A Closer Look: QMS Audits in the Medical Device Industry (Part 2)

07 November 2011

On October 24, this blog explored most common findings written during quality management system audits. These include: inadequate risk management process; inadequate control over suppliers; inadequate QMS documentation.

Specifically, the topic of inadequate control over suppliers continues to be top-of-mind to many organizations. Today, this blog will explore this topic and it will be continued on November 21.

Control over suppliers has been a hot topic for the last several years and despite all the information currently available, it still remains a widely misunderstood area.

In the medical device sector, regulatory authorities around the world hold one entity ultimately responsible for meeting the regulatory requirements when a medical device is placed on their market. But what does this mean? The responsibility for ensuring compliance with all applicable regulatory requirements, including quality management system requirements, cannot be delegated to suppliers.

According to guidance issued by the Global Harmonization Task Force (GHTF), a “Manufacturer” means “any natural or legal person who designs and/or manufactures a medical device with the intention of making the finished medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by a third party(ies).

Check back on November 21 as this blog will explore additional details relations to inadequate control over suppliers.
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.