ISO 15189 and ISO/IEC 17025.

MQ Consulting supports laboratories in preparing and maintaining systems aligned with accreditation requirements, including documentation, traceability, method validation, equipment and technical competence.

Quality in healthcare · ISO 15189

ISO 15189 specifies requirements for quality and competence in medical laboratories. Reliable analytical results depend on consistent practices throughout the laboratory process, from sample management to the review and communication of results.

Preparing for accreditation connects management requirements and technical competence: responsibilities, staff competence, suitable methods, quality control and evidence of implementation.

Testing and calibration laboratories · ISO/IEC 17025

ISO/IEC 17025 specifies requirements for the competence, impartiality and consistent operation of testing and calibration laboratories. The applicable standard depends on the laboratory's activities; it does not automatically replace ISO 15189 in a medical setting.

Implementation covers methods, equipment, metrological traceability of measurement results, measurement uncertainty where applicable and ensuring the validity of results. Accreditation can support international recognition within the accredited scope and applicable recognition arrangements.

Managing laboratory risks

Risk management translates into controls and records suited to the activities, methods and consequences of a failure.

• Samples: identification, collection or sampling conditions, transport, reception, storage and traceability, as applicable.
• Equipment: fitness for use, maintenance, calibration and verification planning where applicable, acceptance criteria, review of results and handling of deviations.
• Processes: staff competence, quality control, nonconforming work and follow-up of improvement actions.

How MQ Consulting supports your laboratory

MQ Consulting supports gap assessment, planning and implementation of practices aligned with the applicable standard, as well as preparation and follow-up for accreditation. The work is adapted to the laboratory's activities and intended scope.

MQ Consulting's support is not an accreditation decision. Assessment and accreditation decisions belong to the accreditation body, for a defined scope. Equipment management support does not constitute the provision of calibration services.