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Domaine technique

Laboratoires médicaux

A medical laboratory’s result is used in the care of a person. Competence therefore includes the examination itself and the activities before and after it that determine whether the result can be understood and used.

An analytical laboratory with a row of benchtop instruments
The photograph illustrates the kind of setting associated with this work. It does not show AKZERT staff, AKZERT premises or an accredited body.

ISO 15189

ISO 15189 specifies requirements for quality and competence in medical laboratories. It is the standard ordinarily referred to when accreditation of this work is discussed. It sits alongside, and is distinct from, ISO/IEC 17025, which frames testing and calibration laboratories more generally.

The path of a sample matters. Collection, identification, transport, preparation, examination, validation of the result and the report to the requesting clinician can each affect the information that reaches the patient. A competence attestation that ignored the path would be incomplete.

The scope identifies the examinations, or the fields of examination, for which the laboratory is attested. Medical laboratories often work across disciplines. The scope should allow a reader to see which disciplines and which examinations are covered.

Patient information and clinical samples call for confidentiality and for careful control of records. Those duties sit with the laboratory and with the law that applies to it. This page does not state a medical-device or healthcare authorisation, and it does not describe AKZERT as a health authority.

Points ordinairement examinés

  • Examinations are validated for the intended clinical purpose.
  • Pre-examination and post-examination activities are controlled.
  • Staff competence covers the examinations they perform and authorise.
  • Results are reported in a form that the recipient can interpret.
  • Confidentiality of patient information is maintained.

Questions

Is ISO 15189 the same requirement as ISO/IEC 17025?

Both standards address laboratory competence and a management system. ISO 15189 is written for medical laboratories and gives particular attention to the clinical purpose of the examination and to the path of the sample. A medical laboratory is ordinarily discussed under ISO 15189.

Does accreditation of a medical laboratory authorise clinical practice?

Accreditation, in the sense used on this site, attests competence for defined laboratory activities. Authority to practise a health profession, or to operate a healthcare service, comes from the law that governs that activity. This site does not describe any such authority.