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I.S. EN ISO 13485:2016/A11:2021

Current
Current

The latest, up-to-date edition.

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-26-2021

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
Annex A (informative) Comparison of content between ISO 13485:2003 and ISO 13485:2016
Annex B (informative) Correspondence between ISO 13485:2016 and ISO 9001:2015
Bibliography

This International Standard specifies 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.

Committee
ISO/TC 210
DocumentType
Standard
Pages
116
ProductNote
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD IS REFERSTO : GHTF/SG1/N055:2009, GHTF/SG5/N4:2010, GHTF/SG1/N70:2011, GHTF/SG1/N071:2012
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
EN ISO 13485:2016/A11:2021 Identical
ISO 13485:2016 Identical

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Hardcopy - English
PDF - English
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