Level 2 --
Quality Procedures
The second level of documentation should be more detailed and 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.
Samples of Level 2 type departmental procedures and responsibilities documentation are provided in the ISO Policies and Procedures System. The ABR ISO9000:2000 Quality Procedures start with the designation "QP" and may be used as a template to create your own procedures. They are not the only format or method to accomplish the requirements.
The procedures in this manual provide format and verbiage to describe tasks and activities that are typical for organizations that meet ISO 9001:2000 requirements. They certainly are not the only format nor functional descriptions of these tasks and activities. They are intended to provide a foundation for you to develop the procedures that work for your company. As you rewrite the procedures for your application, be sure to verify your modifications against the requirements of the ISO standard to ensure all requirements are still addressed.
An example of where you may want to change the format is the Effectiveness Criteria section of certain procedures. Section 4.1 c) of the ISO 9001:2000 standard requires that the criteria and methods to determine the operation and control of processes are effective to be determined. It does not require the methods and criteria to be defined in the procedures; other methods may be used.
The primary reason this section was included in the procedures was to encourage thought in this area. Often times, effectiveness of a process, task, or activity is assumed to be known. The assumptions may not be verbally expressed and frequently there is no agreement between departments or even between employees in the performing department. Defining these criteria and obtaining consensus among interested parties can result in significant improvement.
When determining these criteria, a holistic approach as to what is best for the company should be used. An obvious example involves Purchasing. In the past, Purchasing effectiveness was measured by the purchase price of materials. The obvious fallacy with this measure is that out of specification or marginal components result in increase costs downstream and may actually result in higher total costs.
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