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Euro Assessments is a leading global independent certification and auditing organization that delivers assurance and inspires confidence in customers with standards-based solutions.

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

Before ISO 13485:1996
ISO 9001:1994 – (Medical Devices Under ISO 9000 Series)

  • Year: 1994
  • General quality system controls
  • Production & installation
  • Documented procedures
  • Basic regulatory expectations

EN 46001 & EN 46002 (European Medical Device Quality Standards)

  • EN 46001
  • EN 46002)
Version Year Key Focus
1993–1994 EN 46001 / EN 46002 Early European medical QMS standards
1996 ISO 13485:1996 First dedicated medical device QMS standard
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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