chapter  200
60 Pages

20.4: MODEL-4: QUALITY MANUAL ISO 9001:2000

Written by: Checked by: Approved by:

Date Supersedes

mm/dd/yyyy

Date Issued

mm/dd/yyyy

Manual Serial No.

QM-4

Revision No: 0

DISTRIBUTED TO CONTROLLED COPY NO.

1) Managing Director Copy-1 2) Quality Assurance Copy-2 3) Marketing Copy-3 4) ISO Company Representative Master 5) 6)

Reasons for Revision:

mm/dd/yy 1) First time issued for (your company name)

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0.0 Scope and Field of Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.1 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2.0 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.0 Quality Management System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.0 Quality Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.1 Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.1.2 Responsibility and Authority. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2.1 Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2.2 Management Representative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2.3 Management Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.3 Quality System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.2 Contract Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.3 Design Control (not applicable) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.4 Document and Data Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.5 Purchasing (not applicable) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.6 Customer-Supplied Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.7 Product Identification and Traceability . . . . . . . . . . . . . . . . . . . . . . . .4.8 Process Control (not applicable) . . . . . . . . . . . . . . . . . . . . . . . . . . . .4.9 Inspection and Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.10 Inspection, Measuring, and Test Equipment . . . . . . . . . . . . . . . . . . . 4.11 Inspection and Test Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.12 Control of Nonconforming Product . . . . . . . . . . . . . . . . . . . . . . . . . 4.13 Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.14 Handling, Storage, Packing, and Delivery . . . . . . . . . . . . . . . . . . . . . 4.15 Quality Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.16 Internal Quality Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.17 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.18 Servicing (not applicable). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.19 Statistical Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.20 Appendix IV (Reference SOPs)

This manual provides reference to the organizational quality management system to ensure consistency, reproduceability, and continuous improvement in the company’s operations with a particular reference to customer satisfaction and to meet regulatory requirements as appropriate. The manual refers to the elements of international standard ISO 9001:2000 incorporated in the already existing ISO 9003 (1994) quality manual.