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    News & Commentary on ISO Management System Standards

    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

    18 Jun 2024

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

    Many organizations with the potential to supply components, packaging, and other goods and services (incl. logistics) to the Medical Device Sector are scared off by talk of CE Marking, Notified Bodies, regulatory inspections, unannounced/surprise audits, and the like. It's all nonsense (well, almost all). You don't believe me? Then read on. There could be a lot of high-margin business that you're ...
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    13 Jun 2024

    ISO 9001 Analysis and Evaluation - DOs and DON'Ts

    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

    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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    25 Apr 2024

    Measuring Information Security Effectiveness with ISO 27004

    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

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    04 Apr 2024

    Environmental Aspects - meeting ISO 14001 requirements

    Systematically identifying relevant ISO 14001 environmental aspects in implementing an EMS. This is fundamental to the effectiveness of an Environmental Management System (EMS) and to ensuring that your organization meets ISO 14001 certification requirements.
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    23 Feb 2024

    FDA QMSR and ISO 13485 – what you need to do

    On 02-Feb-24, the FDA published its Final Rule, amending the Current Good Manufacturing Practice (cGMP) requirement of the Quality System Regulation (QSR) of medical device manufacture. 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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    08 Feb 2024

    ISO 9001 and Quality System Documentation: DO's and DON'Ts

    An ongoing series of Posts: Practical advice on ISO 9001:2015 Clause 7.5, Documented Information. NOTE: The advice given here also applies to ISO 14001, ISO 27001, ISO 45001 and other standards having the same HLS structure as ISO 9001.
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    25 Jan 2024

    ISO 9001 Clauses 7.2, 7.3, and 7.4: DO's and DON'Ts

    Practical advice on ISO 9001:2015 Clauses 7.2, 7.3, and 7.4 ISO 9001 Clauses 7.2, 7.3, and 7.4 play a crucial role in the effective implementation and maintenance of a Quality Management System (QMS) within an organization. ISO 9001 Clause 7.2 emphasizes the importance of having competent personnel within an organization. ISO 9001 Clause 7.3 emphasizes the importance of ensuring that all ...
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    18 Jan 2024

    [Update 2024] Twenty official ISO 9001 Guidance Documents

    Must read for Consultants, Lead Auditors & other CB officers The ISO Technical Committee 176 (ISO/TC 176) on Quality Management, the committee responsible for the ISO 9000 family of Quality Management System (QMS) standards, also publishes many supporting documents (called Guidance Documents) to supplement the implementation and improvement of effective quality management systems. Most of ...
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