Quality Manual and Associated Documents

ISO 9001 requires the organization to create a quality manual.  The quality manual pulls together the quality management system (QMS) into one document.  This document is an overview of the quality management system.  It references other documents that describe elements of the QMS in more detail as needed.

If you search for quality manuals, you will discover many companies that sell canned quality manuals, and quality manual templates.  I recommend that companies write their own manual with the guidance of a quality management consultant, It is not that difficult to write one and it gives the organization ownership of the document.

A key component of the quality manual is the scope.  Here the organization describes the nature of the company's business, the elements of the business that the QMS applies to, and the elements of the standard that are being excluded.  As an example of an element exclusion,  if the organization does not design its own products, then it would exclude section 7.3 Design and development.

The quality manual should address each section of the ISO 9001 standard.  While not required, it is recommended that the mumbering of  the sections of the manual coincide with the section numbers in the standard, and that they be in the same order as the standard.  This helps with gap analysis, and makes it easier for the external auditor to understand your QMS.

In addition to the quality manual, ISO 9001 requires the organization to write some procedures.  The specific required procedures are:

• Document control
• Control of records
• Internal audits
• Control of nonconforming product
• Corrective action
• Preventive action

The quality manual will not detail these procedures but will merely make reference to them.

No other procedures are required, unless the absence of those procedures would affect the quality of the product or service provided by the organization.  In general, organization find it necessary to write a few more procedures to assure that the quality system is effectively implemented and the organization properly trained.

With a well written quality manual, and a few documented procedures, the organization is well on its way to certification.