Certificate Summary

ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It 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 and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. This Certification provide learners with the knowledge and skills required to perform first, second and third-party audits of medical device quality management systems against ISO 13485 and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021. Understand the requirements of ISO 13485:2016 to be able to conduct a successful audit. Learn how it compares to 21 CFR 820 and ISO 9001:2015. Conduct practical audit exercises to apply these requirements and manage the audit process in a collaborative and engaging environment.

Structure of the Assessment

Exam Duration and Format

• The total duration of the exam is 1 hour (60 Minutes).

Validity and Renewal

The ISO 13485:2016 - Certified Lead Auditor Certificate is valid for life.

Displaying your certificate

• Remember, when labeling a product or system as certified to an ISO standard:
• Don't say: "ISO certified" or "ISO certification"
• DO say: "ISO 9001:2008 certified" or "ISO 9001:2008 certification" (for example).