Level 1 - Quality Policies and Objectives. This first level of documentation
is often referred to a "Quality Manual" and is separate and distinct from
other procedures. The purpose of this level of documentation is to state in a concise
and brief format, the policies and objectives of the company for achieving a desired
level of quality for the organization or division.
At a minimum, the Quality Manual is required to address each one of the paragraphs
of the applicable ISO Series (9001, 9002 or 9003) that the company plans to become
registered against. Each area that is written should include three parts: Scope,
Policy and Responsibilities. The Scope portion should simply state the purpose of
the covered area. The Policy portion should state the company policy regarding the
applicable ISO clause and the Responsibility portion should state whom, in generic
titles or positions, is responsible for the policy.
Although there is no standard format or requirement for the Quality Manual, a sample
manual is provided in section three of this guide.
Level II - Departmental Procedures and Responsibilities. The second level
of documentation should be more detailed and should address the procedure(s) of
an activity for a department or function and the personnel (generic titles or positions)
responsible for accomplishing the procedure(s). These procedures can be organized
on a departmental basis but a better method may be to organize them on a functional
basis in accordance with the outline of the 20 elements delineated by ISO 9001,
when applicable. Samples of Level II type documentation are provided in section
4 of this guide.
Level III - Work Instructions. This level of documentation would be very
detailed on "how" to accomplish one specific job, task or assignment.
For example, a work procedure could be developed for assembling the final housing
of a product with step-by-step instructions including such detail as the torque
requirements of the fastening screws.
Level IV - Forms and other Documents. The last level of documentation can
include forms, records and other documents used in the production or delivering
of a product or service. Samples of quality type forms and other documents are provided
in Section 5 of this guide.
