API Q1 9th Edition Mandatory Records

No. Clause No. Description

1 4.3.2.3 Training and Awareness
2 4.4 Documentation Requirements
3 4.4.1 General
4 4.5 Control of Records
5 5.1.2 Determination of Requirements
6 5.1.3 Review of Requirements
7 5.2 Planning
8 5.3 Risk Assessment & management
9 5.4.2 Design and Development Inputs
10 5.4.3 Design and Development Outputs
11 5.4.4 Design and Development Review
12 5.4.5 Design and Development Verification and Final Review
13 5.4.6 Design and Development Validation and Approval
14 5.4.7 Design and Development Changes
15 5.6.1.5 Supplier Evaluation—Records
16 5.6.1.6 Outsourcing
17 5.6.3 Verification Of Purchased Products or activities
18 5.7.1.4 Product Realization capability Documentation
19 5.7.1.5 Validation of Process for Production & Servicing
20 5.7.2 Product Quality Plans
21 5.7.3 Identification & traceability
22 5.7.5 Customer-supplied Property
23 5.7.6.2 Storage and Assessment
24 5.7.7.1 Inspection & Testing - General
25 5.7.8 Preventive Maintenance
26 5.8 Control of Testing, Measuring & Monitoring Equipment
27 5.9 Product Release
28 5.10.4 Customer Notification
29 5.10.5 Records
30 5.11.1 General
31 6.2.1 Customer Satisfaction
32 6.2.2.2 Performance of Internal Audit
33 6.2.2.3 Audit Review and Closure
34 6.4.2 Corrective Action
35 6.4.3 Preventive Action
36 6.5.3 Output Requirements