Quality Management System - Quality System For Medical Devices

Quality System For Medical Devices

Quality System requirements for medical have been internationally recognized as a way to assure product safety and efficacy and customer satisfaction since at least 1983, and were instituted as requirements in a final rule published on October 7, 1996. The U.S. Food and Drug Administration (FDA) had documented design defects in medical devices that contributed to recalls from 1983 to 1989 that would have been prevented if Quality Systems had been in place. The rule is promulgated at 21 CFR 820.

According to current Good Manufacturing Practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations, in Part 820 of the QS regulation. As with GMP, operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements.

The FDA has identified in the QS regulation the essential elements that a quality system shall embody for design, production and distribution, without prescribing specific ways to establish these elements. These elements include:

• personnel training and qualification;
• controlling the product design;
• controlling documentation;
• controlling purchasing;
• product identification and traceability at all stages of production;
• controlling and defining production and process;
• defining and controlling inspection, measuring and test equipment;
• validating processes;
• product acceptance;
• controlling nonconforming product;
• instituting corrective and preventive action when errors occur;
• labeling and packaging controls;
• handling, storage, distribution and installation;
• records;
• servicing;
• statistical techniques;

all overseen by Management Responsibility and Quality Audits.

Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement procedures tailored to their particular processes and devices. For example, if it is impossible to mix up labels at a manufacturer because there is only one label to each product, then there is no necessity for the manufacturer to comply with all of the GMP requirements under device labeling.

Drug manufactures are regulated under a different section of the Code of Federal Regulations: