Module 17 2024

05/12/2024

Implementation of UA’s by Notified Bodies • UAs are generally conducted by 2 x auditors. The standard time allocation is 2.5 days: 2 man-days on site (2 auditors x 1 day) and 0.5 man-days for offsite audit preparation. For complex and Class III devices, this may be increased to 3.5 days: 3 man-days on site (2 auditors x 1.5 days) and 0.5 days offsite. • UA teams will work in parallel and not together. • UAs are the audit of 1 x device only, which is decided by the Notified Body before the UA is undertaken. UAs are not an overview of devices. They are specific to one device. Primarily concerning the manufacturing and functional testing of the device • UAs are not reviews of the full Technical Documentation. Areas such as BOMs, raw materials, manufacturing processes, and testing processes are significant areas for review during a UA.

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Implementation of UA’s by Notified Bodies

• Audit teams should have a Letter of Authority from their Notified Body and also carry identification of their NB employment. • If there are issues relating to entry, e.g., visa issues or issues of entry to a sensitive site [e.g., the site also makes military equipment, nuclear facilities…etc.]. This information should have been indicated to the Notified Body by the manufacturer in the UA Questionnaire, which Notified Bodies require their clients to complete. • UAs generally are not conducted within two weeks of a scheduled audit • UAs are standalone audits and should not be linked with scheduled audits by the Notified Body. For example, to carry out an ETS or close non conformances raised at a scheduled audit.

The Organisation for Professionals in Regulatory Affairs

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