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ISO 15189 (verification within the Scope of the ISO 9001 Audit)


Medical laboratories are of utmost importance for patient care. High quality requirements are placed on their services. ISO 15189 offers a best-practice model that is established worldwide and is to enable medical laboratories to demonstrate their competence in a uniform and transparent manner. ISO 15189 is especially applicable to medical laboratories and is based upon ISO/IEC 17025 and ISO 9001. In the new EU Regulation 2017/746, which deals with in-vitro diagnostic medical devices, the quality level defined by ISO 15189 is prescribed to medical laboratories using in-house products.


On the one hand, the requirements address top management. On the other hand, they refer to technical competence. The objectives and targets of accreditation acc. to ISO 15189 go beyond those of ISO 9001 certification. They are mainly linked to endeavours to ensure quality of results by guaranteeing competence in scientific and technical terms. The goal consists in evidencing competence in the theoretical fundamentals and the practical skills and capabilities, which are necessary to understand the Standard, successfully implement process management and achieve the state of the art when it becomes to providing services in the medical laboratory.


If a medical laboratory has defined ISO 15189 to be an internal requirement for its work, e.g. in connection with a quality management system acc. to ISO 9001, qualityaustria Auditors qualified adequately can additionally audit compliance with this internal specification within the quality management system when providing the relevant qualityaustria auditing services. In conformity to the regulatory requirements, no Certificate will be issued. Instead the audit that has been conducted will be acknowledged by choosing the following text: “Herewith Quality Austria acknowledges that the laboratory has the competence to meet the special requirements placed on quality and competence acc. to EN ISO 15189”. This acknowledgement cannot be equalled to certification or an attestation of conformity and quite obviously is not the same as issuance of an administrative decision in an accreditation procedure either. Issuing such a decision is exclusively reserved to the accreditation bodies legally authorised to do so.


In order to enable preparations for such an accreditation procedure, however, integration of the requirements of ISO 15189 into an ISO 9001 quality management system and external auditing of compliance with these requirements are important steps.


Hint: ISO 15189 is an accreditation standard. Thus conformity and competence can only be stated in the course of verification made by a national accreditation body that is recognised acc. to the EU Regulation 765/2008. Therefore, it should be noted that Quality Austria does not offer any certification relating to this Standard and auditing can only be done in connection with a certifiable Standard, e.g. ISO 9001 or EN 15224.

  • ensuring quality of results and best practice
  • increasing and demonstrating competence

Any medical laboratories, including pathological laboratories

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

ISO 9001


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