There is a deliberate emphasis on performance improvement—and actions to make it a continual process. Keep that in mind as you read this clause. Additionally, this section is closely aligned with its companion document—ISO 9004:2000. Be sure to read that standard as well to fully understand the performance improvement concept.

8.1 General

The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed

 a) to demonstrate conformity of the product,

b) to ensure conformity of the quality management system, and

c) to continually improve the effectiveness of the quality management system.

 This shall include determination of applicable methods, including statistical techniques, and the extent of their use.

(From BS EN ISO 9001:2000)

Clause 8 encompasses actions to check, measure and improve the quality system and the business as a whole. To get there, however, planning is necessary and a significant part of 8.1. Organizations need to think about all of the necessary processes that are used to achieve product conformance, i.e., customer requirements. Consider these issues when addressing this clause:

* The other planning elements of this standard, such as 4.1 General Requirements, 5.4.2 Quality Management System Planning and 7.1 Planning of Product Realization should be included in the planning stage.

*  The development of a continual improvement program (if one doesn’t already exist) is encouraged.

*  The entire clause is applicable to everyone—regardless of size or scope.

In terms of documentation, the clause only requires organizations to measure and document what they think is appropriate.

The last section of this clause—“determination of applicable methods, including statistical techniques” requires that if organizations plan to use statistical techniques and identify how they’re going to use them. Although not a requirement now, the new standard strongly encourages that all organizations benchmark best practices in some way.