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AAMI ISO TIR 14969 : 2004

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
Available format(s)

Hardcopy , PDF

Withdrawn date

01-11-2017

Language(s)

English

Published date

01-01-2004

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO/TR14969:2004
Foreword
Introduction
1 Scope
  1.1 General
  1.2 Application
      1.2.1 General
      1.2.2 Exclusions
      1.2.3 Non-applicability
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
      6.4.1 General
      6.4.2 Environmental control in product realization
      6.4.3 Personnel
      6.4.4 Contaminated or potentially contaminated product
7 Product realization
  7.1 Planning of product realization
      7.1.1 General
      7.1.2 Risk management
      7.1.3 Lifetime of the medical device
  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
      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 information
      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
Annexes
A - Terms used in certain regulatory administrations to
    describe documents referenced in this Technical Report
B - 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.

Committee
WG 01
DevelopmentNote
Supersedes AAMI ISO 14969 (12/2004)
DocumentType
Standard
Pages
91
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Withdrawn
Supersedes

Standards Relationship
ISO 14969:1999 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

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