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This guidance document is intended for medical device manufacturers and it is expected that the reader is familiar with regulatory quality management system requirements within the medical devices sector. This guidance document may also be useful to regulatory authorities and suppliers. This guidance document is intended for educational purposes and it is not intended to be used to assess or audit compliance with regulatory requirements. Existing regulatory requirements, such as Sections 4.1 and 7.4 of ISO13485:2003, Articles 5 and 37 through 39 of the Japanese Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and in vitro Diagnostics (MHLW Ministerial Ordinance No. 169, 2004), and the FDA 1996 Quality System Regulation 21 CFR Part 820, sections 820.50 Purchasing controls, and 820.80 Receiving, in-process, and finished device acceptance, which require organizations to control products and services obtained from suppliers. These requirements call for the type and extent of controls to be established and documented within the organization’s quality management system. Control could be defined and documented in the form of contractual arrangements, quality plans or other types of documents.

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