• BS EN ISO 13488:2001

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  24-07-2003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

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CH/210/1
    Development Note Supersedes BS EN 46002:1997 (02/2001)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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