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

Find Similar Items

This product falls into the following categories.

You may find similar items within these categories by selecting from the choices below:

Result Types

Subject

Industry Sector

Committee

ICS Category

PD CEN ISO/TR 14969:2005

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

Status : Current   Published : November 2004

Price
£ 210.00
Member Price
£ 105.00
Become a member and SAVE 50%
on British Standards. Click to learn more
Format
PDF

Format
HARDCOPY

Giving you support and advice in the implementation of a quality management system for medical devices

This Technical Report provides guidance for the application of BS EN ISO 13485. It can be used to better understand the requirements of BS EN ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting best practice guidelines.

The guidance is applicable to the design, development, production, installation and servicing of medical devices of all kinds.

The principles and examples contained in PD CEN ISO/TR 14969:2005 can be useful as background information for those representing quality management system assessors, Conformity Assessment Bodies and regulator enforcement bodies.

Model of a process-based quality management system

 




Standard NumberPD CEN ISO/TR 14969:2005
TitleMedical devices. Quality management systems. Guidance on the application of ISO 13485:2003
StatusCurrent
Publication Date03 November 2004
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 Identical, ISO/TR 14969:2004 Identical
Amended ByAMD 15958
Supersedes Draft03/314215 DC
DescriptorsMedical equipment, Medical instruments, Medical technology, Quality assurance systems, Quality assurance, Quality management, Quality, Design, Installation, Maintenance, Production management, Acceptance (approval)
ICS03.120.10 (Quality management and quality assurance)
11.040.01 (Medical equipment in general)
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
DeliveryYES
Pages88
File Size2.322 MB
Price£ 210.00


Your basket
Your basket is empty

Help!

Need some assistance?


Success story

Mercedes GP Petronas Formula One team use standards to win


Sell BSI books

Become a BSI Affiliate and sell our books on your website


In the making

BSI Standards Development:
Know what's coming

Customers who bought this product also bought

  • BS EN 1041:2008
    Information supplied by the manufacturer of medical devices
  • BS EN ISO 17665-1:2006
    Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
  • BS EN ISO 10993-18:2009
    Biological evaluation of medical devices. Chemical characterization of materials
  • BS EN ISO 14644-5:2004
    Cleanrooms and associated controlled environments. Operations