Get Quality Management System (QMS)
ready with an internal and external audit
The goal of an internal audit is to ”provide independent assurance that an organization’s risk management, governance, and internal control processes are operating effectively.” Specifically, the purpose of the process is to assess the organization and determine, based on assessment findings, whether the company has adequately followed the guidelines.
It is beneficial for medical device companies to conduct unofficial internal audits prior to an official audit by a Notified Body, Authorised Auditing Organizations or Health Authorities, to ensure full compliance of quality and regulatory documentation. For ISO 13485 and FDA – 21 CFR Part 820 it is also a compulsory requirement for a company to internally audit its QMS.
Internal audits are performed by either a company employee or by an external expert. The advantage of bringing in a third-party professional auditor is that the company will receive an objective review of the processes within its QMS. The output of an internal audit is a comprehensive, objective, bias-free report assessing compliance with the audited requirements.
The most common standards for which medical device companies need to prepare for:
- ISO 13485– Medical devices — Quality management systems — Requirements for regulatory purposes
- FDA – 21 CFR Part 820 – FDA SUBCHAPTER H – MEDICAL DEVICES, PART 820 QUALITY SYSTEM REGULATION
How can we help?
GemarMed has hands-on experience in conducting fully independent quality system reviews for companies at different stages of the certification processes. Since 2010, GemarMed’s experts have helped clients prepare for the external audit by serving as an internal auditor surveying the client company and ensuring its quality systems are compliant with the standard requirements. Our vast experience has supported our clients through hundreds of successful audits.
In short, we at GemarMed have the experience, expertise, and passion to help companies simulate and pass audits.