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

CSA Group
Standards Development Organisation:
Canadian Standards Association (operating as CSA Group)
Working Program:
View the CSA work program
Designation Number:
CAN/CSA-ISO/TR 14969:05 (R2015)
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Withdrawal
ICS code(s):
11.040.01; 03.120.10
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

CAN/CSA-ISO/TR 14969:05 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

Project need:

A new edition of the ISO 13485 standard has been published and ISO/TR 14969 has been withdrawn. Due to these changes CAN/CSA-ISO/TR 14969:05 is no longer needed and should also be withdrawn.

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.