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    News and Commentary on ISO Management System Standards

    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

    Errors to avoid in implementing ISO 27001

    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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    21 Aug 2025

    ISO Management System Revisions 2025-2030

    ISO 9001

    ISO 9001 and other Management System Standards, 2025 to 2030 While there are more than 50 ISO Management System Standards, only about twelve are frequently used. It is these few that we will concentrate on in this post. While many new revisions of these standards are planned, the nature and significance of those changes have yet to emerge. Much will depend on the new revision of ISO 9001, which ...
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    14 Aug 2025

    ISO 9001 Continual Improvement - DOs and DON'Ts

    ISO 9001

    Practical advice on ISO 9001:2015 Clause 10.3 The organization itself determines the rate, extent, and timescale of actions that support continual improvement. Quality Management System (QMS) performance can be enhanced by applying an improvement to the quality management system as a whole or improving one or more of its elements. Your ISO 9001 Implementation Project offers a real opportunity to ...
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    06 Aug 2025

    ISO 27001 can accommodate all Information Security Regulations

    ISO 27001

    ISO 27001 offers a comprehensive framework that can incorporate all information security regulations and schemes - GDPR, HIPAA, SOC 2, CCPA, etc. Information security/cybersecurity has become crucial to any organization's functioning in today's digital age. With the increasing amount of data and sensitive information being stored and transmitted through various digital channels, organizations ...
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    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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