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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
23-11-2012
29-09-2006
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 (11/2004) Renumbered and superseded by BS PD CEN ISO/TR 14969.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Superseded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 |