PD CEN ISO/TR 14969:2005
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
English
29-09-2006
01-06-2016
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 policy006
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
Gives guidance for the application of the requirements for quality management systems contained in ISO 13485.
| Committee |
CH/210/1
|
| DevelopmentNote |
Renumbers and supersedes BS PD ISO/TR 14969. 2005 Version incorporates amendment 15958 to BS PD ISO/TR 14969. Supersedes 03/314215 DC. (09/2006) Also available as part of BS KIT 160. (10/2006)
|
| DocumentType |
Standard
|
| Pages |
88
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| CEN ISO/TR 14969:2005 | Identical |
| ISO/TR 14969:2004 | Identical |
| I.S. CEN ISO TR 14969:2005 | Equivalent |
This standard has been withdrawn and is no longer current. No replacement edition is available.
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