The effective audit of a device manufacturer’s quality management system (QMS) is key to maintaining compliance with the regulatory requirements in a dynamic business environment. New products, new markets and company expansion can all place unanticipated burdens on a previously smooth-running system, potentially jeopardizing product launch or regulatory compliance.
Internal audits are critical to the successful operation of any quality system, but these must be conducted with an understanding of not only the applicable standard or regulation, but also how an external auditor will view the system. In addition to internal audits, therefore, it is often helpful for independent auditors to perform periodic audits, to provide an ‘outsider’s’ view.
When independent audits are embraced as a part of the company’s own regular audit process, the resulting compliance improvements will often lead to industry best practice and successful regulatory agency audits. As a result, compliance can become a strategic tool in achieving greater levels of competitiveness and business activity.
GEMARMED can help ensure your quality system meets the applicable requirements, be they FDA GMP, ISO 13485, MDD Annex II, CMDCAS, etc. Feel free to contact us and see how we can assist.