Quality Manual Introduction
The quality manual is the most audited, most critical and most static document in the quality system. It is the top of the documentation pyramid because it establishes the quality policies that the lower level procedures must follow.It is also the most focused document on fulfilling the requirements of the standard.
Most of a basic quality manuals is based on addressing every SHALL in the ISO 9001:2000 standard. The quality manual will use similar text as the standard but will replacing the word SHALL with the word DO. The standard says that an ISO 9000 certified company SHALL maintain a corrective and preventive action systems and the quality manual says the company DOES maintain a corrective and preventive action system. In addition, the standard says that quality responsibility shall be defined and the quality manual defines the responsibilities of key personnel. The quality manual also includes the high-level quality statements.
The quality manual is a high-level document and should not include too much detail. If there is too much detail, then it will require changing in revision level. Usually the quality manual is distributed in paper versions so updates are very expensive. In most companies the lower level documents are maintained electronically so changing them is quick and easy. Therefore it is best to put the detail instructions in your level-2 procedures and just refer to these procedures in the quality manual. There are many companies on the web that are selling quality manuals. Many of these manuals are setup for easy editing. I highly recommend that no one wastes the time and energy to write a quality manual from scratch. Your time is much better spent adapting a manual that has successfully passed certification audits and has all the right phrases that the auditor are looking for. Adapting an existing manual (like the one on this site) will have several benefits:
- It will suggest improvements to your quality system
- Give you quick compliance in area that are not critical to business operation
- Allow you to focus on the areas where you do NOT have existing compliant documentation
- Increase the chance of passing your first external certification audit
Sample Quality Manuals
The quality manual presented on this site is a universal manual that is about 40 pages long. If has been used primarily at for manufacturing companies. Some of the sections should be deleted if it is being implemented at a design house, trucking company, or service organization. It has been both ISO 9001 and ATEX audits. It is a good example for a small to medium manufacturing company but is applicable to other applications. Feel free to copy it and adapt if for your own use but please do not try to sell it or re-publish it on the web.
Quality Manual (Section 1,2,3)