02/560598 DC : DRAFT FEB 2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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ISO/DIS 13485 - QUALITY SYSTEMS - MEDICAL DEVICES - SYSTEM REQUIREMENTS FOR REGULATORY PURPOSES
23-11-2012
24-07-2003
0 Introduction
0.1 General
0.2 Process approach
0.3 Relationship with other standards
0.4 Compatibility with other management systems
1 Scope
1.1 General
1.2 Application
2 Normative reference
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
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 realizations
7.2 Customer focus
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
Annex B
Bibliography
| Committee |
CH/66
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 10011-3:1991 | Guidelines for auditing quality systems — Part 3: Management of audit programmes |
| 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 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 10011-1:1990 | Guidelines for auditing quality systems — Part 1: Auditing |
| ISO 10012-2:1997 | Quality assurance for measuring equipment — Part 2: Guidelines for control of measurement processes |
| 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 |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| 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 10012-1:1992 | Quality assurance requirements for measuring equipment — Part 1: Metrological confirmation system for measuring equipment |
| ISO 13683:1997 | Sterilization of health care products — Requirements for validation and routine control of moist heat sterilization in health care facilities |
| ISO 10011-2:1991 | Guidelines for auditing quality systems — Part 2: Qualification criteria for quality systems auditors |