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  • BS PD ISO/TR 14969 : 2004 AMD 15958

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003

    Available format(s): 

    Superseded date:  29-09-2006

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

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

    General Product Information - (Show below) - (Hide below)

    Committee CH/210/1
    Development Note Supersedes 03/314215 DC. (11/2004) Renumbered and superseded by BS PD CEN ISO/TR 14969. (09/2006)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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