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Phone +44 2080895435
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Location 128 City Road, London, EC1V 2NX, United Kingdom.
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Phone +44 2080895435
Email info@euroassessment
Location 128 City Road, London, EC1V 2NX, United Kingdom.
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Revised Standard

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Revised & Updated International Standards Compliance

ISO 13485:1996 (First Edition)

  • Published: 1996
  • Based on ISO 9001:1994
  • Focused on quality system requirements for medical devices
  • Heavy emphasis on documentation
  • Less structured around risk management

ISO 13485:2003 (Second Edition)

  • Published: 2003
  • Aligned with ISO 9001:2000 (process approach)
  • Became widely adopted globally by medical device companies

ISO 13485:2016 (Current Edition)

  • Published: 2016
  • Introduced risk-based thinking across all processes
  • Strong alignment with global regulatory frameworks:
  • Still the active version today

ISO 9001:2015 (Current Major Version)

  • Published in 2015
  • Introduced risk-based thinking
  • High-Level Structure (Annex SL)
  • Better alignment with other ISO standards
Version Year Key Focus
ISO 9001:1987 1987 Documentation & Procedure Control
ISO 9001:1994 1994 Preventive Action & Quality Assurance
ISO 9001:2000 2000 Process Approach (Major Change)

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  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
  • ISO 9001 2015
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Head office:

128 City Road, London, EC1V 2NX, United Kingdom.

P: +1 (009) 544-7818 M: info@euroassessment
Regional office:

128 City Road, London, EC1V 2NX, United Kingdom.

P: +1 (009) 880-1810 M: info@euroassessment
Regional office:

128 City Road, London, EC1V 2NX, United Kingdom.

P: +1 (009) 544-7818 M: info@euroassessments.co.uk

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