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

    13 Mar 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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    03 Mar 2024

    Scenarios are a 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

    What should you expect from a well-designed, well-developed, and well-delivered e-Learning Course? e-Learning had a bad reputation, and it was justified, but much has changed in recent years. Today’s online courses are usually a match for, and superior to, conventional training. And this, if for no other reason than for not being dependent on a presenter or tutor, lessons can be delivered to a ...
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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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    07 Dec 2023

    Managing Residual Risk and Risk Tolerance in Medical Devices

    ISO 13485:2016 is an international standard that outlines the requirements for a quality management system (QMS) in the medical device industry. Managing residual risk and understanding risk tolerance are crucial aspects of ISO 13485.
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    28 Nov 2023

    Ready to implement ISO 14001? Here's everything you'll need

    Get detailed guidance on ISO 14001 implementation. Our Lead Implementer Courses includes a free and comprehensive Documentation Toolkit all the procedures and forms you'll need to complete the job. This is documentation that others charge $750 or more for!
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    01 Nov 2023

    Ready to implement ISO 45001? Here's everything you'll need

    Our Lead Implementer Courses include a free and comprehensive Documentation Toolkit – all the procedures and forms you'll need to complete the job. This is documentation that others charge $750 or more for FREE! With our ISO 45001 Lead Implementer Course, you will get detailed step-by-step guidance to securing ISO 45001:2018 for your organization.
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