Full Description

This document describes a procedure for conducting internal quality systems auditing to ensure compliance with appropriate regulatory agency requirements and industry standards. This SOP also includes methods for management reporting of audit results and for taking corrective action based on audit observations. This SOP adheres to 21CFR 820.22, ISO 9001-1994, Section 4.17, and Medical Device Directive 93/42/EEC.

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Edition: 1 Published: 11/01/2004 Number of Pages: 4