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Abstract: . . . deficient matters, shall be taken when necessary. A report of the results of VerDate 112000 00:15 Apr 20, 2001 Jkt 194069 PO 00000 Frm 00141 Fmt 8010 Sfmt 8010 Y:\SGML\194069T.XXX pfrm01 PsN: 194069T . . . . . . quality system that is appropriate for the specific medical de- vice(s) designed or manufactured, and that meets the requirements of this part. Subpart B— Quality System Requirements § 820.20 Management responsibility. (a) Quality policy. Management with executive responsibility shall . . . . . . 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 . . . --837,3,140,991,4186
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