NEN EN 46002 : 1996
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
KWALITEITSSYSTEMEN - MEDISCHE APPARATUUR - BIJZONDERE EISEN VOOR DE TOEPASING VAN EN 29002
01-12-2000
12-01-2013
Cooperating organizations
National foreword
Foreword
0. Introduction
1. Scope and field of application
2. Normative references
3. Definitions
4. Quality system requirements
4.1 Management responsibility
4.2 Quality system
4.3 Contract review
4.4 Document control
4.5 Purchasing
4.6 Purchaser supplied product
4.7 Product identification and traceability
4.8 Process control
4.9 Inspection and testing
4.10 Inspection, measuring and test equipment
4.11 Inspection and test status
4.12 Control of nonconforming product
4.13 Corrective action
4.14 Handling, storage, packaging and delivery
4.15 Quality records
4.16 Internal quality audits
4.17 Training
4.18 Statistical techniques
Annex A (informative) - Bibliography
National annex NA (informative) Committees responsible
National annex NB (informative) Cross-references
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.