PD CEN ISO/TR 14969:2005 - Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 – BSI British Standards

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PD CEN ISO/TR 14969:2005

Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003

Status : Withdrawn   Published : November 2004

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Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003

Executive summary

Guidance on the development, implementation and maintenance of quality management systems for medical devices (ISO 13485:2003).

Abstract

This International Standard Technical Report provides guidance to assist in the development, implementation and maintenance of quality management systems that aim to meet the requirements of ISO 13485 for organizations that design and develop, produce, install and service medical devices, or that design, develop and provide related services. It provides guidance related to quality management systems for a wide variety of medical devices and related services, such as active, non-active, implantable and non-implantable medical devices and in vitro diagnostic medical devices. It does not add to, or otherwise change, the requirements of ISO 13485.

This report 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 the variety of methods and approaches available for meeting the requirements of ISO 13485.

The guidance contained in this report can be useful as background information for those representing quality management system assessors, conformity assessment bodies and regulatory enforcement bodies.

History and related standards

This International Standard includes the following cross-reference:

ISO 9000:2000.




Standard NumberPD CEN ISO/TR 14969:2005
TitleMedical devices. Quality management systems. Guidance on the application of ISO 13485:2003
StatusWithdrawn
Publication Date03 November 2004
Withdrawn Date01 June 2016
Cross ReferencesISO 9000:2000, ISO 13485:2003, ISO 9001:2000, ISO 9004:2000, ISO 10005:1995, ISO 10007:2003, ISO 10012:2003, ISO/TR 10013:2001, ISO/TR 10017:2003, ISO 11134:1994, ISO 11135:1994, ISO 11137:1995, ISO 11607:2003, ISO 11737-1:1995, ISO 12891-1:1998, ISO 13408-1:1998, ISO/TS 13409:2002, ISO 13683:1997, ISO 14155-1:2003, ISO 14160:1998, ISO 14644-1:1999, ISO 14644-2:2000, ISO 14644-3, ISO 14644-4:2001, ISO 14644-5:2004, ISO 14644-6, ISO 14644-7:2004, ISO 14644-8, ISO 14937:2000, ISO 14971:2000, ISO 15223:2000, ISO/TR 16142:1999, ISO 19011:2002, EN 724:1994, EN 928:1995, EN 980:2003, EN 50103:1995, ISO 11607:2001
International RelationshipsCEN ISO/TR 14969:2005,ISO/TR 14969:2004
Amended ByAMD 15958
Draft Superseded By03/314215 DC
DescriptorsMedical equipment, Medical instruments, Medical technology, Quality assurance systems, Quality assurance, Quality management, Quality, Design, Installation, Maintenance, Production management, Acceptance (approval)
ICS03.100.70
03.120.10
11.040.01
Title in FrenchDispositifs medicaux. Systemes de gestion de qualite. Lignes directrices pour l'application de l'ISO 13485:2003
CommitteeCH/210/1
ISBN0 580 44699 9
PublisherBSI
FormatA4
DeliveryNo
Pages88
File Size2.307 MB
NotesThis standard is withdrawn. This standard is a guidance document, used to implement BS EN ISO 13485 which was recently revised to the latest 2016 version.
Price£244.00


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