Audits for EN ISO 13485, FDA/QSR and CMDCAS (Canadian)
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Medical device manufacturers are required to audit their quality management systems on a regular basis, in order to ensure continued compliance with the regulations. Qserve Consultancy’s team of certified Lead Auditors for EN ISO 13485 and EN ISO 9001 can assist you with or carry out these audits for you. In order to assess an organization for compliance to the appropriate regulations and standards it is necessary to audit the various processes, their interfaces, and functions. Qserve provides GAP Analysis audits of all relevant processes, including design control, quality management systems, management responsibility, process control, validation, maintenance and calibration, training, distribution, corrective actions/preventive actions (CAPA), complaint handling, medical device reporting/vigilance and clean room and microbiological monitoring. More than just auditing, based upon many years of industry experience, Qserve will recommend practical solutions to any observations to enable your organization to come into full compliance in the most efficient and cost effective way possible. Qserve can also audit your suppliers and distributors.
In the event your company is inspected by a Notified Body or the FDA, Qserve can prepare and attend the inspection and serve as a liaison between your company and the auditor(s). This can be especially useful when language may be an issue. In partnership with Qserve America, we have considerable expertise in guiding medical device companies through FDA inspections and conducting mock FDA audits.
FDA mock audits
Should you require further information about these services, please click on the tabs above or contact us . Internal audits are essential to your continuous improvement process and are obligatory for compliance with your product CE Marking and international regulatory compliance. Our program not only consists of advice and assistance with internal audits, but we also give management advice to improve your Quality Management System and business process. We have formats, checklists and programs to assist you, or we can carry out the internal quality system audit for you.
Your supplier is an integral factor in your Quality Management System. Our program helps you with the implementation of your supplier quality audits and compliance to international regulations. The recommendation of the Notified Body or FDA or other international regulatory body to ensure regulatory compliance of your supplier within your quality management system makes you, as a manufacturer of medical devices, responsible for checking for the presence of a quality system at your supplier. We have formats, checklists and programs to advise, assist, or carry out the supplier audit, for you.
Qserve can assist you in preparing FDA inspections by guiding you through the process in the form of a FDA mock audit. Qserve qualified lead auditors using ”Quality System Inspection Techniques” (QSIT) can mimic FDA inspectors and assess GMP,GLP, GCP, and QSR processes within your company, in preparation for an FDA inspection and testing internal systems and personnel. We can provide you with techniques for the efficient organization of FDA audits and the management of multiple inspectors. If required, we can attend the audit, serving as a liaison between you and the FDA. Qserve’s auditing deliverables include:
- Audit Plan
- Audit Findings
- Discussion of findings
- Recommendations for improvement and achieving compliance
- Audit report- assessment consistent with Notified Body definitions- Major non-conformities, Minor non-conformities and Recommendations; or FDA definitions- No Action Indicated (NAI) Voluntary Action Indicated (VAI) and Official Action Indicated (OAI) Follow-up of remedial actions, CAPA’s (Corrective and preventive actions).