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    News and Commentary on ISO Management System Standards

    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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    25 Sep 2025

    ISO 45001 Documentation Toolkit

    ISO 45001

    ISO 45001 Documentation Toolkits are vital for organizations that aim to establish and maintain Occupational Health and Safety Management Systems (OHSMS) that comply with the ISO 45001 standard.
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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

    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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