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procedures and responsibilities of a total quality assurance program with the ultimate goal being to provide our valued customers with a precision part or 4-1985, USFDA GMP, Health Canada,. European Medical Device Directive 93/42/EEC and EN 46001. The Management fully endorses the Quality Assurance program as The Quality Control Manager is authorized to prepare, implement, and maintain the Quality. Assurance Program described in this manual. Company Background.The Quality Assurance Manual will help your firm comply with the specific requirements of the quality control standards, as well as develop and document 5.1 The President in conjunction with the Quality Assurance Manager and other department supervisors, as applicable, shall define and document the quality plan The Quality Assurance Manual is a living document that contains Fermilab's policies and procedures designed to manage quality in accordance with the