Medical Device Internal Auditor Training for ISO 13485 & FDA QSR

For device manufacturers, compliance with ISO 13485, US FDA, Brazilian, European, Canadian, Korean, and Japanese regulations can be challenging; conducting proper internal audits is a big part of maintaining compliance.

Emergo specializes in medical device quality assurance and regulatory affairs and can provide on-site Internal Auditor Training to educate your employees on how to conduct internal audits of your ISO or GMP (also known as cGMP) quality management system.

Interested in upgrading to ISO 13485:2016? See how we can help.

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. An Emergo consultant will lead this GMP and 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, FDA 21 CFR Part 820 Quality System Regulation, European CE Marking, and Canadian Medical Device Regulations, as needed.
  • Management responsibilities to customers and 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: QMS Auditing Principles

  • Overview of ISO 19011 and how it applies to QMS compliance for medical device companies.
  • Audit planning, preparation, execution, reporting, and follow-up.
  • Audit scope and audit criteria.
  • 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: QMS Mock Audit

  • This training is designed for new auditors.
  • Mock internal audit of facilities and process.
  • Application of principles learned on Days 1 and 2 in a real-world setting.

Please contact us for more information on our QMS internal auditor training class.

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