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I.S. EN ISO 13485:2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
Available format(s)

Hardcopy , PDF

Superseded date

08-06-2019

Language(s)

English

Published date

01-01-2016

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.

National foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management responsibility
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
Annex ZA (informative) - Relationship between this
         European Standard and the Conformity Assessment
         Requirements of EU Directive 90/385/EEC (as amended)
Annex ZB (informative) - Relationship between this
         European Standard and the Conformity Assessment
         Requirements of EU Directive 93/42/EEC (as amended)
Annex ZC (informative) - Relationship between this
         European Standard and the Conformity Assessment
         Requirements of EU Directive 98/79/EC

Provides 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
TC 210
DevelopmentNote
Supersedes I.S. EN 46001 (10/2003) Supersedes I.S. EN ISO 13488. (11/2003) Supersedes I.S. EN 46003. (07/2007) 2016 Edition Incorporates Corrigendum. (03/2016) Supersedes I.S. CEN ISO/TR 14969. (02/2017)
DocumentType
Standard
Pages
82
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

ISO 19011:2011 Guidelines for auditing management systems
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 9001:2015 Quality management systems — Requirements
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)

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