Name: BS PD ISO/TR 14969 : 2004 AMD 15958
Brand: BSI

BS PD ISO/TR 14969 : 2004 AMD 15958

Superseded

View Superseded by

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

Superseded date

09-29-2006

Published date

11-23-2012

Publisher

British Standards Institution

Foreword
Introduction
  0.1 General
  0.2 Process approach
  0.3 Relationship with other standards, guidance documents
      and regulatory requirements
  0.4 Compatibility with other management systems
1 Scope
  1.1 General
  1.2 Application
2 Normative references
3 Terms and definitions
4 Quality management system
  4.1 General requirements
  4.2 Documentation requirements
5 Management responsibility
  5.1 Management commitment
  5.2 Customer focus
  5.3 Quality policy
  5.4 Planning
  5.5 Responsibility, authority and communication
  5.6 Management review
6 Resource management
  6.1 Provision of resources
  6.2 Human resources
  6.3 Infrastructure
  6.4 Work environment
7 Product realization
  7.1 Planning of product realization
  7.2 Customer-related processes
  7.3 Design and development
  7.4 Purchasing
  7.5 Production and service provision
  7.6 Control of monitoring and measuring devices
8 Measurement, analysis and improvement
  8.1 General
  8.2 Monitoring and measurement
  8.3 Control of nonconforming product
  8.4 Analysis of data
  8.5 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

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

Committee	CH/210/1
DevelopmentNote	Supersedes 03/314215 DC. (11/2004) Renumbered and superseded by BS PD CEN ISO/TR 14969. (09/2006)
DocumentType	Standard
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	PD CEN ISO/TR 14969:2005
Supersedes	03/314215 DC : DRAFT OCT 2003

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