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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

    03 Mar 2024

    Scenarios are the key difference with deGRANDSON e-Learning

    All our Courses are true e-Learning and include extensive Scenarios The many short- and long-term scenarios presented are unique to e-learning with deGRANDSON Global. Altogether, they help bridge the void between theory learned in a classroom-like situation and the practice, and challenge, of face-to-face auditing. You get the opportunity to practice what you've learned before engaging in a ...
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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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    20 Feb 2024

    15 Myths about deGRANDSON e-Learning

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    13 Feb 2024

    Free ISO 13485 Implementation Handbook

    This 100+ page step-by-step guide is available free with our ISO 13485 Lead Implementer Course. It is not for sale. But it is everything you'll need to develop, implement, and maintain a management system to ISO 13485 Certification standard, including sample Procedures and Forms.
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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: As most ISO Management System Standards have the same High-Level Structure (HLS) and associated identical requirements as ISO 9001, the same interpretation as is given here can be applied to ISO 14001, ISO 27001, ISO 45001, and other ISO-based management systems.
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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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    23 Jan 2024

    ISO 14001 Certification: FAQs e-Book

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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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    16 Jan 2024

    ISO 17025 Accreditation: FAQs e-Book

    ISO 17025 is a bit different from other ISO standards. In this post, we'll discuss why as well as answer some other commonly asked questions about ISO 17025 accreditation. Download the Free e-book for the answers to 13 questions.
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    11 Jan 2024

    ISO 27001 Certification: FAQs e-Book

    Here we've gathered all the commonly asked questions about ISO 27001 compliance together with expert answers in this post. Download the Free ISO 27001 Certification ebook for answers.
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