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02/560598 DC : DRAFT FEB 2002

Superseded

Superseded

View Superseded by

ISO/DIS 13485 - QUALITY SYSTEMS - MEDICAL DEVICES - SYSTEM REQUIREMENTS FOR REGULATORY PURPOSES

Published date

11-23-2012

Superseded date

07-24-2003

Superseded by

BS EN ISO 13485:2016

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Summarise this standard

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Superseded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

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