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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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