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Module 1 of 5 · ISO 15189 · Section 1

General requirements

ISO 15189 puts the patient front and center from the first requirement: confidentiality of their clinical data and impartiality in every result.

Content reviewed on

Patient ethics and confidentiality

Protecting the patient's clinical information at every stage, with access restricted by role.

Impartiality

Identifying impartiality risks and separating commercial interests from technical decisions.

Patient-focused care

Considering the needs of the patient and the requesting clinician when designing laboratory services.

What an auditor usually asks for

  • A clinical data confidentiality procedure
  • Patient data access restricted by profile
  • An impartiality risk register
  • Evidence of patient-focused care

How to cover general requirements in Kimobox

  1. 1Set up access to clinical data by user profile in Kimobox.
  2. 2Document the confidentiality procedure as a controlled document.
  3. 3Log the lab's impartiality risk analysis.

Access to clinical data stays restricted by profile, with a log of who viewed each report.

See Kimobox's quality portal

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

  1. ISO 15189:2022 — Medical laboratories. Requirements for quality and competence ISO · December 2022
  2. ISO/IEC 17025:2017 — Competence of testing and calibration laboratories ISO/IEC · November 2017
  3. Entidad Nacional de Acreditacion ENAC · Official portal
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