Calibration Standards & Regulations Flashcards
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Read the first 7 Calibration Standards & Regulations flashcards as text
Which US federal regulation requires calibration control systems for contractors supplying measurement equipment to the Department of Defense?
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was the US DoD standard requiring contractors to establish and maintain calibration systems; it has largely been superseded by ISO/IEC 17025 but remains a historical reference.
What does the term 'metrological confirmation' mean in ISO 10012?
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.
Which international organization is responsible for defining the International System of Units (SI)?
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.
What is the purpose of an interlaboratory comparison (ILC) in the context of calibration quality?
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.
Under ISO/IEC 17025:2017, how long must a calibration laboratory retain records of calibration results?
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.
What is 'calibration status' and how is it typically communicated on calibrated equipment?
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.
In regulated industries like pharmaceutical manufacturing, which regulation requires that instruments used in testing be calibrated against certified standards?
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.