• Risk-Based Approach as Clear as Mud

    16 January, 2018 by Michelle Lott, Principal and Founder, Lean RAQA Systems

    This is the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” If you missed the first installment, catch up by reading it here. This post explores how the Practical Guide defines “risk-based approach,” varying terminology, and which systems require it.

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  • The Practical Guide to the ISO 13485:2016 Practical Guide

    5 December, 2017 by Michelle Lott, Principal and Founder, Lean RAQA Systems

    Manufacturers everywhere have been waiting a year and a half for additional guidance on the requirements of ISO 13485:2016, hoping September’s release of the "ISO 13485:2016 – A Practical Guide" (hereafter known as the “Practical Guide” or “Guide”) would bring the “practical” guidance promised.

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  • Understanding the Use of “Where Appropriate/As Appropriate” Within the ISO 13485:2016 Standard

    12 September, 2017 by Christine Park, Consultant, Christine Park & Associates

    Historically, the term “where appropriate” and/or “as appropriate” have been implied within the ISO 13485 standards as well as the FDA 21 CFR 820 Quality System Regulations. The FDA has always explained that “as appropriate” means it is appropriate unless you can justify why it isn’t appropriate.

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  • ISO, Regulatory Requirement Changes Loom

    1 September, 2017 by B. Christine Park, Consultant, Christine Park & Associates

    As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes.  Here are a few of the recent changes:

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