ISO 13485Mapped to the CQI / IRCA Lead Auditor syllabus

ISO 13485 Lead Auditor

Lead auditor training built to the CQI / IRCA syllabus

4 Days Professional Training Program
Gloved technician assembling a medical device in a cleanroom
Course Overview

Next Batch

We don't have a public batch open for this course right now. We run it on demand and as private group training at your premises or online.

Executive Focus & Programmatic Intent

Medical-device quality is high-stakes and heavily regulated. This course trains you to audit the system that keeps devices safe and compliant.

Target Operational Competencies

Medical-device quality managers.
Regulatory affairs staff.
Device auditors.

Course Syllabus

Module 1: Device QMS
•Understand ISO 13485 scope.
•Review regulatory links.

Mandatory Entry Gate Criteria

Bring the basics with you. The course moves fast on day one, so candidates who already meet the points below get the most out of it.

[!]ISO 9001 awareness helpful.

Your Certificate

Complete the course and pass the end-of-course assessment and RSI issues your training certificate, carrying a unique number you or any employer can verify on this site for life. Where the course maps to an external awarding body's qualification, you hold that qualification by sitting that body's own examination — this course is built to prepare you for it.

Issued by:RSI Academy
Schedule

Available Batches

No public batches scheduled yet — this course runs on demand and as private group training.
STATUS:Next batch on request