Editing Quality management system (section)

==Medical devices==
The two primary, state of the art, guidelines for medical device manufacturer QMS and related services today are the [[ISO 13485]] standards and the US FDA [[21 CFR 820]] regulations. The two have a great deal of similarity, and many manufacturers adopt QMS that is compliant with both guidelines.

ISO 13485 are harmonized with the European Union [[Regulation (EU) 2017/745|Regulation 2017/745]] as well as the IVD and AIMD directives. The ISO standard is also incorporated in regulations for other jurisdictions such as Japan (JPAL) and Canada (CMDCAS).

Quality System requirements for medical devices 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.<ref>{{Cite web|title=Homepage {{!}} ISPE {{!}} International Society for Pharmaceutical Engineering|url=https://ispe.org/|access-date=2020-07-31|website=ispe.org|language=en}}</ref> 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.<ref name=":1"/>

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.<ref name=":1">{{Cite web |date=2005-11-24 |title=2005 CFR Title 21, Volume 8 |url=http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr820_05.html |archive-url=https://web.archive.org/web/20051124161242/http://www.access.gpo.gov/nara/cfr/waisidx_05/21cfr820_05.html |archive-date=2005-11-24}}</ref> 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 7 essential subsystems of a quality system. These subsystems include:
[[Image:Qualsystem1.png|thumb|Quality system]]
* Management controls;
* [[Design controls]];
* Production and process controls
* Corrective and preventative actions
* Material controls
* Records, documents, and change controls
* Facilities and equipment controls
all overseen by management 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 manufacturers are regulated under a different section of the [[Code of Federal Regulations]]: