CCIL ISO 17025 Quality Management 2 — Questions and Answers
Question 1: Under ISO 17025, what is the primary purpose of an internal audit program?
- To replace external accreditation assessments
- To verify that the laboratory's management system conforms to requirements and is effectively implemented (Correct answer)
- To evaluate customer satisfaction with laboratory services
- To compare performance against competitor laboratories
Correct answer: To verify that the laboratory's management system conforms to requirements and is effectively implemented
Internal audits verify conformance to the management system requirements and effective implementation, not to replace external assessments.
Question 2: When a laboratory identifies a nonconforming piece of work, which action should be taken FIRST?
- Immediately notify the accreditation body
- Stop work and evaluate the significance of the nonconformity (Correct answer)
- Re-run all tests performed that day
- Document the nonconformity in the quality manual
Correct answer: Stop work and evaluate the significance of the nonconformity
The first step is to stop work and evaluate the significance before deciding corrective actions or notifications.
Question 3: ISO 17025 requires that laboratories retain records of original observations. What is the key reason for this requirement?
- To allow billing disputes to be resolved
- To enable reconstruction of the test or calibration if needed (Correct answer)
- To satisfy insurance requirements
- To provide material for staff training
Correct answer: To enable reconstruction of the test or calibration if needed
Retaining original observations allows the laboratory or auditors to reconstruct the test or calibration activity if questions arise.
Question 4: In ISO 17025, what does 'metrological traceability' specifically require?
- Reference to an international measurement standard through an unbroken chain of calibrations (Correct answer)
- Using only NIST-certified equipment
- Purchasing equipment from accredited manufacturers
- Calibrating equipment once every calendar year without exception
Correct answer: Reference to an international measurement standard through an unbroken chain of calibrations
Metrological traceability requires an unbroken chain of calibrations linking measurements to recognized national or international standards.
Question 5: Which of the following scenarios best describes a 'method validation' activity under ISO 17025?
- Reviewing a published standard method before first use
- Confirming that a non-standard method is fit for its intended purpose through experimental testing (Correct answer)
- Calibrating the equipment used in an established standard method
- Obtaining customer approval for the test method to be used
Correct answer: Confirming that a non-standard method is fit for its intended purpose through experimental testing
Method validation involves experimentally confirming that a non-standard or in-house method is fit for its intended purpose.
Question 6: A laboratory uses statistical process control charts to monitor ongoing measurement quality. Under ISO 17025, this practice is classified as:
- Method validation
- Proficiency testing
- Monitoring the validity of results (quality control) (Correct answer)
- Risk management
Correct answer: Monitoring the validity of results (quality control)
Statistical control charts are a quality control technique used to monitor the ongoing validity of test and calibration results.
Question 7: According to ISO 17025, which party is ultimately responsible for ensuring laboratory personnel are competent?
- The accreditation body
- Laboratory management (Correct answer)
- Individual personnel through self-assessment
- The customer commissioning the work
Correct answer: Laboratory management
Laboratory management bears ultimate responsibility for ensuring all personnel who affect laboratory output are competent.
CCIL ISO 17025 Quality Management 2
Under ISO 17025, what is the primary purpose of an internal audit program?