If you're assessing compliance gaps between ISO 13485:2016 and its previous edition, it's critical to highlight the changes in QMS requirements and contextualize these questions accordingly. Has it been implemented and maintained properly?.Is it documented according to applicable requirements?.Has the QMS been established to the extent it needs to be?.Staying within these boundaries is critical for focusing your energy and hours where they should be while avoiding any temptation to pursue tangential goals.Īgain, in order to be successful, a QMS audit must focus on the system itself and the processes within it, answering important underlying questions, like: Simply stated, the goal of any QMS audit, no matter what standard is being evaluated against, is to determine whether your system is written as it should be, if that system is being maintained and followed properly, and that it's producing the right output. Gap Analysis Remediation: A Guide to Resourcing & Implementationįrom the very start, it's important to make sure everything is pointed at the same target. Planning a quality system gap analysis? Grab our free guide and learn how to turn your finished report into an actionable project plan: This starter guide offers some helpful guidance to help you orient yourself in the initial planning stage of such a project and how expert third party resources play an important role in ensuring these assessments are effective and efficient. Between planning, coordinating, and conducting the assessment, audits like this have many moving parts, each of which critical to the project's success. These audit programs can be daunting and complex, making it difficult to know where to start.

Medical device manufacturers and supporting organizations pursuing or maintaining an ISO 13485:2016 certification must conduct regular audits to ensure an adequate, effective quality system is established and maintained through a compliant Quality Management Systems (QMS).

Free iso 13485 internal audit checklist