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3. The matters referred to in paragraph 2(c)(ii) are that the quality system documentation contain an adequate description of—
(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
(b)the manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
(c)the examinations and tests that will be carried out before, during and after manufacture and the frequency with which they will be carried out;
(d)the quality records, including inspection reports and test data, calibration data and qualification reports of the personnel concerned; and
(e)the means to monitor the achievement of the required product quality and the effective operation of the quality system.
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