Internal QMS Auditor Training for Medical Device Companies

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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.