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Abstract: . . .  dates and results of quality audits and reaudits shall be documented. VerDate Apr<18>2002 06:36 Apr 28, 2002 Jkt 197069 PO 00000 Frm 00141 Fmt 8010 Sfmt 8010 Y:\SGML\197069T.XXX pfrm12 PsN: 197069T  . . .
. . .  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 . . .
. . .  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- . . .
--807,3,134,961,4033
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 141 Subpart B—Quality System Requirements.PDF

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