISO 45001 training is needed? Dr John FitzGerald writes ... "Having worked for 28 years as a management system consultant, I've learned a lesson or two (including some bitter ones) on setting up and running a successful ISO 45001 consultancy business. So I'd like to share my experience with you in this article. This time, ...
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    03 Jul 2025

    FDA QMSR and ISO 14971: What you need to know

    ISO 14971

    Don't believe everything you read about ISO 14971! The FDA's 'Medical Devices; Quality System Regulation Amendments' website explicitly states: All sections of ISO 13485 apply to device manufacturers. While there is much mention of 'incorporating by reference' and many misguided interpretations of that phrase, don't let anyone mislead you. To reiterate, the FDA's website explicitly states that ...
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    25 Jun 2025

    Information Security Standards other than ISO 27001

    There are many popular data security standards other than ISO 27001 Frequently, cybersecurity standards other than ISO 27001 and the 47+ subsidiary standards of the ISO 27000 series are incorporated into Information Security Management Systems (ISMSs). Auditors of ISMS and those negotiating with customers on information security issues need knowledge of and the use/application of these standards. ...
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    24 Jun 2025

    CPD - Continued Professional Development - for all

    Free Continued Professional Development Model from deGRANDSON Global CPD is an ongoing process essential for maintaining professional standards and enhancing career development. By systematically engaging in CPD, you can ensure you remain competent, competitive, and capable of providing high-quality services in your chosen field. But why does CDP Matter so much?
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    19 Jun 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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