Interpretation of Quality System Regulation (QSR)

Decipher/Interpret FDA's QSR This important site gives you (plain English) interpretation of FDA's Quality System Regulation. For more detailed information we recommend you download our 328 page guide, which also includes relevant QSIT references. Search FDA's QSR Interpretation: Advanced Search

	Subpart A -- General Provisions 820.1 Scope. Section ‘a’ 820.1 Scope. Section ‘b’ 820.1 Scope. Section ‘c’ 820.1 Scope. Section ‘d’ 820.1 Scope. Section ‘e’ 820.5 Quality system 820.20 Management responsibility. Section ‘a’ 820.20 Management responsibility. Section ‘b’ 820.22 Quality audit 820.25 Personnel 820.30 Design controls. Section ‘a’ 820.30 Design controls. Section ‘b’ 820.30 Design controls. Section ‘c’ 820.30 Design controls. Section ‘d’ 820.30 Design controls. Section ‘e’ 820.30 Design controls. Section ‘f’ 820.30 Design controls. Section ‘g’ 820.30 Design controls. Section ‘h’ 820.30 Design controls. Section ‘i’ 820.30 Design controls. Section ‘j’ 820.40 Document controls. Section ‘a’ 820.40 Document controls. Section ‘b’ 820.50 Purchasing controls. Section ‘a’ 820.50 Purchasing controls. Section ‘b’ 820.60 Identification 820.65 Traceability 820.70 Production and process controls 820.72 Inspection, measuring, and test equipment 820.75 Process validation 820.86 Acceptance status 820.90 Nonconforming product 820.100 Corrective and preventive action 820.120 Device labeling 820.130 Device packaging 820.140 Handling 820.150 Storage 820.160 Distribution 820.170 Installation 820.180 General requirements 820.181 Device master record 820.186 Quality system record 820.198 Complaint files. Section ‘a’ 820.198 Complaint files. Section ‘b’ 820.200 Servicing 820.250 Statistical techniques

Decipher/Interpret FDA's QSR