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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

    25 Apr 2024

    Measuring Information Security Effectiveness with ISO 27004

    ISO 27001

    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

    ISO 45001

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    04 Apr 2024

    Environmental Aspects - meeting ISO 14001 requirements

    ISO 14001

    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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    08 Feb 2024

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

    ISO 9001

    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

    Documentation

    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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    21 Sep 2023

    PRRC: Are you in breach of the EU MDR and IVDR Requirement?

    ISO 13485

    The EU MDCG 2019-7 provides guidance on "Persons Responsible for Regulatory Compliance’ (PRRC). The European Commission (EC) has published MDCG 2019-7, Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC). Meeting the requirements here will challenge SMEs and start-ups, but ...
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    14 Sep 2023

    Cyber Security in Medical Device Management

    ISO 13485, ISO 27001

    Did you know that cybersecurity is addressed under ISO 13485:2016 Clause 7.3 requirements? The Royal Academy of Engineering (RAE UK) report ‘Cyber Safety and Resilience’ (March 2018) suggests that the healthcare sector can learn from other industries when it comes to guarding against ransomware attacks, data breaches and hacking of connected health devices. That was just the beginning. Since ...
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    11 Jul 2023

    ISO 9001 Knowledge Management - DOs and DON'Ts

    ISO 9001, ISO Standard Implementation

    Practical advice on ISO 9001:2015 Clause 7.1.6 This requirement in ISO 9001:2015 needs to be addressed more effectively, and more importantly, the valuable opportunity it provides is frequently ignored.
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    22 Mar 2023

    MDR Transition Deadlines extended to 2028

    ISO 13485

    But it’s complicated, required deadlines vary by Class and for all devices. You need to take action now or risk having no product to sell.
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