The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General Requirements - Supplement No. 4 - Compilation of Audit Documentation (Clause 5.7)
This document has been written to provide assistance in the application of the 'Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General
requirements’ and should be read in conjunction with that document.