If we subcontract sterilisation, what if they won’t give us information on changes to their steriliser or details of the equipment?

Your contract with the subcontract sterilisation company should require them to provide you with information if needed on some of their activities (as relevant to the sterilisation process). These types of things may include installation qualification, operation qualification, calibration, maintenance, repair activities, etc. It is common that the sterilisation subcontractor will allow you to look at some of these on-site but would not give copies to you (e.g. for commissioning records). Your contract should require the sterilisation facility to provide any records necessary to demonstrate compliance directly to your notified body. In practice, if they are certified to ISO13485 and to the harmonised sterilisation standard and this certificate is issued by a notified body then we don’t tend to look at these unless there is a concern. I would expect the sterilisation contractor to give you a summary of any major steriliser maintenance or at least confirm that if they have done something, then they suitably re-qualified the chamber afterwards (IQ/OQ).

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