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NEN EN ISO 13485 : 2016 C11 2017

Current
Current

The latest, up-to-date edition.

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
Published date

01-12-2013

Foreword
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 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) Correspondence between ISO 13485: 2003 and
        ISO 13485: 1996
Annex B (informative) Explanation of differences between
        ISO 13485: 2003 and ISO 9001: 2000
Bibliography

Defines requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

DevelopmentNote
Supersedes NEN EN 46001. (07/2002) Supersedes NEN EN ISO 13488. (09/2003) Supersedes NEN EN 46003. (02/2008)
DocumentType
Standard
PublisherName
Netherlands Standards
Status
Current

Standards Relationship
DIN EN ISO 13485:2016-08 Identical
BS EN ISO 13485:2016 Identical
ISO 13485:2016 Identical
I.S. EN ISO 13485:2016 Identical
SN EN ISO 13485:2016 Identical
UNE-EN ISO 13485:2016 Identical
EN ISO 13485:2016/AC:2018 Identical

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