Clients are being notified of a recent development from the Notified Body BSI that it will be increasing the number of unannounced ISO audits for high-risk devices or for noncompliant manufacturers. The following Industry Update provides insight about their thinking on this new initiative.
After a trial period in March 2014 and a round of internal trainings from May to June, Notified Body BSI has launched its full global roll out of unannounced audits and will conduct up to 300 company visits in the remainder of 2014, according to Vicky Medley, head of QMS at the company.
Medley was one of the speakers at BSI’s webinar on the current status of the implementation of the practice.
What are Unannounced audits?
Unannounced audits were a part of the EU Commission recommendation published in September 2013 in the aftermath of the PIP scandal, and are likely to become a part of the new Draft Medical Devices Regulations.
Unnanounced audits are in addition to the regular visits and can be conducted at the manufacturer or critical subcontractor or crucial supplier or both. The EU requires Notified Bodies to make unpredictable additional visits at least once every third year with a higher frequency for high-risk devices or for noncompliant manufacturers.
Overview of the audits and auditors:
The teams from BSI will consist of at least two assessors, one QMS assessor and one product technical specialist. Very large manufacturers with several-hundred employees or more will likely be visited by two assessors for two days. Manufacturers are required to provide Notified Bodies with access information, such as hours of operation, contact names and phone numbers, language skills on site, shutdown periods, etc.
Preparation for the Audits:
To prepare for unannounced audits, companies should study the requirement, factor additional costs into budgets, implement processes and procedures for receiving visits, respond to any requests from notified bodies, review critical subcontractors’ and crucial suppliers’ contracts, communicate awareness across all staff and train appropriate staff and finally practice the procedure.
Any questions please contact mdi at firstname.lastname@example.org and ref: Unannounced Audits.