PD CEN ISO/TR 14969:2005

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

Published:

3 Nov 2004

•

Withdrawn:

1 Jun 2016

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.

Product Details

Descriptors

Quality

Production management

Design

Quality assurance systems

Medical equipment

Medical technology

Acceptance (approval)

Medical instruments

Quality assurance

Quality management

Installation

Maintenance

ICS Codes

03.100.70 Management systems

03.120.10 Quality management and quality assurance

11.040.01 Medical equipment in general

Committee

CH/210/1

International relationships

Identical to:

CEN ISO/TR 14969:2005

ISBN

0 580 44699 9

Publisher

BSI