Abstract: . . .  quality system Page 1 141 Food and Drug Administration, HHS § 820.20 (n) Management with executive respon- sibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer’s quality policy and quality system . (o) Manufacturer means . . .
. . .  shall be made aware of device defects which may occur from the im- proper performance of their specific jobs. (2) Personnel who perform verification and validation activities shall be made aware of defects and er- rors that may be encountered as part of their job functions. Subpart C—Design Controls §820.30 Design controls. (a) General. (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the de- sign of the device in order . . .
. . .  appropriate. §820.22 Quality audit. Each manufacturer shall establish procedures for quality audits and con- duct such audits to assure that the quality system is in compliance with the established quality system require- ments and to determine the effective- ness of the quality system . Quality au- dits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Correc- tive action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, . . .
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