See all quality consulting services.
For device manufacturers, compliance with ISO 13485, US FDA, European, Canadian, and Japanese regulations can be challenging; conducting proper internal audits is a big part of maintaining compliance.
Emergo Group specializes in medical device quality assurance and regulatory affairs and can provide on-site Internal Auditor Training to train your employees on how to conduct internal audits of your ISO or GMP (also known as cGMP) quality management system.

Professional, on-site ISO and FDA GMP internal auditor training for one fixed fee, regardless of how many employees attend.
Our internal audit training is based on a set daily fee plus basic travel expenses. This makes it a great value for companies that need to train three or more employees at one time. A senior Emergo Group consultant will lead this GMP & ISO auditor training course on-site at your facility, saving you the time and expense of sending employees elsewhere for training. On-site internal auditor training gives your employees the opportunity to interact.
What your team will learn in this intensive training class
Day 1: Overview of Quality System Requirements
- Overview of ISO 13485:2003, FDA current Good Manufacturing Practices (GMP or cGMP), CE Marking and Canadian Medical Device Regulations (CMDR).
- Management responsibilities to customers, conforming to the quality policy, and to employees.
- Resource management: personnel, materials, infrastructure and facilities.
- Product realization from the planning stages through design development through interaction with customers.
- Ways to measure, evaluate, and improve performance within the organization.
- Requirements for incident reporting, technical files, and risk analysis.
Day 2: Auditing Principles
- Audit planning, preparation, execution, reporting and follow-up
- Audit scope
- How to prepare for an audit
- Stages of the audit process: planning, collecting, meetings, observation, reports and verification
- Collecting objective evidence
- Preparing audit reports and closing audits
Day 3: Mock Audit
- Designed for new auditors
- Mock internal audit of facilities and process
- Application of principles learned on Days 1 and 2 in real-world setting
Please contact us for more information on our FDA GMP and ISO internal auditor training class.
