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BS EN 46003:1999

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003

Available format(s)

Hardcopy , PDF

Superseded date

01-31-2008

Language(s)

English

Published date

10-15-1999

US$156.28
Excluding Tax where applicable

Foreword
      Introduction
1 Scope
2 Normative references
3 Definitions
4 Quality system requirements
      4.1 Management responsibility
      4.2 Quality system
      4.3 Contract review
      4.4 Design control
      4.5 Document and data control
      4.6 Purchasing
      4.7 Control of customer-supplied product
      4.8 Product identification and traceability
      4.9 Process control
      4.10 Inspection and testing
      4.11 Control of inspection, measuring and test equipment
      4.12 Inspection and test status
      4.13 Control of nonconforming product
      4.14 Corrective action
      4.15 Handling, storage, packaging, preservation and delivery
      4.16 Control of quality records
      4.17 Internal quality audits
      4.18 Training
      4.19 Servicing
      4.20 Statistical techniques
Annex A (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard addressing
                       essential requirements or other provisions of
                       EU Directives

Defines, in conjunction with EN ISO 9003:1994, the quality system requirements for the final inspection and test of medical devices excluding in vitro diagnostic medical devices and active implantable medical devices, and is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements.

Committee
CH/210/1
DevelopmentNote
Supersedes 96/561178 DC. (09/2005)
DocumentType
Standard
Pages
10
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
NEN EN 46003 : 1999 Identical
DIN EN 46003:1999-10 Identical
NS EN 46003 : 1ED 1999 Identical
NBN EN 46003 : 1ED 2000 Identical
SN EN 46003 : 1999 Identical
UNE-EN 46003:2000 Identical
NF EN 46003 : 1999 Identical
I.S. EN 46003:2000 Identical
EN 46003 : 1999 Identical

EN 29002 : 1994 QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN PRODUCTION & INSTALLATION
EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
EN 724 : 1994 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
ISO 8402:1994 Quality management and quality assurance — Vocabulary
EN ISO 9003:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR FINAL INSPECTION AND TEST
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
EN 50103 : 1995 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY
EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
ISO 9003:1994 Quality systems Model for quality assurance in final inspection and test
EN ISO 8402 : 1995 QUALITY MANAGEMENT AND QUALITY ASSURANCE - VOCABULARY
EN 29001 : 1994 QUALITY SYSTEMS - MODEL FOR QUALITY ASSURANCE IN DESIGN/DEVELOPMENT, PRODUCTION, INSTALLATION & SERVICING
EN 46003 : 1999 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9003

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