Annex 6 Module H.3.2—Annex 6 Module H.3.2
>Control Description
The quality system shall ensure compliance of the products with the essential requirements set out in Section 1 of Annex I and compliance of the vulnerability handling processes put in place by the manufacturer with the requirements set out in Section 2 of Annex I.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. That quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of:
- the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design, development, product quality and vulnerability handling;
- the technical design and development specifications, including standards, that will be applied and, where the relevant harmonised standards and/or technical specifications will not be applied in full, the means that will be used to ensure that the essential requirements set out in Section 1 of Annex I that apply to the products will be met;
- the procedural specifications, including standards, that will be applied and, where the relevant harmonised standards and/or technical specifications will not be applied in full, the means that will be used to ensure that the essential requirements set out in Section 2 of Annex I that apply to the manufacturer will be met;
- the design and development control, as well as design and development verification techniques, processes and systematic actions that will be used when designing and developing the products pertaining to the product category covered;
- the corresponding production, quality control and quality assurance techniques, processes and systematic actions that will be used;
- the examinations and tests that will be carried out before, during and after production, and the frequency with which they will be carried out;
- the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc;
- the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.
>Cross-Framework Mappings
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