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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

    Managing residual risk and understanding risk tolerance are crucial aspects of ISO 13485 compliance. ISO 13485:2016 is an international standard that outlines the requirements for a quality management system (QMS) in the medical device industry. Clause 7.1 requires risk management in relation to operations and, in a note (not, therefore, a requirement), refers to ISO 14971. How, then, should you ...
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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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    08 Aug 2024

    ISO 13485 Risk Evaluation for Medical Devices explained

    ISO 13485

    There are two distinct and different requirements in ISO 13485:2016 for the management of risk. From Dr John FitzGerald: Misinformation about risk management is already too easy to find regarding the adoption of ISO 13485 in the FDA's QMSR regulations, which will come into force in February 2026. If you follow the advice of these self-appointed experts, you will likely become confused and perhaps ...
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    13 Jun 2024

    ISO 9001 Analysis and Evaluation - DOs and DON'Ts

    ISO 9001

    Practical advice on implementing ISO 9001:2015 Clause 9.1.3 This article will consider a sub-clause in ISO 9001 Part 9, Performance Evaluation, of the Quality Standard, namely, 9.1.3, Analysis & Evaluation. NOTE: While the exact wording may differ from Standard to Standard, the advice given here also applies to ISO 14001, ISO 27001, ISO 45001, and other standards that have the same HLS ...
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    08 May 2024

    Open Letter to ISO/TC 176 regarding the ISO 9001 Revision

    ISO 9001

    Ladies & Gentlemen of ISO/TC 176, With renewed dismay, I read of the contents of ISO/CD 9001:2024 (albeit a leaked copy from a usually reliable source). It seems we have another revision that will do nothing to restore the esteem in which the ISO 9001 Standard was once held and nothing to provide tangible benefits to certified organizations and their customers. So, I challenge you to make ...
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