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BS 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002
Available format(s)

Hardcopy , PDF

Superseded date

24-07-2003

Language(s)

English

Published date

15-03-2001

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.

Committee
CH/210/1
DevelopmentNote
Supersedes BS EN 46002:1997 (02/2001)
DocumentType
Standard
Pages
20
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

ISO 8402:1994 Quality management and quality assurance — Vocabulary
ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization

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$294.12
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