EN ISO 13485 and EN ISO 9001 audits

As part of the ISO 13485 and ISO 9001 manufacturers of medical devices are required to audit their quality management systems on a regular basis. In this way they can demonstrate continued compliance with the regulations.

Internal audits: The manufacturer shall conduct internal audits at planned intervals to determine whether the quality management system conforms to the regulations and standards and is effectively implemented and maintained.

External/Supplier audits: As your supplier is an integral factor in your quality management system, you, as a manufacturer of medical devices, have to ensure regulatory compliance of your supplier. This can be achieved by performing audits at the supplier’s premises.

Notified Body or other authorities audits: Your company is inspected by a Notified Body or the e.g. the FDA, for verification of (continued) compliance to the standards and regulations.

Medical Device Project has certified Lead Auditors for ISO 13485 and ISO 9001 and can assist you with these audits. In the case of Internal and/or External/Supplier audits we also can carry out these audits for you. In case of Notified Body or other authorities audits we can prepare and attend the audit inspection and serve as a liaison between your company and the auditor(s).

Furthermore, when organizations need to be assessed for compliance to the appropriate standards or regulations, we can carry out a GAP analysis audit of all relevant processes, such as design and development, quality management system, responsibilities, production, validations, maintenance, complaint handling, vigilance and corrective actions/preventive actions (CAPA). In those cases we will report the gaps but also provide practical solutions to the observations made.