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Required Procedures 21 CFR Section


Procedures for MDRs 803.17  
A documented quality program 820.20  
Documentation of Management review of quality system at defined intervals and at sufficient frequency 820.20  
Procedures for audits 820.22  
Records of audits 820.22  
Procedures for identifying training needs 820.25  
Documentation of any necessary personnel training programs 820.25  
Documents relating to design controls including the Design History File 820.30  
Procedures for specification control measures to assure that device, components , and packaging design results in approved specifications 820.40  
Document controls not previously mentioned 820.40  
Document of specification changes 820.40  
Procedure of approval of change of manufacturing process 820.40  
Record of percentage of defective components for each lot and the percentage of lots rejected 820.50  
Purchasing controls not previously mentioned 820.50  
Limitations or allowable tolerances on equipment 820.70  
Records of equipment inspections 820.70  
Procedures and specifications for manufacturing processes 820.70  
Records of maintenance activities 820.70  
Procedures for processing control 820.70  
Documentation of inspections of any required environmental control system 820.70  
Procedures for contamination control 820.70  
Procedures and schedules for maintenance, adjustment, and cleaning of equipment 820.70  
Procedures for use and removal of manufacturing material 820.70  
Record of removal of manufacturing material 820.70  
Procedure for approval of changes to software programs 820.70  
Procedures for acceptance of components 820.80  
Records of acceptance or rejection of components 820.80  
Procedures for finished device inspection and sampling plans 820.80  
Documentation of testing of computer software programs for calibrating, inspecting, and checking measurement equipment 820.84  
Procedures for calibration, inspection, and checking of measurement equipment 820.84  
Procedures and limits for accuracy and precision in calibration of measurement equipment 820.84  
Records documenting traceability of calibration standards 820.84  
Records of calibration, inspection, and checking of measurement equipment 820.84  
Records of calibration of measurement equipment 820.84  
Procedures for reprocessing of devices or components 820.90  
Record (implied) of final inspection of reprocessed device 820.90  
Records of the disposition of obsolete, rejected, or deteriorated components 820.90  
Records of investigation of failure of device or components after release for distribution 820.100  
Procedures for warehouse control and distribution of finished devices Where necessary, system to assure that oldest approved devices are distributed first 820.124  
Record of examination of labeling materials 820.162  
Device Master Record 820.181  
Device History Record 820.184  
Record of critical operations in device history records by responsible individual 820.184  
Records of written and oral complaints 820.198  
Record of complaint investigation or reason no investigation was done 820.198  
Complaints pertaining to injury, death, or any hazard to safety 820.198  
Servicing procedures, records, and record evaluations 820.200  
Statistical techniques: identification of valid techniques, sampling plans, adequacy 820.250