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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

    15 Dec 2024

    The ISO Family of Environmental Standards

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    13 Dec 2024

    ISO 9001 Clauses

    Want the Helicopter view of ISO 9001? If yes, start here. ISO 9001 offers a comprehensive framework for establishing a solid Quality Management System (QMS). The key to this lies within its core clauses, a set of specific requirements that form the backbone of this standard. Let's look at each in turn to understand how they can transform your organization's approach to managing your business. ...
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    12 Dec 2024

    ISO 9001 Quality Objectives: DOs and DON'Ts

    Practical advice on ISO 9001:2015 Clause 6.2 implementation ISO 9001 Implementation frequently runs into difficulties when addressing the requirements of Clause 6.2. Here's how we think it should be done. 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 structure as ...
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    07 Dec 2024

    Preparing for an ISO 14001 Certification Audit

    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

    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

    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?

    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

    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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