A Closer Look: QMS Audits in the Medical Device Industry

24 Oct 2011

In recent blogs, the topic of risk management has been addressed. But what about quality management system (QMS) audits? Today, this blog will explore the most common areas where nonconformities are found during quality management system audits in the medical device sector.

Based on Intertek’s experience in this industry, the most common findings written during quality management system audits are: 

• Inadequate risk management process: Risks/hazards not addressed, not recorded or risk management file not updated regularly, only risk analysis on product vs. risk management (throughout product realization)
• Inadequate control over suppliers: Selection, evaluation and re-evaluation criteria not defined, documented agreement missing or inadequate
• Inadequate QMS documentation: Applicable regulatory requirements not addressed or improperly addressed in QMS documentation, not keeping up to date with regulatory requirements

Over the next 3 weeks, we’ll review each of these topics in more detail.
To learn more and/or to speak with an Intertek expert on this subject matter, please send an e-mail to askmedical@intertek.com or visit www.intertek.com/medical.