This first level of documentation is often referred to as a "Quality Manual" and is separate and distinct from the procedures. The purpose of this level of documentation is to state, in a concise and brief format, what the scope of quality is for the organization or division.

Most organizations use their Quality Manual to address each one of the paragraphs of the applicable ISO Series that the company plans to become registered against. This is not required but most companies do it anyway. Some companies add their quality policy and objectives too. Again, this is not required but it is not a bad idea.

At a minimum, your quality manual must include:

Scope simply state what your company makes and note any exclusions to the standard. (only elements from clause 7 may be excluded)

Procedures You must include or reference the procedures that make up your quality maangement system.

Processes You must determine the sequence and interaction of your process.

People will use your quality manual as a table of contents to your quality system. It will show what is covered, what procedures are used, and what the process sequence is. In this way, auditors can plan an audit or understand where to find the information they need.

Although there is no standard format or requirement for the Quality Manual, a sample manual is provided in this guide for you to use as a template to create your own Quality Manual.

Next: What information is needed for Level 2 - Procedures and Responsibilities?