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Improvement loop advances quality but needs more work
One of the key additions to ISO 9001:2000 is a subclause 8.5.1 requirement for continual improvement. This requirement is a definite advance over ISO 9001:1994, which relied only on corrective and preventive action to improve the quality management system (QMS).
Subclause 8.5.1 requires the organization to "continually improve the effectiveness of the QMS through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review." If fully implemented, this plan-- do-check-act cycle should result in iteration after iteration of improvement. First, let's look at each of the elements of this improvement loop.
Policy and objectives
Top management must ensure the quality policy (subclause 5.3) "provides a framework for establishing and reviewing quality objectives." Thus the policy must be translatable into measurable objectives (subclause 5.4.1) that include the ones needed to meet product requirements while being consistent with the quality policy. Top management's goals must be put into practice using measurable objectives to stimulate improvement.
Audit resuits
The next element in the improvement loop is the "results of audits" step performed by the organization. This element includes internal audits defined in subclause 8.2.2. Deer audits, second- and third-party audits and other audits performed by the organization. Audit results provide one tool for understanding the status of the QMS. The other key tool is the analysis of data.
Data analysis
Subclause 8.4 requires the organization to "determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS." The data must also be used to evaluate where the effectiveness of the QMS can be improved.
The analysis must "provide information relating to customer satisfaction, conformity to product requirements ... and suppliers." The information must also relate to "characteristics...