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ISO 9001 Quality Manual

This first step in building a Quality Management System is the creation of a "Quality Manual". This is a separate and distinct step from developing quality procedures. The purpose is to describe in a concise and brief format, the scope and extent of the company quality system.

More than likely the scope for your Quality Management System will come from your customers.  It is the customer that drives the Quality Process. The customers requirements, needs, and future desires are the basis for implementing an ISO 9000 quality system in the first place.

At a minimum, the Quality Manual is required to state (ISO 9001 requirement 4.2.2) your Quality Management System scope, exclusions, procedures used, and a process map detailing the sequence and interaction of your core process.

Many organizations choose to address each of the paragraphs of the applicable ISO Series that the company plans to become registered against. ISO 9001:2008 is the focus of this manual. But, you may need to expand the scope to include EMS 14001, ISO 22000, QS-9000, AS-9100, or other industry specific quality requirements.

ISO 9001 does not require a specific format for the Quality Manual. A sample manual is provided in this guide for your use as a template to create your own Quality Manual. The Quality Manual Table of Contents is based on the ISO 9001 standard itself. This ensures that each element is addressed and provides a starting point for building a complete Quality Management System.

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