Name: CSA ISO TR 14969 : 2005 : R2010
Brand: CSA

CSA ISO TR 14969 : 2005 : R2010

Superseded

View Superseded by

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003

Available format(s)

Hardcopy , PDF

Superseded date

17-07-2021

Language(s)

English

Published date

01-01-2015

Publisher

Canadian Standards Association

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
Annex A (informative) - Terms used in certain regulatory
        administrations to describe documents referenced in
        this Technical Report
Annex B (informative) - Analysis of significant changes from
        ISO 13485:1996 to ISO 13485:2003
Bibliography

Gives guidance for the application of the requirements for quality management systems contained in ISO 13485.

DocumentType	Standard
Pages	90
ProductNote	Reconfirmed EN
PublisherName	Canadian Standards Association
Status	Superseded
SupersededBy	CSA ISO TR 14969 : 2005 : R2015
Supersedes	CSA ISO TR 14969 :2005

Standards	Relationship
ISO/TR 14969:2004	Identical

ISO 19011:2011	Guidelines for auditing management systems
ISO 14644-6:2007	Cleanrooms and associated controlled environments Part 6: Vocabulary
ISO 14644-8:2013	Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC)
ISO 14160:2011	Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO/TR 10017:2003	Guidance on statistical techniques for ISO 9001:2000
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 14644-2:2015	Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
ISO 11737-1:2006	Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 14644-5:2004	Cleanrooms and associated controlled environments — Part 5: Operations
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
EN 724 : 1994	GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
ISO 14155-1:2003	Clinical investigation of medical devices for human subjects Part 1: General requirements
ISO 10005:2005	Quality management systems Guidelines for quality plans
ISO/TR 16142:2006	Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO/TS 13409:2002	Sterilization of health care products Radiation sterilization Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
ISO 14644-3:2005	Cleanrooms and associated controlled environments Part 3: Test methods
ISO 9004:2009	Managing for the sustained success of an organization A quality management approach
ISO 13408-1:2008	Aseptic processing of health care products — Part 1: General requirements
ISO/TR 10013:2001	Guidelines for quality management system documentation
ISO 14644-7:2004	Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
EN 50103 : 1995	GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY
ISO 10012:2003	Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 14644-1:2015	Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
ISO 9001:2015	Quality management systems — Requirements
EN 928 : 1995	IN VITRO DIAGNOSTIC SYSTEMS - GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES
ISO 11607:2003	Packaging for terminally sterilized medical devices
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 14644-4:2001	Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
ISO 11134:1994	Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 11137:1995	Sterilization of health care products Requirements for validation and routine control Radiation sterilization
ISO 10007:2017	Quality management — Guidelines for configuration management
EN 980:2008	Symbols for use in the labelling of medical devices
ISO 13683:1997	Sterilization of health care products Requirements for validation and routine control of moist heat sterilization in health care facilities
ISO 12891-1:2015	Retrieval and analysis of surgical implants Part 1: Retrieval and handling
ISO 15223:2000	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied