Summary of assessment
QM-Section
QSR-Section
1.
Management responsibility
Subpart A - ( 820.20 Management responsibility
2.
Quality management (QM)-system
Subpart B - ( 820.5 Quality System
3.
Contract review
4.
Design control
Subpart C - ( 820.30 Design controls
5.
Document and data control
Subpart D - ( 820.40 Document controls
6.
Purchasing
Subpart E - ( 820.50 Purchasing controls
7.
Control of customer-supplied product
8.
Product identification and traceability
Subpart F - ( 820.60 Identification ( 820.65 Traceability
9.
Process control
Subpart G -( 820.70 Production and process controls
( 820.75 Process validation
10.
Inspection and testing
11.
Control of inspection, measuring and test equipment
Subpart G -( 820.72 Inspection, measuring, and test equipment
12.
Inspection and test status
Subpart H - ( 820.80 Receiving, in-process, and finished device acceptance
( 820.88 Acceptance status
13.
Control of nonconforming product
Subpart I - ( 820.90 Nonconforming product
14.
Corrective and preventive action
Subpart J - ( 820.100 Corrective and preventive action
15.
Handling, storage, packaging, preserve. and delivery
Subpart K - ( 820.120 Device labeling
( 820.130 Device packaging
Subpart L - ( 820.140 Handling
( 820.150 Storage
( 820.160 Distribution
( 820.170 Installation
16.
Control of quality records
Subpart M - ( 820.180 General requirements
( 820.181 Device master record
( 820.184 Device history record
( 820.188 Quality system record
( 820.198 Complaint files
17.
Internal quality audits
Subpart A - ( 820.22 Quality audit
18.
Training
Subpart A - ( 820.25 Personnel
19.
Servicing
Subpart N - ( 820.200 Servicing
20.
Statistical techniques
Subpart O - ( 820.250 Statistical techniques
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