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:
Read more about this topic: Quality Management System
Famous quotes containing the words quality, system, medical and/or devices:
“Upon the whole, necessity is something, that exists in the mind, not in objects; nor is it possible for us ever to form the most distant idea of it, consider’d as a quality in bodies. Either we have no idea of necessity, or necessity is nothing but that determination of thought to pass from cause to effects and effects to causes, according to their experienc’d union.”
—David Hume (1711–1776)
“Human beings are compelled to live within a lie, but they can be compelled to do so only because they are in fact capable of living in this way. Therefore not only does the system alienate humanity, but at the same time alienated humanity supports this system as its own involuntary masterplan, as a degenerate image of its own degeneration, as a record of people’s own failure as individuals.”
—Václav Havel (b. 1936)
“They said I’d never get you back again.
I tell you what you’ll never really know:
all the medical hypothesis
that explained my brain will never be as true as these
struck leaves letting go.”
—Anne Sexton (1928–1974)
“The relationship between mother and professional has not been a partnership in which both work together on behalf of the child, in which the expert helps the mother achieve her own goals for her child. Instead, professionals often behave as if they alone are advocates for the child; as if they are the guardians of the child’s needs; as if the mother left to her own devices will surely damage the child and only the professional can rescue him.”
—Elaine Heffner (20th century)