BS PD ISO/TR 14969 : 2004 AMD 15958
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
29-09-2006
23-11-2012
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
Provides guidance for the application of the requirements for quality management systems contained in ISO 13485.
| Committee |
CH/210/1
|
| DevelopmentNote |
Supersedes 03/314215 DC. (11/2004) Renumbered and superseded by BS PD CEN ISO/TR 14969. (09/2006)
|
| DocumentType |
Standard
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO/TR 14969:2004 | 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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