Internal auditor of quality management systems for medical device manufacturers (ISO 13485, ISO 19011)

This online course provides the necessary knowledge and skills to conduct internal audits of the Quality Management System (QMS) for Medical Device Manufacturers based on ISO 13485:2016 and ISO 19011:2018 standards.

Participants will gain knowledge into various QMS components, including: leadership, risk management, required procedures, documentation, performance measurement, management analysis and continuous improvement, roles and responsibilities of internal auditors in planning and conducting audits, reporting, planning and monitoring of actions and measures based on audit results.

To enhance understanding, all course slides are voiced. Real-life cases will help participants better apply theory in practice. Structured information is divided into modules, making the learning process even more efficient.

In accordance with ISO 13485:2016 requirements, every company engaged in the production of medical devices is obligated to conduct regular internal audits to ensure product quality and safety. The presence of a qualified internal auditor is crucial to comply with these requirements and maintain the quality management system.

This course is an essenntial step for those aspiring to become highly qualified auditors and make a significant contribution to improving their company’s quality management system.

Course program
Application

Duration

48 hours

Language

English/Ukrainian

Format

100% online

Course objective

The goal of the course ” Internal Auditor of the Quality Management Systems for Medical Device Manufacturers (ISO 13485, ISO 19011)” is to provide participants with the necessary knowledge and skills to conduct internal audits of quality management systems, with a specific focus on medical devices. The course covers the fundamental principles, methods, and tools of auditing, as well as the specific requirements for medical device manufacturers, which are critically important for ensuring the safety and effectiveness of medical devices.

Internal auditors verify whether the quality management system complies with the requirements of the ISO 13485 standard and specific normative requirements for medical devices.

Target audience

  • external auditors of management system certification bodies;
  • lead auditors who are involved in certification, surveillance, and recertification audits;
  • candidates for external auditors who are undergoing training or qualification to work within certification bodies;
  • auditors involved in integrated and combined management system audits.

The course is aimed at professionals who have basic knowledge of management system standards and perform independent, impartial assessments of organizations.

Document on completion

QMS internal auditor certificate for manufacturers of medical devices, listed in the SIC international register

Thematic plan

The course program includes 3 modules:

Module 1 — Quality management system for medical device manufacturers (ISO 13485)
Module 2 — Internal audit (ISO 19011)
Module 3 — ISO 19011:2026 – updates for internal auditors. SIC.MODULE.ISO19011:2026

The program is designed for 48 hours, including time for studying theoretical material and taking tests.

Objectives

Module 1 — Quality management system for medical device manufacturers (ISO 13485)
# Topic Hours
1 ISO 13485 standard: purpose, benefits, terminology 3
2 QMS: processes and documented information 2
3 Management responsibility: policy, planning, analysis 3
4 Resource management 3
5 Product realization and service delivery 4
6 Measurement, analysis, and improvement 2
Test 1
Hours total 18
Module 2 — Internal audit (ISO 19011)
# Topic Hours
1 Audit classification and objectives 3
2 Audit terminology and principles 4
3 Audit program management 3
4 Audit conducting and reporting 4
5 Competence and personal qualities of the auditor 2
Test 1
Case-reviews 1
Hours total 18
Module 3 — ISO 19011:2026 – updates for internal auditors. SIC.MODULE.ISO19011:2026
# Topic Hours
1 Key changes in ISO 19011:2026 for internal audit practice 2
2 Remote audit methods: selection of audit methods, evaluation of audit locations, and on-site auditing 1
3 Audit programme: a risk-based approach 1
4 Audit planning and organization using remote and hybrid audit methods 2
5 Methods for obtaining audit evidence 1,5
6 Evaluation of digital evidence and documented information 1
7 Competence of the internal auditor 1
8 Updating the internal auditor’s working tools 1
9 Case studies 1
10 Testing 0,5
Hours total 12