(1) Quality Manual
The Quality Manual describes the overall quality management system of the company. Writing the Quality Manual is usually the starting point of developing the ISO 9001 documentation. ISO 9001:2000 requires the Quality Manual in section 4.2.2
2) Six Quality Procedures
The Quality Procedures describe in relatively general terms the overall process flow, its interaction with related processes, as well as the distribution of authorities and responsibilities. Writing the Quality Procedures is usually regarded the most difficult part of developing the ISO 9001 documentation. ISO 9001:2000 requires the Quality Procedures in the following sections:
- ISO 9001:2000 section 4.2.3 (Control of Documents)
- ISO 9001:2000 section 4.2.4 (Control of Records)
- ISO 9001:2000 section 8.2.2 (Internal Audit)
- ISO 9001:2000 section 8.3 (Control of Nonconforming Product)
- ISO 9001:2000 section 8.5.2 (Corrective Action)
- ISO 9001:2000 section 8.5.3 (Preventive Action)
(3)Quality Policy
The Quality Policy is the top-level policy directive regarding quality and customer satisfaction. It is usually a short one- to two-paragraph statement. ISO 9001:2000 requires the Quality Policy in section 5.3.
(4) Quality Objectives
Quality Objectives are designed to support the Quality Policy. They are specific and measurable goals. As the goals are met, new goals are set. ISO 9001:2000 requires Quality Objectives in section 5.4.1.
(5) Process Flowchart
ISO 9001 requires "a description of the interaction between the processes of the quality management system". Though this description can be in an form, a flowchart is a very appropriate format. ISO 9001:2000 requires the "description" in section 4.2.2.
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