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EN ISO 15189 (as an audit objective within the scope of ISO 9001 audits)

Motivation and benefits

Medical laboratories are of crucial importance for patients care and their services need to comply with high quality standards. EN ISO 15189 creates a best practice model which enables medical laboratories to display competencies in a consistent and transparent way.

It requires a quality management system based upon ISO 9001.

For more information please refer to the German version or contact us!


For more information regarding the accreditation and your options, please refer to the German version or contact us!

  • ensuring quality of results and best practice
  • increasing of competence
Target group

Any medical laboratories, including pathological laboratories

  • requirements placed on a quality management system and demonstrating that these requirements are met;
  • technical requirements and equipment
Other relevant standards

ISO 9001

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