News and Commentary on ISO Management System Standards

24 Oct 2021

6 Improvements to Make When Reviewing the QMS - ISO 9001 Clause 9.3.1

The periodic management system review is an opportunity not to be missed ISO 9001 Clause 9.3.1 requires that  'Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness.' Is this just a 'rubber stamp' activity or do you seek to benefit from the requirement?  In this post, we suggest the latter.
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22 Oct 2021

Managing Information Security Risks with ISO 27001 Certification

  What would you do if: You received a personal email demanding £10,000 so that you and your staff might regain access to your own computer system (ransomware attack).   The innovative ideas incorporated into your new product range are already known to Competitors who are already incorporating them into their products (cyber or old-fashioned espionage).   A major marketing launch is being ...
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22 Oct 2021

ISO 17025 Accreditation: 21 FAQs answered

We've gathered in this post all the commonly asked questions about ISO 17025 Accreditation together with expert answers.  Here are those questions: What is ISO 17025? What is ISO? What is the purpose of ISO 17025? What is ISO 17025 Accreditation and the Scope of that accreditation? Do You Need ISO 17025 Accreditation? How much does ISO 17025 Accreditation Cost? Who Issues ISO 17025 Accreditation ...
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15 Oct 2021

IVDR Transition Deadline extended up to 2027 – reality bites

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12 Oct 2021

deGRANDSON is now a world-class ISO 21001 Certified Trainer

deGRANDSON's Certification was confirmed by an independent audit and is valid until October 2024
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11 Oct 2021

Why ISO 21001 and not ISO 17024 or EXEMPLAR or IRCA Approvals?

  We hold ISO 21001 Certification for our e-learning business, and this was a considered choice. We started by asking what would be the best choice for Lead Auditors, Consultants and others wishing to audit, implement or maintain ISO Management Systems to a high standard.  From August 2015 to August 2021 we held certification from BQAI, an accredited Certification Body, for ISO 29990. a ...
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08 Oct 2021

Audit Evidence for ISO 27001 Annex A Compliance

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07 Oct 2021

ISO 13485 and Supplying to the Medical Device Sector: 9 FAQs

  Many organisations 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 ...
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05 Oct 2021

ISO 14971 - FMEA alone is not enough

The requirement is for a product lifecycle approach. i.e. from initial concept to end-of-life disposal
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21 Sep 2021

ISO 13485:2016 significantly amended – Amendment 11 published Sep 2021

An 'Informative' Amendment that must not be ignored
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