PMS Audit and Consulting Technical file
As a medical device manufacturer, you are obliged, according to the ISO 13485:2016 standard, to audit your quality management system (QMS) on a regular basis.
Your certification body will, during their audit, verify the responsibilities and requirements for planning and conducting audits and the recording and reporting of the audit results.
Important is to show, you take all necessary corrective actions to eliminate detected non-conformities and their causes.
We offer a transparent process and make sure that the report is in compliance with ISO13485 :2016 and will be accepted by the notified body.
As a certified lead auditor, Eclevar regularly conducts on-site manufacturer audits.
Audit execution includes liaising with the supplier to confirm appropriate dates, reaching consensus on the audit agenda, completing the audit at the supplier’s facility as per the appropriate medical device regulations and finalising the audit report including findings.
Eclevar also acts as the lead internal auditor for a number of clients.
We collaborates to finalise the annual internal audit schedule, completes on-site quality system audits at the client’s facility and issues the internal audit report.
Eclevar has delivered numerous custom-made training sessions for clients wishing to increase their knowledge and understanding of the industry.
Training on the CE mark process, risk management in the medical device industry including the ISO 14971:2012 updates, EU MDR update analysis, industry trends and general medical device training for non-quality staff have been successfully delivered and have received positive client feedback.