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GHTF: Strategies for Device Audits Should Focus on Quality Systems

October 25, 2010
Audits of device facilities should focus on the overall efficacy of the quality management system (QMS) rather than individual requirements, the Global Harmonization Task Force (GHTF) recommends in a new guideline on regulatory audit strategy. Breaking the QMS into subsystems, such as design and development or purchasing controls, can make it more manageable, the guideline says. Auditors should assess whether applicable subsystems and processes of the QMS operate as self-regulating control systems and are effective.
International Medical Devices Regulatory Monitor