BS EN 100114-6:1997

Committees responsible
National foreword
Foreword
Abbreviations
Introduction
Related Documents
1 Definitions
2 General Procedures
    2.1 Eligibility for Technology approval
          2.1.1 Relationship between Organization
                 Approval and Technology Approval
          2.1.2 Extension of Organization Approval
          2.1.3 Control Site
    2.2 Application for Technology Approval
3 Management Responsibility
    3.1 Management Commitment
    3.2 Operational Infrastructure
          3.2.1 Management structure
          3.2.2 Additional responsibilities of the CECC
                 System Manager (CSM)
          3.2.3 Technical decision-making
4 Technology Approval Requirements
    4.1 Technology Approval Declaration Document (TADD)
    4.2 Requirements for a TADD
          4.2.1 Management commitment to quality
          4.2.2 Overall quality plan
          4.2.3 Description of technology and processes
          4.2.4 Definitions of the relevant sites and
                 operations
          4.2.5 Process capability plan
          4.2.6 Test vehicles
          4.2.7 Internal audit plan
          4.2.8 Demonstration plan
          4.2.9 Management of non-conforming products
                 or activities
          4.2.10 New product introduction programme
          4.2.11 Interrelationship with subcontractors
          4.2.12 Company definitions and symbols
          4.2.13 List of components covered by
                 Technology Approval
    4.3 Use of specialist contractors and subcontracting
    4.4 Incorporated components
5 Verification
    5.1 Verification of process in accordance with the
          TADD
    5.2 Process capability demonstration
          5.2.1 Administration
          5.2.2 Design
          5.2.3 Manufacturing
    5.3 Control of internal and external interfaces
    5.4 Demonstration programme
6 Product Documentation
    6.1 Contractual Specifications
          6.1.1 Registered CECC Detail Specification
          6.1.2 Customer Detail Specification (CDS)
          6.1.3 Manufacturers product data
    6.2 Register of CECC Detail Specifications
    6.3 Registration of Approval
          6.3.1 Abstract of Technology Approval
          6.3.2 Registration of qualified components
7 Procedure for Technology Approval
    7.1 Submission of TADD
    7.2 Acquisition of Results
    7.3 Internal Audits
    7.4 Statement of Readiness
    7.5 ONS Validation Audits
          7.5.1 Validation of TADD implementation
          7.5.2 Examination of internal audit data
          7.5.3 Proposal for issue of TA validation
    7.6 Execution of the demonstration programme
    7.7 Assessment and Certification
          7.7.1 Examination of initial demonstration data
          7.7.2 Proposal for issue of TA certification
          7.7.3 Granting of Technology Approval
          7.7.4 Technology Approval Certificate
    7.8 Release of certified products
          7.8.1 Attestation of Conformity
          7.8.2 Release prior to the issue of an
                 approval certificate
    7.9 Maintenance of Approval
          7.9.1 Manufacturer's documentation
          7.9.2 Manufacturer/ONS periodic review
          7.9.3 Redeclaration of Conformance
    7.10 Change control procedure
          7.10.1 Changes to the overall quality plan
          7.10.2 Changes to design/manufacturing
                 information
    7.11 Withdrawal of Technology Approval
Annex A Application for Technology Approval
Annex B CECC Audit Statement of Readiness Company
          Declaration
Annex C Definitions
Annex D Form and Content of a TADD
Annex E Technology approval report
Diagram 1 Initial Technology approval
Diagram 2 Changes to Technology Approval

Provides a method of approving a complete technological process covering the qualification aspects common to all products as determined by the technology under consideration. This method meets the needs of users and manufacturers in the management of quality (TQM).