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SN EN ISO 13488 : 2001

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
Superseded date

09-01-2003

Published date

01-12-2013

Contents
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 nonconforming product
    4.12 Inspection and test status
    4.13 Control of nonconforming product
    4.14 Corrective and preventive 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

Specifies in conjunction with ISO 9002, the quality system requirements for the production, installation and servicing of medical devices when relevant. It applies when there is a need to assess a medical device supplier's quality system.

DocumentType
Standard
PublisherName
Swiss Standards
Status
Superseded

Standards Relationship
BS EN ISO 13488:2001 Identical
UNE-EN ISO 13488:2001 Identical
ISO 13488:1996 Identical
EN ISO 13488 : 2000 Identical
DIN EN ISO 13488:2001-02 Identical
I.S. EN ISO 13488:2000 Identical

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