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    ISO 13485 audit checklist

    An industry expert-made audit checklist to perform a high-level self-assessment of your compliance with ISO 13485:2016, ideal for internal audits, training, or QMS gap analysis.

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    ISO 13485 audit checklist | Scilife

    What's inside?

    This practical ISO 13485 audit checklist will help you:

    • Assess whether your QMS meets core requirements outlined in Clauses 4–8 of ISO 13485:2016.
    • Build tailored audit scopes, whether you're focusing on CAPA, production, or documentation.
    • Reference a side-by-side comparison of ISO 13485 vs. ISO 9001 to clarify overlapping and unique requirements.
    • Learn with clear explanations and real-life examples that make “industry speak” accessible.

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