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| Chapter | /Section | Title |
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| 49 | 15 | 15 |
| 15.12 | Documenting the System | |
| 15.12 Documenting the System Many professionals and consultants associated with ISO 9000 registration have recommended organizing documentation into the following four levels: Level I - 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. | ||
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