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CEN ISO/TR 14969:2005

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
Withdrawn date

08-03-2023

Published date

08-06-2005

Publisher

Comite Europeen de Normalisation

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

ISO/TR 14969:2004 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. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. 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.

Committee
CEN/CLC/JTC 3
DocumentType
Technical Report
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn
SupersededBy

CEN/TR 12401:2009 Dentistry - Guidance on the classification of dental devices and accessories
S.R. CEN TR 12401:2009 DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES
PD CEN/TR 12401:2009 Dentistry. Guidance on the classification of dental devices and accessories

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

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