4.2. The manufacturer must allow the [F1approved] body entrance for inspection purposes to the locations of design, manufacture, inspection and testing, and storage and must provide it with all necessary information, in particular:E+W+S
— the quality assurance system documentation
— the quality records as foreseen by the design part of the quality assurance system, such as results of analyses, calculations, tests, etc.
— the quality records as foreseen by the manufacturing part of the quality assurance system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned etc.
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F1Word in Sch. 11 para. 4 substituted (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. 8 para. 24(f) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
4.2. The manufacturer must allow the notified body entrance for inspection purposes to the locations of design, manufacture, inspection and testing, and storage and must provide it with all necessary information, in particular:N.I.
— the quality assurance system documentation
— the quality records as foreseen by the design part of the quality assurance system, such as results of analyses, calculations, tests, etc.
— the quality records as foreseen by the manufacturing part of the quality assurance system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned etc.
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only