Quality Procedures and Work Instructions Manual

Quality Procedures and Work Instructions Manual

Revision Number: (1)

ISSUED TO: ____________________________________ MANUAL NO: __________________________________ REVISION NO: _________________________________ ISSUE DATE: ___________________________________

_______________________ President

___________ Date

1

Quality Procedures and Work Instructions Manual

Section ii. Table of Contents

Page

Date

Revision

1 of 4

0

Section Number Name

Revision

i.

Title Page

ii.

Table of Contents

1.0.

Management Review

2.0

The Quality System

3.0.

Contract Review

5.0.

Document and Data Control

5.1 Document Preparation and Issue 5.2 Writing a Quality System Document

6.0.

Purchasing

6.1 Approved Supplier Selection 6.2 Purchase Requisition Expenditure Authorization 6.3 Routine Purchase Request 6.4 Urgent Purchase Request 6.5 Standing Order Purchase 6.6 Petty Cash Purchase 6.7 Purchase Requisition Form Completion 6.8 Outstanding Order Progress 6.9 Using a Courier 6.10 Outside Work

Date

2

Quality Procedures and Work Instructions Manual

Section ii. Table of Contents

Page

Date

Revision

2 of 4

0

Section Number

7.0. 8.0. 9.0.

10.0.

Name

Revision

Control of Customer-Supplied Product

Product Identification and Traceability

Process Control

9.1 Special Processes 9.2 Emergency Call 9.3 Inspection 9.4 Risk Assessment of Patient Care Devices 9.5 Selecting Inspection and Preventive Maintenance Items 9.6 Inspection and Preventive Maintenance Scheduling 9.7 Transferring Equipment 9.8 Using the Equipment Management Software 9.9 Training Record Creation 9.10 Training Work Order Creation 9.11 Resource Allocation 9.12 Purchasing Advice 9.13 Equipment Evaluation 9.14 Soldering

Inspection and Testing

10.1 Incoming Goods Inspection

3

Date

Quality Procedures and Work Instructions Manual

Section ii. Table of Contents

Page

Date

Revision

3 of 4

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11.0. 12.0.

13.0. 14.0. 15.0.

Control of Inspection, Measuring, and Test Equipment

Inspection and Test Status

12.1 Equipment Status Tag Completion 12.2 Incoming Work 12.3 Work Dispatch

Control of Nonconforming Product

13.1 Customer Complaints

Corrective and Preventive Action

14.1 Performance Reports

Handling, Storage, Packaging, Preservation, and Delivery

15.1 Stock Issue 15.2 Stock Control 15.3 Handling and Storage of Static-Sensitive Devices (SSDs) 15.4 Handling of Mercury 15.5 Handling of Contaminated Equipment

4

Quality Procedures and Work Instructions Manual

Section ii. Table of Contents

Page

Date

Revision

4 of 4

0

16.0.

17.0 18.0. 19.0. 20.0

Control of Quality Records

16.1 Computer Backup 16.2 Filing of Work Records 16.3 Medical Equipment Service Report Completion 16.4 Medical equipment Service Report and Equipment File Checking 16.5 Equipment File Completion 16.6 Part Record Creation 16.7 Project File Input 16.8 Work Order Completion 16.9 Project Work Order Input

Internal Quality Audits

17.1 Quality Assurance Program

17.2 Quality Assurance Indicators for Patient Care Devices

Training

Servicing

19.1 Maintenance of Medical Devices

19.2 Service Standards

Statistical Techniques

5

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