ISO Standards and Laboratory Regulations Quiz
- It is up to the laboratory to design internal quality control systems.
Correct Answer: True. Laboratories must establish systems to verify attainment of the intended quality of results.
- The only sources that contribute to uncertainty of lab results are sampling, calibrators, and environmental conditions.
Correct Answer: False. Other sources may include sample preparation, sample portion selection, reference materials, input quantities, equipment used, condition of the sample, and changes of operator.
- At any time, upon request, the lab must make its list of current examination procedures available to users of laboratory services.
Correct Answer: True. Procedures lists should include primary sample requirements and relevant performance specifications and requirements.
- The lab can determine its own methods for disposal of samples that are no longer required for examination.
Correct Answer: False. Safe disposal of samples that are no longer required for examination must be carried out in accordance with local regulations or recommendations for waste management.
- ISO standards for medical laboratories will never change.
Correct Answer: False. All ISO standards are reviewed at least every five years after their publication. Our technical experts then decide whether the standard is still valid, or whether it should be withdrawn or updated.
- The laboratory must establish the number, type, and frequency of testing control materials used to monitor the complete analytical process.
Correct Answer: True. The testing must detect immediate errors and must monitor, over time, the accuracy and precision of test performance.
- The basic QC requirement is to perform 3 levels of external QC materials testing on each day of testing.
Correct Answer: False. The minimum requirement is to perform 2 levels of external QC materials testing daily, unless performing an Equivalent Quality Control (EQC) option, as listed in the guidelines.