I.S. EN 46001:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 9001
Hardcopy , PDF
08-29-2003
English
01-01-1997
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.
Foreword
0 Introduction
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 inspection, measuring and test equipment
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
Annex A (informative) - Bibliography
Important note : All end users must be registered with an Account prior to user licenses being assigned.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.