Auditor of quality management systems for medical device manufacturers (ISO 13485, ISO 19011, ISO 17021, Rules of SIC)

This online course provides the necessary knowledge and skills for conducting external audits of medical device quality management systems based on ISO 13485:2016, ISO 19011:2018, ISO 17021:2015 standards, and the rules of the System of International Certification (SIC).

Participants will gain knowledge about various components of medical device quality management systems, including leadership, risk management, necessary procedures, documentation, performance measurement, management review, continual improvement, and compliance with regulatory requirements. Additionally, the course covers the tasks and roles of external auditors in planning and conducting audits, reporting, and planning and monitoring actions based on audit results.

Special attention is given to the requirements of ISO 17021, which establishes principles and requirements for the competence, consistency, and impartiality of bodies providing audit and certification of management systems. The course also addresses the rules of the SIC, which help businesses overcome technical barriers in international trade and ensure equal access to global markets.

For better material comprehension, all course slides are narrated. Real-life case studies are provided to help apply theory in practice. The structured information is divided into modules, making the learning process even more effective.

This course is an essential step for those who aspire to become highly qualified external auditors and make a significant contribution to sustainable development.

Course program

Duration

36 hours

Language

English/Ukrainian

Format

100% online

Objectives

• 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 external audit

• Get familiarized with all the stages of preparing and conducting an external 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 external and external environment of the organization and decision making in the context of a quality management system for medical device manufacturers

Target audience

• External 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 External auditor certificate for manufacturers of medical devices, listed in the SIC international register

Thematic plan

The course program includes 2 modules:

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

2. External audit (ISO 19011)

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

Objectives

Auditor of the Quality Management Systems for Medical Device Manufacturers (ISO 13485, ISO 19011)

hours

І module Quality management systems ISO 13485

18

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

ІІ module The procedure for conducting audits ISO 19011, ISO/IEC 17021, SIC Rules

32

1

SIC — an international association of certification bodies

1

2

Audit: objectives and criteria

2

3

Classification of audits and related standards

2

4

Terms and definitions

1

5

Audit principles and their practical implementation

4

6

Attestation procedure, requirements for auditors

4

7

Pre-certification measures and sampling application

4

8

Audit planning

2

9

Primary certification: I and II stages of the audit

2

10

Audit conducting

2

11

Certification decision

2

12

Support: supervisory and special audits, recertification

1

13

Suspension, cancellation, reduction of certification scope

1

14

Appeals and claims

1

 

Test

1

 

Case-reviews

2