Documentation Requirements

4.4.2 Procedures
Verify that procedures required by the standard are established, documented, implemented, and maintained for continual suitability.
(Please complete the Identification of QMS Procedures table.)

Clause

Requirement

Procedure ID:

4.3.2.1
4.4.3
4.4.4
4.5
5.1.1

5.4.1

Competency and Training
Control of Documents
Use of External Documents
Control of Records
Review of Requirements
Risk Assessment &
Management
Design & Development

5.5

Contingency Planning

5.6

Purchasing

SOP 11 competence, training & awareness
SOP 6 Documents Control
SOP 6 Documents Control
SOP 8 Records Management
SOP 1 Customer order & contract review
SOP 3 Risk Assessment & Contingency
Planning
SOP 23 Product Design & Development
SOP 3 Risk Assessment & Contingency
Planning
SOP 4 Suppliers control & Outsourcing

5.3

5.7.5
5.7.6

Verification of Purchased
Products or Activities
Control of Production
Control of Servicing
Validation of Processes for
Production and Validation
Identification & Traceability
Product Inspection/Test
status
Customer-supplied Property
Preservation of Product

5.7.7

Inspection & Testing

5.7.8

Preventive Maintenance
Control of Testing,
Measuring, & Monitoring
Equipment

5.6.3
5.7.1.1
5.7.1.2
5.7.1.5
5.7.3
5.7.4

5.8
5.9

Product Release

6.2.1
6.2.2

Control of Nonconforming
Product
Customer Satisfaction
Internal Audit

6.3

Analysis of Data

6.4.2
6.4.3

Corrective Action
Preventive Action
Monogram Marking (if
applicable)

5.10

Annex A

SOP 5 Purchasing control

Revisio
n
1
1
1
1
1
1
1
1
1

SOP 5 Purchasing control

1

SOP 5 Production Control
SOP 28 Valve Servicing

1
0

SOP 27 Validation of Processes

0

SOP 21 Product Identification & Traceability
SOP 17 Inspection & testing / product
release
SOP 9 Customer property
SOP 20 Product Preservation
SOP 17 Inspection & testing / product
release
SOP 16 Facility Maintenance

0

SOP 19 Testing, measuring & monitoring
equipment
SOP 17 Inspection & testing / product
release
SOP 14 Non-conforming product &
concession
SOP 22 Customer complaint & satisfaction
SOP Internal Audit
SOP 12 Data analysis & process
measurement
SOP 13 Corrective & Preventive Action
SOP 13 Corrective & Preventive Action
SOP 7 Application & Removal of API
Monogram

1
1
0
1
1
1
1
0
1
1
1
0
0
1

Finding