Codes & Standards - Purchase

CAN/CSA-ISO/TR 14969-05 (R2015)

Medical Devices - Quality Management Systems - Guidance on the Application of ISO 13485:2003 (Adopted ISO/TR 14969:2004, first edition, 2004-10-15)

SKU: 2417349 Published by CSA Group Publication Year 2005 Reaffirmed in 2015 90 pages Withdrawn

Product Details

Preface/Scope

Preface

This is the first edition of CAN/CSA-ISO/TR 14969, Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Report ISO/TR 14969 (first edition, 2004-10-15). At the time of publication, ISO/TR 14969:2004 is available from ISO in English only.

Scope

1.1 General

This Technical Report 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. This Technical Report does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.

Note: The terms should, can and might within this Technical Report are used as follows. Should is used to indicate that, amongst several possibilities to meet a requirement in ISO 13485, one is recommended as being particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required. Can and might are used to indicate possibilities or options. These terms do not indicate requirements. 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.

Request Copyright Permissions

Language

English

Format

PDF

GST REG No R119441681
QST REG No R1006017360

Features	CSA Advantage^TM	CSA OnDemand^TM
Offline access
Full-text search
Create highlights and personal notes
Newest editions added automatically
Includes all supported languages and archive versions
My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference
Toggle between your files and the full standard to maintain context
Instantly preview cross referenced material within the book
Export personal notes to Excel
Transfer notes and highlights when updates are available
Adobe Reader PDF and browser compatible for iOS and Android
Web, Android, iOS Compatible

Browse By Subject Area

Browse By Publisher

ICS Catalogue

Browse By Subject Area

CSA Subscriptions

ICS Catalogue

en

fr

Catalogue

Browse By Subject Area

Browse By Publisher

ICS Catalogue

Subscription

Browse By Subject Area

CSA Subscriptions

ICS Catalogue

Services

en

fr

Codes & Standards - Purchase

CAN/CSA-ISO/TR 14969-05 (R2015)

Product Details

Language

Format

Browse By Subject Area

Browse By Publisher

ICS Catalogue

Browse By Subject Area

CSA Subscriptions

ICS Catalogue

Language

en

fr

Currency

CAD

USD

Catalogue

Browse By Subject Area

Browse By Publisher

ICS Catalogue

Subscription

Browse By Subject Area

CSA Subscriptions

ICS Catalogue

Services

Language

en

fr

Currency

CAD

USD

Search Section

Codes & Standards - Purchase

CAN/CSA-ISO/TR 14969-05 (R2015)

Product Details

Language

Format