CCT Calibration Standards & Regulations 4 — Questions and Answers
Question 1: Which US federal regulation requires calibration control systems for contractors supplying measurement equipment to the Department of Defense?
- 10 CFR Part 50
- MIL-STD-45662A (Correct answer)
- OSHA 29 CFR 1910
- 49 CFR Part 40
Correct answer: MIL-STD-45662A
MIL-STD-45662A was the US DoD standard requiring contractors to establish and maintain calibration systems; it has largely been superseded by ISO/IEC 17025 but remains a historical reference.
Question 2: What does the term 'metrological confirmation' mean in ISO 10012?
- The process of confirming a laboratory's accreditation status
- A set of operations required to ensure measuring equipment conforms to requirements for its intended use (Correct answer)
- The approval of calibration certificates by a national body
- The verification that calibration intervals are appropriate
Correct answer: A set of operations required to ensure measuring equipment conforms to requirements for its intended use
ISO 10012 defines metrological confirmation as the set of operations needed to ensure measuring equipment meets requirements for its intended use, including calibration and any necessary adjustment.
Question 3: Which international organization is responsible for defining the International System of Units (SI)?
- ISO
- BIPM (Correct answer)
- ILAC
- NIST
Correct answer: BIPM
The Bureau International des Poids et Mesures (BIPM) is the intergovernmental organization responsible for maintaining the International System of Units (SI) and international measurement standards.
Question 4: What is the purpose of an interlaboratory comparison (ILC) in the context of calibration quality?
- To rank laboratories by their equipment cost
- To evaluate laboratory performance by comparing measurement results against other laboratories (Correct answer)
- To satisfy ISO 9001 audit requirements
- To establish calibration intervals for reference standards
Correct answer: To evaluate laboratory performance by comparing measurement results against other laboratories
Interlaboratory comparisons allow laboratories to assess their measurement performance and identify biases by comparing results with other participating laboratories.
Question 5: Under ISO/IEC 17025:2017, how long must a calibration laboratory retain records of calibration results?
- 1 year
- 3 years
- At least the duration specified in contractual or regulatory requirements, minimum defined by the lab's own policy (Correct answer)
- 10 years minimum
Correct answer: At least the duration specified in contractual or regulatory requirements, minimum defined by the lab's own policy
ISO/IEC 17025:2017 requires laboratories to define a record retention period that meets applicable regulations and contractual requirements, with no single universal minimum specified in the standard itself.
Question 6: What is 'calibration status' and how is it typically communicated on calibrated equipment?
- The pass/fail result printed on the test report only
- An indication (usually a label or tag) showing the calibration date, due date, and calibrating lab (Correct answer)
- A digital entry in the national calibration database
- A color-coded sticker mandated by NIST
Correct answer: An indication (usually a label or tag) showing the calibration date, due date, and calibrating lab
Calibration status is typically communicated via a label or tag affixed to the equipment showing the calibration date, next due date, calibrating technician or lab, and sometimes the certificate number.
Question 7: In regulated industries like pharmaceutical manufacturing, which regulation requires that instruments used in testing be calibrated against certified standards?
- FDA 21 CFR Part 11
- FDA 21 CFR Part 211 (Correct answer)
- EPA 40 CFR Part 136
- OSHA 29 CFR 1926
Correct answer: FDA 21 CFR Part 211
FDA 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals) requires that laboratory instruments be calibrated against standards with known accuracy.
CCT Calibration Standards & Regulations 4
Which US federal regulation requires calibration control systems for contractors supplying measurement equipment to the Department of Defense?