Auditing Quality Systems

Quality Systems are the policies and procedures by which a manufacturer manages the design and fabrication of a product. To ensure that safe and effective devices are manufactured National Regulatory Authorities (NRA) require evidence that a satisfactory Quality System is implemented by the manufacturer. For high risk IVD Medical Devices that are considered a potential hazard to pubic health auditing the Quality System may include visiting the site of manufacture by a team of experts.  Audit visits require experts with a wide range of experience depending of the type of device and delays occur while waiting for audits. Preparing for and hosting audit visits is expensive for the manufacturer and duplication, where the same manufacturer is audited by different NRAs, causes delay and increases costs.

To reduce duplication mutual recognition of competent authorities should be encouraged, independent (third party) organisations capable of undertaking inspections should be identified and their use encouraged. Minimum standards should be identified for quality management in the manufacture of IVD medical devices to be used at the point of care.

Medical Devices Single Audit Project

The IMDRF MDSAP Working Group has developed a standard set of requirements for auditing organizations performing regulatory audits of medical device manufacturers’ quality management systems and a set of documents is available on their website. The MDSAP is intended to allow recognized Auditing Organizations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities. In addition to ensuring the quality of audits, avoiding duplication (where multiple agencies audit the same site).  The adoption of a single audit will reduce the costs and delays incurred during pre-market registration. A MDSAP Pilot program was initiated in January 2014. Participating NRAs are the Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada and US FDA. They will accept the MDSAP audit reports as a substitute for routine Agency inspections.

The IMDRF Single Audit Programme is a very welcome initiative towards increasing access to affordable IVD in the African region.

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Improving Access to Affordable Diagnostics