Internal auditor ISO 15189:2012

Internal auditor ISO 15189:2012

A quality management system in a medical laboratory should be structurally and periodically reviewed for effectiveness and efficiency. Internal audits are an excellent tool for this and an essential part of a quality management system. In addition, achieving accreditation under the ISO 15189 standard requires a functioning internal auditing system. After completing this internal auditor training programme, you will be able to conduct an effective audit based on the ISO 15189 standard in a structured way, as well as write a professionally substantiated factual report about it.


The goal of the "Internal auditor ISO 15189:2012" training course is:

  • Interpreting and using the ISO 15189:2012 standard correctly as an auditor
  • Conducting internal audits based on the philosophy of ISO 15189:2012
  • Executing audits that are suitable for the laboratory process and ISO 15189:2012.
  • Obtaining the necessary skills to prepare, execute and report audits in a structured way.
  • Being able to use the internal auditing system to maintain the quality management system and as preparation for the external audit


During the training programme, practical examples developed by us will be the starting point. These examples will maximise the effect of learning how to prepare, execute and report an internal audit.
Also, the exercises on interpretation of the standards and a comprehensive explanation of these standards will provide a better understanding of the ISO 15189.
During the presentations and exercises, the experience and skills of the trainers will be made available to the participants.

Target audience

The audit training is for:

  • Quality managers and quality staff who will set up, implement and maintain an internal audit system.
  • Professionals and executives who want to broaden their knowledge of the standard, of the quality management system and its assessment, and possibly conduct internal audits themselves.
  • Other staff that will conduct internal audits.


The following topics will be covered during the training:

  • Structure of a quality management system
  • Interpretation of the ISO 15189:2012 standard
  • Preparing the audit
  • Executing an efficient and effective review and analysis of the quality documentation
  • Making a plan for the site visit
  • Different methods for executing an audit
  • Interview techniques
  • Observation techniques
  • Communication and audit skills
  • Factual reporting

Training and Education

Internal auditor ISO 15189:2012

Kerteza Academy can organise training and education in the way that suits you best.

Internal auditor ISO 15189:2012

We offer instruction and training courses within your own organisation. These are fully customized to your needs.

Practical information: We offer training sessions and courses organised in your own organisation. These are fully tailored to the needs of your organisation. In consultation with you, we will determine which topics are best to focus on during the course. The number of participants, dates and location of the training course are also agreed in consultation. For more information or to request a quote, please fill in our contact form, call or e-mail us.

Certificate: Upon completion of the course, you will receive a certificate of participation based on attendance and active participation.

Syllabus: At the beginning of the course, participants will receive a syllabus containing the programme, background information as reference, the slides to be shown, and exercises.

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