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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

    07 Dec 2024

    Preparing for an ISO 14001 Certification Audit

    ISO 14001

    A successful ISO 14001 audit is the foundation for certification to this globally-recognized environmental standard. These audits verify compliance with the standard's requirements and with applicable environmental laws and regulations. Certification also helps reduce your environmental footprint and optimize the resources used, potentially leading to cost savings and helping avoid costly fines. ...
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    29 Oct 2024

    ISO Auditor Competence: who decides on it?

    Being in a professional ISO auditor register isn't enough Competence is defined as the ‘ability to apply knowledge and skills to achieve intended results.’ And so it is with ISO Auditor Competence. Your Lead Auditor Certificate alone does not ensure competence. Nor, when competent, do you suddenly become incompetent three years after receiving your certificate. Confused? Don't be. For Lead ...
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    24 Oct 2024

    Medical Devices: Managing Residual Risk and Risk Tolerance

    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. Managing residual risk and understanding risk tolerance are crucial aspects of ISO 13485 compliance. ISO 13485:2016 is an ...
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    22 Oct 2024

    ISO 27001 in Manufacturing & Service Industries - 12 FAQs

    ISO 27001

    Have you considered this possibility? If you wait until this message greets you at work, a Notebook PC is stolen from a company vehicle, or staff members are working on their own PCs from home, it will be too late. It's not a question of whether your business will be targeted. You're already a target but have been lucky to date.
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    17 Oct 2024

    ISO Accreditation vs ISO Certification: what's the difference?

    Other Topics

    You've got the Certificate, but are you certified to the ISO Standard or accredited? It may seem unimportant in the scheme of things, but people, like potential customers, will judge you based on your correct use of technical and allied terms.
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    15 Oct 2024

    10 Reasons Why ISO 14001 Matters to SMEs

    ISO 14001

    Even the smallest organization has a lot to gain from a certified Environmental Management System (EMS) New businesses often ponder the benefits of ISO 14001 Certification and, being busy with start-up priorities, postpone certification until it is asked for in a tender document or by a prospective customer. At that point, it is, of course, too late. Optimistically, getting certified takes at ...
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    08 Aug 2024

    The Climate Change Amendment to ISO Management System Standards

    Other Topics

    The ISO Committee for Conformity Assessment (CASCO) has added a reference to “climate change” within all management systems standards operating according to Annex SL. What is ISO 9001:2015, Amendment 1:2024 They have stated that this is a clarification rather than a new requirement. Therefore, the publication year of the affected Annex SL standards will not change. As a ‘clarification,’ there is ...
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    25 Apr 2024

    Measuring Information Security Effectiveness with ISO 27004

    ISO 27001

    ISO 27001 provides no guidance and is of little help In deciding what to monitor and measure regarding your Information Security Management System (ISMS), ISO 27001 specifies no mandatory requirements (as emphasized in our ISO 27001 training courses). Thankfully, ISO 27004 provides guidelines and principles for measuring and reporting the effectiveness of an organization's ISMS. The standard ...
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    23 Apr 2024

    Safety Calendar for May

    ISO 45001

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    21 Sep 2023

    PRRC: Are you in breach of the EU MDR and IVDR Requirement?

    ISO 13485

    The EU MDCG 2019-7 provides guidance on "Persons Responsible for Regulatory Compliance’ (PRRC). The European Commission (EC) has published MDCG 2019-7, Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC). Meeting the requirements here will challenge SMEs and start-ups, but ...
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    Last Modified: February 5, 2026