Snežienkova 1/A, 971 01 Prievidza SR
SK
CS
EN

Internal auditor of the quality management system in the field of medical devices according to the requirements of ISO 13485:2016 and ISO 19011:2018 standards

The nearest date: According to you
Venue: Company in-house training
Length: 2 days
Price: On request

Course objectives

  • prepare internal auditors to perform internal audits in organizations,
  • acquaint course participants in detail with the ISO 13485 and ISO 19011 standards requirements,
  • familiarize the technique of internal audits performance in organizations,
  • point out the key problems that internal auditors face in practice and provide possible solutions

Course content

Day 1:

  • Introduction to the quality management systems
  • Requirements of ISO 13485 standard
  • Comparison with the ISO 9001 standard
  • Risk analysis, sterile production, traceability
  • Omission of ISO 9001 requirements according to legal requirements

 

Day 2:

  • Requirements of EN ISO 19011 and audit guidance
  • Requirements for the internal auditor and internal audits
  • Psychological aspects of an audit and effective auditor communication
  • Audit preparation, simulated audit, audit report
  • The most common mistakes of organizations in performing internal audits
     

Additional information

Training Schedule - Open Public Online Term          
Testing the training connection from 07:45 *
Training program 08:00 - 12:00
Lunch break 12:00 - 12:30
Training program 12:30 - 14:00
Processing a case study / test       after 14:00

* UTC +1 time zone (DE, BE, DK, NL, NO, SE, AT, ES, FR, IT, SI, SK, CZ, PL, HU, ...)

Creating a tailor-made corporate course

We can tailor each course to your requirements. For more information please contact us
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offer
+421 908 345 320 Training question

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