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

This online course allows you to gain the necessary knowledge and skills to conduct an internal audit of quality management systems for manufacturers of medical devices (QMS) based on ISO 13485:2016, ISO 19011:2018 standards.

The participants of the training will gain knowledge about the various components of QMS for manufacturers of medical devices, including the following: leadership, risk management, necessary procedures, documentation, performance measurement, management review and continuous development, as well as the tasks and roles of internal auditors in the process of planning and conducting audits, reporting, planning and monitoring of activities and actions based on the results of audits.


36 hours




100% online


• Understand the principles of implementation of QMS for manufacturers of medical devices in accordance with the requirements of ISO 13485

• Get a complete understanding of the concepts, approaches, methods and techniques necessary for the effective management of the QMS

• Gain knowledge in identifying risks and opportunities related to QMS

• Understand the relationship between the QMS and meeting the requirements of the various stakeholders of the organization

• Develop the knowledge and skills needed to advise organizations on best quality management practices for medical device manufacturers and internal audit

• Get familiarized with all the stages of preparing and conducting an internal audit

• Acquire the necessary knowledge to manage a QMS audit team for medical device manufacturers

• Understand the operation of QMS for compliance with ISO 13485

• Improve the ability to analyze the internal and external environment of the organization and decision making in the context of a quality management system for medical device manufacturers

Target audience

• Internal auditors

• Project managers and consultants who wish to learn the quality management system audit process for medical device manufacturers

• Members of the QMS implementation team for medical device manufacturers at the enterprise

• Professionals who want to gain in-depth knowledge of QMS for medical device manufacturers

• Specialists involved in daily support of QMS processes

• Students of specialized faculties

Document on completion

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

Evaluation scale




Does not comply

Thematic plan

The course program includes 2 modules:

1. Quality management system for medical device manufacturers (ISO 13485)

2. Internal audit (ISO 19011)

The program is designed for 36 hours, including time for studying theoretical material and taking tests.


Module 1 Quality Management System for Medical Device Manufacturers (ISO 13485)

Number of hours

1.1 Introduction 1,5
1.2 General provisions of the standard 2
1.3 Organization context 2
1.4 Leadership 2
1.5 Planning 2
1.6 Provision (resource) 1,5
1.7 Functioning 5
1.8 Performance evaluation 2,5
1.9 Improvement 1
  Testing 1
Module 2 Internal audit (ISO 19011)

Number of hours

2.1 Introduction 1
2.2 General provisions of the standard 1,5
2.3 Audit program management 5
2.4 Performing an audit 5
2.5 Auditor competence 2
  Testing 1
Module 1. Detailed content

Introductory part:

–       Introduction

–       History of QMS for manufacturers of medical devices

–       Relationship with ISO 9001


General provisions of the standard:

–       Structure of the standard

–       Elimination of requirements

–       Terminology


Quality Management System:

–       General requirements

–       Documentation requirements


Management Responsibility:

–       Manager commitment

–       Customer orientation

–       Quality policy

–       Planning

–       Responsibility, authority and communication

–       Management review



Resource management:

–       Provision of resources

–       Personnel

–       Infrastructure

–       Working environment


Product creation:

–       Product planning

–       Processes related to the customer

–       Design and development

–       Procurement

–       Realization of production and services

–       Management of monitoring and measurement equipment


Measurement, analysis and improvement:

–       General provisions

–       Monitoring and measurements

–       Management of nonconforming product

–       Data analysis

–       Improvement

Module 2. Detailed content

Introductory part:

–       Audit definition

–       Classification of audits

–       Audit criteria

–       History of the standard


General provisions:

–       Structure of the standard

–       Scope of the standard

–       Terminology

–       Principles

–       Auditor’s Code of Ethics


Audit Program Management (AP):

–       PDCA

–       General provisions

–       Scheme of the AP control process

–       AP planning

–       Identification and assessment of risks and opportunities

–       Person in charge of the AP

–       Determination of the volume of AP

–       AP resources

–       Execution of AP

–       Definition of objectives, scope and criteria for a specific audit

–       Selection and definition of audit methods

–       Selection of members for the audit team

–       AP records management

–       AP monitoring

–       Review and improvement of the audit program

–       Unscheduled audits


Performing an audit:

–       Audit initiation

–       Preparation for the audit, example of an Audit Plan

–       Distribution of tasks in the audit team

–       Preparation of working documents, example of a Checklist

–       Opening meeting

–       Exchange of information during the audit

–       Collection and verification of information: sample questions, spot check

–       Preparation of the Audit Report

–       Preparation of audit conclusions, example of Statement of Nonconformities

–       Closing meeting

–       Preparation and distribution of the Audit Report


Competence of auditors:

–       Stages of competence assessment

–       Personal qualities

–       General knowledge and skills

–       General competence of the audit team leader

–       Maintenance and improvement of the auditor’s competence