I.S. EN 100114-1:1997
Current
The latest, up-to-date edition.
Hardcopy , PDF
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.
Section I: Organization approval of manufacturers,
distributors and specialist contractors
0 Introduction
1 Scope
2 Normative references
3 Definitions
4 Quality-system requirements
4.2 Quality system
4.3 Contract review
4.4 Design 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 non-conforming product
4.15 Handling, storage, packaging, preservation
and delivery
4.16 Control of quality records
4.19 Servicing
4.20 Statistical techniques
Section II: Organization approval of independent test
laboratories
0 Introduction
1 Object and field of application
2 Definitions
5 Technical competence
5.1 Management and organization
5.4 Working procedure
Annex A: Requirements for organizations' CECC system managers
Annex B: Subcontracting in the CECC system
B.1 Introduction
B.2 Subcontracting to manufacturers or specialist
contractors with CECC approval
B.3 Subcontracting to a remote site which is part of
the same parent organization (EMA)
B.4 Use of unapproved subcontractors
B.5 Sharing of test facilities
Annex C: CECC policy on uncertainty of measurement and inset
limits
C.1 Objective
C.2 Definitions
C.3 Calculation of Measurement Uncertainty
C.4 Policy
C.5 Calculation of Inset and Outset Limits
C.6 Examples
C.7 References (Information only)
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