ISO 13485 internal audit

ISO 13485 internal audit

So, you are in the medical devices industry, and one of the first items you would come across in your profession is having to deal with an ISO 13485 audit. What is the ISO 13485, and what does it take to audit it?

Understanding the ISO 13485

First things first. Let us get to the root of the matter: What is ISO 13485? The ISO describes the ISO 13485 thus:

“ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services”.Thus, it is clear that ISO 13485 concerns itself with regulatory requirements for QMS.

Does my organization need an independent auditor for ISO 13485?

ISO 13485 requires many important parts. Some of these are:

  • Compliance Audit Program
  • Policy Audit Program
  • Procedures Audit Program
  • Process Audit Program
  • Records Audit Program

What is given here is only a small sample of the parts required to be audited. Come to think of it: Would your organization have the time or resources to implement these complex audits? Being in the medical device industry is strenuous to say the least. On top of it, apart from having to work on your core business, do you think it is wise to allocate resources for intricate tasks such as audits?

Think of having an independent organization/auditing company/individual who will be dedicated for this exclusive task. Does it not make your task easy and efficient?