The Fundamentals Of Medical Device Quality System Auditing

Posted on

The FDA requires all medical device manufacturers and suppliers to undergo numerous quality audits, including process, product, and system audits. If your firm deals with medical devices and you need to know more about quality system audits, you are in the right place.

What Is a Quality System Audit?

A quality system audit confirms whether or not various components in a management system work efficiently and effectively. It also looks into the development, documentation, and implementation of these systems to ensure everything is in line with specific requirements. This type of quality audit examines your firm's QMS (quality management system) to ensure it conforms with statutory regulations, internal policies, and contract obligations.

Fundamental Principles of Medical Device Quality System Audits

Medical device quality system audits have several fundamental principles. They include the following.


Integrity stipulates that the auditor and everyone else in your company must act with diligence and honesty. Furthermore, no party involved should break regulatory requirements, demonstrate incompetence, or act unfairly.  


The information collected and used during a system audit is invaluable, and in the wrong hands, it could be used to defame your firm. Therefore, the process requires optimum confidentiality. Moreover, the auditor or your organization should not use this information for inappropriate personal endeavors.


Quality audits are required to be free from bias and partiality. Therefore, you should use an auditor without direct links to the section undergoing auditing. That is the best way of ascertaining impartiality and preventing conflicts of interest from tampering with the outcome.

Professional care and reasoning

Professional care means the auditor and organization need to be aware of the essential nature of quality system audits regarding medical devices. The auditor should also be duly qualified and reasonable enough to ensure the entire process is smooth and seamless.

Rational approach

Rationality in assessment and evaluation is indispensable when it comes to system audits. Therefore, auditors must use appropriate methods to ensure the audit process and results are dependable and intelligible.

Benefits of Medical Device Quality System Audits

System audits offer your firm numerous benefits, including the following.


The medical industry has various regulations for firms like yours, including properly auditing your systems. Therefore, to avoid severe repercussions like heavy penalties or eventually losing clients due to a damaged reputation, you must comply.


By independently verifying that your firm's statements genuinely reflect its current position, audits improve your credibility. That means your investors, clients, and stakeholders get to have more confidence in you and your operations.

Combat unethical practices

Companies often get exposed to malignant practices like corruption and fraud. A quality audit helps you isolate these issues and implement measures to stop them from occurring in the future. 

Contact a company that offers medical device quality system auditing services to learn more.