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Fundamentals of Quality Management

Fundamentals of Quality Management

EduGradus

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The course Fundamentals of Quality Management covers the evolution of quality, which moved from reactive inspection to strategic and systemic management, integrated across all stages of the production process and oriented toward customer satisfaction.

The Quality Management Systems (QMS) are based on standards such as ISO 9000, ISO/IEC 17025, and Good Manufacturing Practices (GMP), supported by principles of leadership, process-based approach, and evidence-based decision-making. Continuous improvement is applied through the PDCA Cycle, ensuring operational excellence.

Hierarchical documentation (Quality Manual, SOPs, records) ensures traceability and transparency. In the laboratory, Quality Assurance (planning, audits) is distinguished from Quality Control (calibration, control charts, proficiency testing), ensuring accuracy, precision, and reliability in analytical results.

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