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SN-CEN ISO/TR 14969:2005

Medical devices — Quality management systems — Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)

standard by Standards Norway SN-CEN ISO/TR Series , 06/01/2005

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Full Description

ADOPTED_FROM:CEN ISO/TR 14969:2005 ISO/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.
 

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Published:
06/01/2005
Number of Pages:
92
 

Document History

  1. NS-EN ISO 13485:2016


    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

    • Most Recent

  2. NS-EN ISO 13485:2012/AC:2012


    Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)

    • Historical Version

  3. NS-EN ISO 13485:2012


    Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

    • Historical Version

  4. NS-EN ISO 13485:2003/AC:2009


    Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)

    • Historical Version

  5. NS-EN ISO 13485:2003/AC:2007


    Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

    • Historical Version

  6. SN-CEN ISO/TR 14969:2005

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    Medical devices — Quality management systems — Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)

    • Historical Version

  7. NS-EN ISO 13485:2003


    Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

    • Historical Version

  8. NS-EN ISO 13485:2000


    Quality systems — Medical devices — Particular requirements for the application of EN ISO 9001 (ISO 13485:1996)

    • Historical Version

  9. NS-EN ISO 13488:2000


    Quality systems — Medical devices — Particular requirements for the application of EN ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996)

    • Historical Version

  10. NS-EN 46003:1999


    Quality systems — Medical devices — Particular requirements for the application of EN ISO 9003

    • Historical Version

  11. NS-EN 46001:1996


    Quality systems — Medical devices — Particular requirements for the application of EN ISO 9001

    • Historical Version

  12. NS-EN 46002:1996


    Quality systems — Medical devices — Particular requirements for the application of EN ISO 9002

    • Historical Version

  13. NS-EN 46001:1993


    Quality systems — Medical devices — Particular requirements for the application of EN 29001

    • Historical Version