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The goal of every operation or production system is to generate a useful product. Most quality-control methods were initially developed to aid manufacturing. This is not surprising because high volume production typically requires many repetitions involving a controlled sequence of operations. Not all of the many approaches to quality control are equally effective. Nonconformities in laboratory testing are caused basically by excessive process variation and mistakes. A critical limitation of the statistical quality control - based methods is that they are ineffective in detecting and controlling mistakes, the dominant source of nonconformities in most organizations today. Statistical quality control can effectively control process variation, but it cannot detect or prevent most mistakes. Six Sigma belongs to statistical quality control and provides a new methodology for measuring process performance and refines earlier methodologies for making process improvements. Six Sigma Quality Management is slowly making inroads in healthcare organizations and offers a real hope for improving quality management thinking and processes. The reason is that Six Sigma focuses on defects, which in turn requires that goals for good quality be defined. Six Sigma provides a universal methodology for measuring quality by counting the defects, determining the defect rate as »defects per million« or »DPM«, and then converting DPM to a sigma-metric (by use of standard tables available in any Six Sigma text). To reduce (and oversimplify) Six Sigma, there now are »Sigma metrics« that provide a universal benchmark for process performance. The performance of all processes can be characterized on the »Sigma scale.« Values typically range from 2 to 6, where the goal for »world class quality« is 6. Based on the data from real-world health laboratory is an obvious statement that current instrumentation performs well. The new generation of clinical analyzers have achieved some high Sigma metrics. Customers in healthcare are going to enjoy a new era empowerment with instruments and methods that perform at 6 Sigma or higher.