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  • ISO13485-2016 Mindmap EN

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    Bala Murali
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    ISO13485-2016_Mindmap_EN

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    14 views1 page

    ISO13485-2016 Mindmap EN

    Uploaded by

    Bala Murali

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    1 Scope

    Annex B (informative) Correspondence


    between ISO 13485:2016 and ISO 9001:
    2015 2 Normative references

    Annex A (informative) Comparison of 3 Terms and definitions


    content between ISO 13485:2003 and
    ISO 13485:2016
    4.1. General requirements

    4. Quality management system 4.2. Documentation requirements


    8.1. General

    8.2 Monitoring and measurement

    8.3 Control of nonconforming product


    ISO 13485:2016 5.1. Management commitment
    8. Measurement, analysis and
    improvement 5.2. Customer focus
    8.4. Analysis of data
    5.3. Quality policy
    8.5. Improvement
    5. Management responsibility 5.4. Planning

    5.5. Responsibility, authority and communication


    7.1 Planning of product realization

    5.6. Management review


    7.2. Customer-related processes

    7.3 Design and development


    6.1. Provision of resources
    7.4. Purchasing 7. Product realization
    6.2. Human resources
    7.5. Production and service provision
    6. Resource management 6.3. Infrastructure
    7.6 Control of monitoring and measuring equipment
    6.4 Work environment and contamination control

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