AAMI ISO TIR 14969 : 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.