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(See Related Information)Preamble References

Section Preamble Pages
820.1 Scope 52605-52607 #1-13
820.3 Definitions 52607-52612 #14-43
  Establish 52609 #24
  Finished Device 52609 #25
  Manufacturer 52609-52610 #28
  Product 52610 #31
  Quality 52611 #32
  Remanufacturer 52611 #38, also 52609-52610 #28
820.20 Management Responsibility 52612-52614 #45-54
  Management with executive responsibility definition 52609 #27
  Quality Policy definition 52611 #34
  Specification definition 52612 #42
820.22 Quality Audit 52614-52615 #55-58
  Quality Audit definition 52611 #33
820.25 Personnel 52615 #59-61
 
820.30 Design Controls 52615-52622 #62-92
  Design Input definition 52608 #19
  Design Output definition 52608 #20
  Design Review definition 52608 #21
  Validation definition 52612 #43
  Design Validation definition 52612 #43
  Verification definition 52612 #43
  Design History File definition 52608 #18
820.40 Documents and Records 52622 #93-97
  Record 52611 #36
820.50 Purchasing Controls 52623-52626 #98-116
820.60 Identification 52626-52627 #117-119
820.65 Traceability 52627 #120-121
  Component definition 52608 #15
  Control Number definition 52608 #16
820.70 Production & Process Controls 52627-52630 #122-136
  Manufacturing Material definition 52610 #29
820.72 Inspection, Measuring & Test Equipment 52630 #137-142
820.75 Process Validation 52631 #143-145
  Validation definition 52612 #43
  Process Validation definition 52612 #43
  Verification definition 52612 #43
820.86 Acceptance Status 52632 #152-153
820.80 Receiving, In-Process & Finished Device Acceptance 52631-52632 #146-151
820.90 Nonconforming Product 52632-52633 #154-157
  Nonconformity definition 52610 #30
  Rework definition 52611 #39
820.100 Corrective & Preventive Action 52633-52635 #158-166
820.120 Device Labeling 52635 #167-171
820.130 Device Packaging 52635 #172
820.140 Handling 52635-52636 #173
820.150 Storage 52636 #174-175
820.160 Distribution 52636 #176-177
820.170 Installation 52636 #178-179
820.180 Documents and Records, General Requirement 52637 #180-186
820.181 Device Master Record 52637-52638 #183-186
  Device Master Record definition 52609 #22
820.184 Device History Record 52638 #187-188
  Device History Record definition No Preamble discussion
  Lot or Batch definition 52609 #26
  Control Number definition 52608 #16
820.198 Complaint Files 52638-52634 #190-198
  Complaint definition 52607
820.250 Statistical Techniques 52640 #203-204

Updated 3/9/2000

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