3: Quality Management Systems
- Page ID
- 39490
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Objectives
- Define a Quality Management System and outline its importance in quality
- Discover various quality systems – both voluntary and mandatory
- Understand what ISO is and how it helps a company with quality
- Learn the basics of quality management; TQM, continuous improvement, Six Sigma, 5S, Lean, and ISO.
- Explore how a company earns ISO certification and CGMP certification. Understand who audits/enforces either of these QMS.
- Understand the motivation a company must follow a QMS if they are not required to have one by law.
- 3.3: ISO
- Quality management is the primary concern of the ISO 9000 standard with its focus on product design, manufacturing, sales, and service. It is accepted in over 90 countries and applicable not only to product-focused organizations but service-oriented organizations as well (e.g., hospitals). This standard strives to involve employees at all levels to participate in the quality process.