ISO 9000 Certification & ISO/TS 16949

Basic SPC Requirements

Regardless of the specifics of each paragraph, there are four requirements that are common to all: Management must: Understand, Document, Implement and Demonstrate the effectiveness of the quality system.

The emphasis is upon management. In other words, the top management of the firm must not only allow or provide for a quality system, they must be actively involved with it. They do not have to be technical experts, such as statisticians or quality engineers, however, they must understand what the ISO 9001 and/or ISO/TS 16949 requirements are and provide for their effective documentation and implementation. Lip service is insufficient. Consequently, when it comes to statistical applications, top management must be sufficiently knowledgeable to provide for proper training, assure that the selected tools are properly implemented and that the results are utilized to maintain and improve the system.

Following clauses from ISO 9001 and/or ISO/TS 16949 impact the use of SPC:

	Clause 8.1 General: plan, monitor, measure, and analyze.
	TS2 Clause 8.1.1 Identification of statistical tools: identify appropriate statistical tools during the advanced quality planning process.
	TS2 Clause 8.1.2 Knowledge of basic statistical concepts: variation, control (stability), process capability, over-adjustment.

In reality, with what is known and published about the power of applied statistics, it is practically incumbent upon management to apply one or more statistical techniques to the control of the manufacturing process. Consequently, in a modern manufacturing environment, it would be rare to find a process that could not benefit from the power of statistics. The decision, then, is not so much if to apply statistics, but which statistical tools to apply. This gets to the requirement to "Determine appropriate statistical tools." And, by extension, the selected tool must be applied and implemented correctly.

Abstract Introduction of ISO 9001:2000 The Intent of ISO 9001:2000 The Requirements of ISO 9001:2000 Concluding comments on ISO 9001:2000 Appendix – Process auditing

What are the benefits of ISO 9001? What is the difference between ISO 9001 and ISO 9001:2000? What is the process for ISO 9001 certification? Why choose SQA for your ISO 9001 certification?

Linking ISO 9001:2000 requirements to Product/Service Quality ISO 9001 & ISO/TS 16949 - Management Sins Relative to Statistical Process Control