ISO 13485 quality management system certification for medical device manufacturing.

ISO certified quality management systems for the medical device manufacturing community.

"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." - ISO.ORG

ISO for Medical Part Producers

ISO 13485 vs ISO 9001

ISO 13485, the quality management standard for medical parts.

ISO 13485 is a quality management system standard for manufacturers of medical devices. It's very similar to ISO 9001, but imposes stricter controls and documentation requirements. Both ISO 9001 and ISO 13845 contain the same clauses with mostly the same requirements, but there are several notable differences:

ISO 9001 ISO 13485
Emphasizes: Customer satisfaction Regulatory requirements
Requires: Continuous QMS improvement Maintaining QMS effectiveness
Supports: Flexibility Additional conformance measures

ISO 13485 Certification

If your product includes medical devices or components used by medical device manufacturers, ISO 13485 certification will place you in an elite class of suppliers. Contact us if you're interested in becoming ISO 13485 certified.

ISO 9001 Tools

The following tools are designed for beginners to implement ISO 9001 on their own.

  • This guide offers high level instructions for becoming ISO 9001 certified. Request a free copy.
  • Should be Empty: