21 CFR 820 - 820.186 Quality system record
Original text
Expert opinion
Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including, but not limited to, the records required by 820.20. Each manufacturer shall ensure that the QSR is prepared and approved in accordance with 820.40.
Any general procedures, not refering to a product, must be summarized in a quality system record (QSR). The best practice here is to list all procedures and templates in an hierarchical structure and show the linkage between them. Any change of procedures, but not their content, will update the QSR.
