a
.

    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
    Find me on:
     

    Recent Posts

    16 Sep 2025

    Preparing for your first ISO 13485 Certification Audit

    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. Your old ISO 9001 QMS 'dolled up' with the language of the 2016 Standard is not going to be adequate. When you are first ...
    Read More
    02 Sep 2025

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

    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. Great opportunities for Suppliers to the Medical Device Sectors on both sides of the Atlantic. In February 2026, the FDA ...
    Read More
    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.
    Read More
    22 Aug 2025

    [Video] deGRANDSON Global Courses explainer

    ISO 27001

    Read More
    21 Aug 2025

    ISO Management System Standards 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 ...
    Read More
    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 ...
    Read More
    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 ...
    Read More
    24 Jul 2025

    ISO 9001 Risks and Opportunities - DOs and DON'Ts

    ISO 9001

    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 ...
    Read More
    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. ...
    Read More
    17 Jul 2025

    ISO 13485, a global requirement in Medical Device Regulations

    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. ISO 13485 Certification has the potential to greatly benefit financially all businesses involved in the Medical Device Supply ...
    Read More

    Last Modified: January 8, 2026

    Free ISO Standard Copy When You Buy Auditor Courses in January

     

    Subscribers get a 10% Discount

    Recent Posts

    Posts by Tag

    See all
    Already enrolled? YOUR LESSONS ARE HERE!

    Courses

    FAQs

    Other Information

    Contact Information

    • deGRANDSON Global UK
    • Adamson House, Towers Business Park, DIDSBURY M20 2YY
    • info@degrandson.com

     

    © 2026 · deGRANDSON Global.