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  • 03/314215 DC : DRAFT OCT 2003

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003

    Available format(s): 

    Superseded date:  03-11-2004

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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

    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
           1.2.1 General
           1.2.2 Exclusions
           1.2.3 Non-applicability
           1.2.4 Example
    2 Normative references
    3 Terms and definitions
    4 Quality management system
       4.1 General requirements
       4.2 Documentation requirements
           4.2.1 General
           4.2.2 Quality manual
           4.2.3 Control of documents
           4.2.4 Control of records
    5 Management responsibility
       5.1 Management commitment
       5.2 Customer focus
       5.3 Quality policy
       5.4 Planning
           5.4.1 Quality objectives
           5.4.2 Quality management system planning
       5.5 Responsibility, authority, and communication
           5.5.1 Responsibility and authority
           5.5.2 Management representative
           5.5.3 Internal communication
       5.6 Management review
           5.6.1 General
           5.6.2 Review input
           5.6.3 Review output
    6 Resource management
       6.1 Provision of resources
       6.2 Human resources
           6.2.1 General
           6.2.2 Competence, awareness and training
       6.3 Infrastructure
       6.4 Work environment
    7 Product realization
       7.1 Planning of product realization
       7.2 Customer-related processes
           7.2.1 Determination of requirements related to the product
           7.2.2 Review of requirements related to the product
           7.2.3 Customer communication
       7.3 Design and development planning
           7.3.1 Design and development planning
           7.3.2 Design and development inputs
           7.3.3 Design and development outputs
           7.3.4 Design and development review
           7.3.5 Design and development verification
           7.3.6 Design and development validation
           7.3.7 Control of design and development changes
       7.4 Purchasing
           7.4.1 Purchasing process
           7.4.2 Purchasing process
           7.4.3 Verification of purchased product
       7.5 Production and service provision
           7.5.1 Control of production and service provision
           7.5.2 Validation of processes for production and
                 service provision
           7.5.3 Identification and traceability
           7.5.4 Customer property
           7.5.5 Preservation of product
       7.6 Control of monitoring and measuring devices
    8 Measurement, analysis and improvement
       8.1 General
       8.2 Monitoring and measurement
           8.2.1 Feedback
           8.2.2 Internal audit
           8.2.3 Monitoring and measurement of processes
           8.2.4 Monitoring and measurement of product
       8.3 Control of nonconforming product
       8.4 Analysis of data
       8.5 Improvement
           8.5.1 General
           8.5.2 Corrective action
           8.5.3 Preventive action
    Annex A (informative) Terms used in certain regulatory
            administrations to describe documents referenced
            in this Technical Report
    Bibliography

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

    Comment Closes On
    Committee CH/210/1
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 19011:2011 Guidelines for auditing management systems
    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 10013:1995 Guidelines for developing quality manuals
    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/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 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
    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 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
    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 9000-3:1997 Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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