F1SCHEDULE 17CONFORMITY ASSESSMENT PROCEDURES
Annotations:
Amendments (Textual)
PART 3CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS (MODULE D)
21
1
A manufacturer must—
a
fulfil the obligations arising out of the quality system as approved and maintain it in an adequate and efficient state; and
b
keep the approved body that has approved the quality system informed of any intended change to the quality system.
2
Where the approved body is notified by a manufacturer of any proposed change to the quality system the approved body must—
a
evaluate such proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 19 or whether a reassessment is necessary; and
b
notify the manufacturer of its decision and, that notification must contain the conclusions of the examination and a reasoned assessment of the decision.
Schs. 17, 18 inserted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 16 para. 35 (with Sch. 16 para. 29) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)