A Closer Look: QMS Audits in the Medical Device Industry (Part 3)
24 November 2011
On November 7, this blog explored the topic of inadequate control over suppliers and how it continues to be top-of-mind to many organizations. Today, this blog will further look at this topic of inadequate control.
Manufacturers often mistakenly rely completely on the fact that their suppliers undergo some types of inspections/audits by regulatory authorities or third parties and hold some types of approvals or certifications. What they don’t understand is that this oversight does not relinquish their responsibility as a manufacturer to establish controls over products and services obtained from suppliers and to maintain evidence that such controls are effective to ultimately ensure the provision of safe and effective devices.
Regulatory authorities and third parties will inspect/audit a manufacturer to confirm that
objective evidence of control over products and services from suppliers is available at the manufacturer’s site. Failure to have any evidence on-site, or provide access to any objective evidence of the controls associated with products and services from suppliers, could result in the manufacturer’s quality management system being non-compliant.
This blog entry concludes the three-part series on QMS audits in the medical device industry.