A product’s quality, reliability, and safety depend to a great extent on its conformance to specifications that have been tested, proven safe, and approved. This is particularly critical in products that have direct impact on public health and safety, such as medicines, medical devices, cars, household appliances, and other consumer goods.
For this reason, the proper handling of nonconforming products is incorporated in Food and Drug Administration (FDA) regulations covering drugs, medical devices, and biologics, and ISO international standards, which apply to manufacturers of a wide range of consumer goods.
FDA compliance is mandatory for life sciences manufacturers and related industries covered by the agency’s jurisdiction. Non-life science manufacturers comply with other federal regulations, but most of them also adhere to ISO quality standards, either voluntarily, or as part of compliance with requirements of countries where they want to sell their products.