• There are no items in your cart

I.S. EN ISO 13488:2000

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

08-27-2003

Language(s)

English

Published date

01-01-2000

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.

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

Describes, in conjunction with ISO 9002, the quality system requirements for the production and, when relevant, installation and servicing of medical devices.

DevelopmentNote
Supersedes I.S. EN 46002. (11/2016)
DocumentType
Standard
Pages
36
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

View more information
US$40.56
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.