AAMI ISO TIR 14969 : 2004
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
11-01-2017
English
01-01-2004
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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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