Quality & Regulatory Compliance

Deming & Amgen

Deming defined Quality using these terms: "Costs go down and productivity goes up, as improvement of quality is accomplished by better management of design, engineering, testing and by improvement of processes. Better quality at lower price has a chance to capture a market. Cutting costs without improvement of quality is futile." Amgen further enhances this definition with elements of Regulatory Compliance, stating that "Quality Assurance and Quality Control activities should be performed effectively to ensure that products are designed, studied, manufactured, and tested to meet appropriate quality criteria. These activities should also be performed in accordance with applicable state, federal and international laws and regulations. Accurate and sufficient documentation should be provided for all appropriate processes and results."

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