CCT CCT Quality Management & Documentation 1 — Questions and Answers
Question 1: Which ISO standard specifically governs the competence of testing and calibration laboratories in the US?
- ISO 9001
- ISO/IEC 17025 (Correct answer)
- ISO 14001
- ISO 45001
Correct answer: ISO/IEC 17025
ISO/IEC 17025 is the international standard that specifies requirements for the competence, impartiality, and consistent operation of calibration and testing laboratories.
Question 2: What is the primary purpose of a calibration certificate?
- To record equipment purchase cost
- To document measurement results and traceability to national standards (Correct answer)
- To schedule future maintenance intervals
- To list all personnel who handled the instrument
Correct answer: To document measurement results and traceability to national standards
A calibration certificate documents the measurement results, uncertainty values, and traceability chain linking the calibrated instrument to national or international measurement standards.
Question 3: What does 'traceability' mean in the context of calibration documentation?
- Tracking the physical location of equipment
- An unbroken chain of comparisons to national or international standards (Correct answer)
- Recording who calibrated the instrument
- Logging every time the instrument was used
Correct answer: An unbroken chain of comparisons to national or international standards
Metrological traceability is an unbroken chain of calibrations, each contributing to measurement uncertainty, linking results to recognized measurement standards such as NIST.
Question 4: How often should calibration records be reviewed according to best quality management practices?
- Only when equipment fails
- At defined, regular intervals as specified in the quality management system (Correct answer)
- Every 10 years
- Only when requested by a customer
Correct answer: At defined, regular intervals as specified in the quality management system
Quality management systems require calibration records to be reviewed at defined intervals to ensure ongoing compliance and identify trends or out-of-tolerance conditions.
Question 5: What action must be taken when an instrument is found to be out of tolerance during calibration?
- Immediately discard the instrument
- Initiate a nonconformance report and assess the impact on previous measurements (Correct answer)
- Continue using it until the next scheduled calibration
- Only notify management if requested
Correct answer: Initiate a nonconformance report and assess the impact on previous measurements
An out-of-tolerance finding requires a nonconformance report and a risk assessment to determine if previously made measurements may have been affected.
Question 6: Which document describes the step-by-step process a laboratory uses to perform a specific calibration?
- Calibration certificate
- Measurement uncertainty budget
- Calibration procedure (Correct answer)
- Equipment log
Correct answer: Calibration procedure
A calibration procedure is a controlled document that provides detailed, step-by-step instructions for performing a specific calibration, ensuring consistency and repeatability.
CCT CCT Quality Management & Documentation 1
Which ISO standard specifically governs the competence of testing and calibration laboratories in the US?