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    News & Commentary on ISO Management System Standards

    News and Commentary on ISO Management System Standards

    29 Apr 2025

    Unannounced Audits by Notified Bodies: What you need to Know

    If your company supplies components or materials to an EU medical device manufacturer, here is the information you need to be aware of, as outlined in the ISO 13485 Regulations. And it's about unannounced audits of your business by Notified Bodies.
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    22 Apr 2025

    Why Lab Management and Accreditation to ISO 17025 Matters

    Clearly defined and strictly followed laboratory quality controls are a must when offering laboratory services of any kind. New businesses rarely ponder the benefits of being accredited to ISO 17025 however, even the smallest organization has a lot to gain from an accredited Testing and/or Calibration Laboratory Management System (TCLMS). Startup priorities, and the fact that it takes a minimum ...
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    22 Apr 2025

    The IAF Logo on your ISO 13485 Certificate?

    The IAF MLA mark is now available to all CABs accredited by The European Cooperation for Accreditation (EA) Members and is recognized and accepted by all 563 IAF members from 81 countries.
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    22 Apr 2025

    Workplace Safety Overview

    Workplace safety is a crucial part of responsible business conduct and societal welfare involving workers, employers, governments, and the broader community. This article offers an overview of global workplace safety, covering the nature of work-related diseases, injuries, and illnesses, prevalent occupational health and safety (OHS) incidents, underlying issues leading to workplace safety ...
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    22 Apr 2025

    IVDR Transition Deadline extended up to 2027

    Despite repeated statements that the IVDR deadline of 26 May 2022 would not be extended, that is precisely what the European Commission did. Whilst just a proposal at the moment, ratification by the European Parliament and Council is just a formality and formal adoption by publication in the Official Journal of the European Union will follow.
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    22 Apr 2025

    IAF Accreditation is not available for all ISO Standards

    Only a limited number of ISO Management System Standards qualify for an IAF logo. We're all familiar with ISO 9001 Certificates carrying three logos, for example, the Certification Body logo (say, Lloyds Register), the Accreditation Body logo (say, UKAS), and the IAF logo. But the IAF logo doesn't appear on every Certificate. Why is that? And is it significant?
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    22 Apr 2025

    Correction vs Corrective Action vs Preventive Action

    Correction, Corrective Action, and Preventive Action (CCAPA) are essential management systems components that help organizations identify, address, and prevent issues to ensure ongoing process improvement.
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    18 Apr 2025

    ISO 9001 Planning for Changes: DO's and DON'Ts

    ISO 9001:2015 Clause 6.3 Planning for Changes - Practical Advice The purpose of Planning the Changes is to maintain the integrity of the quality management system and the organization’s ability to continue to provide conforming products and services during the change. And you will need records or other credible evidence to demonstrate compliance here. NOTE: The advice given here also applies to ...
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    10 Apr 2025

    ISO 14971: Risk Management for Medical Devices

    Using FMEA alone is a lazy choice and is 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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    08 Apr 2025

    Combining ISO 17025 and ISO 9001 for Laboratories

    It is not unusual for your lab to be simultaneously certified to both standards. But are you doing it effectively and efficiently? It's not uncommon for Laboratories to be certified to more than one Standard. For example, a Calibration Laboratory may be accredited to ISO 17025, the ISO standard for calibration of testing laboratories, and certified to ISO 9001, the ISO standard for quality ...
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