History — 561.09

561.09 (1) The holder of a manufacturer certificate shall, in order to ensure that all aspects of the activities carried out under the manufacturer certificate continue to comply with these Regulations, establish and maintain a quality assurance program, independent of the production control system, that (a) is under the sole control of (i) the person appointed under paragraph 561.04(1)(a), or (ii) a person assigned the responsibility for the management of the quality assurance program under subsection 561.04(6); and (b) meets the requirements specified in section 561.09 of Standard 561. (2) The person referred to in paragraph (1)(a) shall ensure that records related to the findings from the quality assurance program are distributed to the appropriate manager for corrective action and follow-up in accordance with the procedures specified in the manual. (3) The person referred to in paragraph (1)(a) shall establish and maintain an audit system that consists of (a) an initial audit, within 12 months after the day on which the manufacturer certificate is issued, that covers all aspects of the manufacturer’s activities; (b) subsequent audits conducted at the intervals set out in the ma…