News & Commentary on ISO Management System Standards

    News and Commentary on ISO Management System Standards

    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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    19 Mar 2024

    ISO 14971: Choosing the right Risk Management Tools

    Using FMEA alone is a lazy choice and no longer acceptable ISO 14971, Medical Devices - Application of risk management to medical devices is frequently misapplied, and if your ISO 13485 QMS Manual claims to use ISO 14971, you'd better use it properly.
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    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. 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 no transition period for the Amendment, ...
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    07 Mar 2024

    ISO 9001 Internal Auditing: DOs and DON'Ts

    Practical advice on ISO 9001:2015 Clause 9.2 NOTE: The advice here applies to all Management System Standards (MSS) and not just to implementing ISO 9001:2015. For whatever MSS you need to conduct internal audits, you have two basic approaches to choose from: Option 1: do the minimum necessary to satisfy the Certification Body (CB) [or Accreditation Board (AB)] Auditors Option 2: take the best ...
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    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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