Team NB Defines Manufacturing Site Hybrid Audits in Updated Position Paper

Hybrid audits, where at least one auditor is present on the premises of the manufacturer and other team members participate remotely, will satisfy the requirements for site audits of medical device manufacturers, according to a newly edited second version of a position paper from the European Association of Medical devices Notified Bodies (Team-NB).

A notified body is an organization designated by an EU country to assess medical products before they go on the market, review performance after a product is on the market and whether manufacturers meet quality standards.

Hybrid audits came into use during the COVID-19 pandemic and “when appropriately planned, are effective” and have several advantages over fully on-site audits, the paper says. Advantages include using 25 percent less of auditor’s capacities, reducing travel time and reducing burnout for auditors.

Audit planning is key, the paper says, requiring that notified bodies consider the manufacturer’s capability and suitability to support a hybrid audit such as by having the needed IT systems, electronic quality management documentation and records.

Read the position paper here.

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