ISO 15185 Medical Standards Quiz

ISO Overview

• ISO signifies a requirement that organizations must meet to ensure consistent quality and safety in products and services.

Competence

• Competence is defined as the demonstrated ability to apply knowledge and skills effectively to achieve desired outcomes.

ISO 15185

• ISO 15185, currently in its fourth edition as of 2022, focuses on standardizing practices within medical laboratories.
• The scope includes guidelines relevant to both laboratory users and associated companies.

Metrological Traceability

• Metrological traceability refers to the property of a measurement result, linking it to specified reference standards, ensuring accuracy and reliability.

Equipment and Calibration

• Laboratories must ensure equipment conforms to specified acceptability standards and maintain proper calibration procedures.
• Records must be kept for every piece of equipment essential for influencing activity results, including details on manufacture, suppliers, software, and firmware.

Policies and Procedures

• Policies represent a systematic set of guidelines for decision-making and management facilitation within the laboratory.
• Procedures must clearly outline the steps needed to ensure compliance with ISO standards and operational effectiveness.

Record Maintenance

• Each piece of equipment influencing results must have a maintained record that includes:
  • Manufacture and supplier details, software and firmware identification
  • Evidence of acceptance testing and interim findings
  • Records updated and approved following modifications or failures

Technical Measurement

• Technical measurements are crucial for ensuring that the equipment used is accurate and fulfills the necessary standards.

Impartiality and Confidentiality

• Laboratories must uphold impartiality in their testing processes to ensure unbiased results.
• Confidentiality is vital; there should be channels for individuals to report laboratory activities without fear of repercussion.

Authority in Laboratories

• Clear authority structures must be in place within laboratories to enforce regulations and maintain quality control.

Test your understanding of ISO 15185 and its requirements for medical laboratory users. This quiz covers key aspects such as competence, metrological traceability, and equipment calibration. See how well you grasp the essential standards set by the International Organization for Standardization.