Information for manufacturers and verifiers.
You should apply for a pre-assessment if you are unsure whether your product or quality management system will satisfy certification requirements.
The purpose of pre-assessment is to help you understand the requirements, either in relation to the type of instrument you wish to get certified, or your quality management system for production or verification. In the latter case, our pre-assessment will be an audit highlighting any areas of deficiency. As it does not result in a certification decision, it is a way for you to confirm your process is robust before proceeding to quality management system certification.
Please note that we are not permitted to provide consultancy as a Notified Body. As a result, we cannot resolve issues or tell you what to do. However, we can give our insight into the requirements and clarify them in the context of your circumstances. We can also direct you to existing advice and guidance that may be of assistance.