Are Internal Auditors Really Independent?
While an organization’s auditing group may be independent of a function to be audited within the company, it remains a part of the same corporate quality system, rendering it susceptible to systems issues that may exist. Additionally, corporate cultural biases may make it difficult to obtain a truly independent examination of the organization’s quality management systems, regardless of its size.
Utilizing the services of an external auditor will provide a totally independent examination of the organization’s quality management system. An experienced auditor, especially one who is a trained ISO 13485:2016 lead auditor and experienced with FDA medical device regulations, will be able to identify “weak links” in the organization’s system, that, if left unattended, may cause product safety, effectiveness and performance problems as well as regulatory non-compliance issues down the road.
Audits as a Learning Tool
Auditing as a service can provide various benefits and results:
- Auditing, by the book, against the organization’s documented quality management system, resulting in documented nonconformities and opportunities for improvement.
- Performing more extensive quality systems gap analysis to identify not only compliance issues, but providing recommendations to improve its effectiveness.