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91.—(1) The manufacturer shall—
(a)allow the approved body access to the manufacture, inspection, testing and storage sites for assessment;
(b)provide the quality system documentation;
(c)provide the quality records provided for by the design part of the quality system, such as results of analyses, calculations, tests and any other relevant quality records;
(d)provide the quality records provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, and any other relevant quality records; and
(e)provide any other information deemed necessary by the approved body.
(2) The approved body shall—
(a)carry our periodic audits to make sure that the manufacturer maintains and applies the quality system;
(b)provide the manufacturer with an audit report;
(c)ensure that the frequency of the periodic audits is such that a full reassessment is carried out every three years.
(3) The approved body may pay unexpected visits to the manufacturer. The need for such additional visits, and their frequency, should be determined on the basis of a visit control system operated by the approved body. The following factors shall be considered in the visit control system—
(a)the category of the pressure equipment or assembly;
(b)the results of previous surveillance visits;
(c)the need to follow up corrective actions;
(d)special conditions linked to the approval of the system, where applicable; and
(e)significant changes in manufacturing organisation, policies or techniques.
(4) During unexpected visits the approved body—
(a)may carry out product tests or have them carried out, where necessary, in order to verify that the quality system is functioning correctly;
(b)shall provide the manufacturer with a visit report; and
(c)shall, where tests have been carried out, provide the manufacturer with a test report.]
Textual Amendments
F1Sch. 1A inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 24 para. 44 (with Sch. 24 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
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