CALIBRATION SERVICE Clause Samples
The Calibration Service clause defines the obligations and procedures related to the calibration of equipment or instruments provided under the agreement. Typically, it outlines the frequency, standards, and methods by which calibration must be performed, and may specify whether the service provider or the client is responsible for arranging and paying for calibration. This clause ensures that all relevant equipment remains accurate and compliant with industry or regulatory standards, thereby minimizing errors and maintaining the reliability of measurements or processes.
CALIBRATION SERVICE. Suppliers of calibration services shall maintain a Quality Management System in accordance with any of the following standards, ANZI/NCSL Z540, ISO/IEC 17025, ISO 10012-1, FDA/CGMP/GLP, 10CFR50 Appendix B and must be traceable to NIST (National Institute of Standards and Technology).
16.13.1 All measurement standards shall be traceable and supported by certificates, reports or data sheets including identification of the item; the calibration source; date of calibration; calibration assigned value; Statement of Uncertainty and Environmental or other conditions under which the calibration results were obtained. Supplier to provide a report including a description of the item, calibration interval, date calibrated, identification of the measurement standard, calibration procedure, calibration results and calibration actions taken. Supplier to affix a label to each item calibrated indicating the date calibrated, the next calibration due date and the person performing the calibration.
16.13.2 Individuals that perform product verification / inspect activities shall pass an annual eye examination, administered by a medically qualified person, for near vision and a one-time only examination for color perception test. Individuals must meet the following minimum requirements in one eye, corrected or uncorrected:
16.13.2.1 Near Vision: Snellen 14/18 or better, ▇▇▇▇▇▇ type 2 - 20/25, Ortho-Rated or equivalent method
16.13.2.2 Color Vision: Passing using one of the following methods: Pseudochromatic plates, Dvorine, Ishihara, Richmond, ▇▇▇▇▇▇▇▇▇▇ lantern, Keystone Orthoscope, Titmus Vision Tester, Titmus II Vision Tester
16.13.2.3 Maintain records of vision standards for the period that the relevant employee remains within the supplier’s organization, plus three (3) years.
CALIBRATION SERVICE. Seller will ensure that its equipment is calibrated to the industry standard or manufacture specification. Seller must comply with ANSI Z540 or equivalent standard. A Certificate of Calibration is required that is traceable to NIST or other national measureable standards. Calibration frequency is annual unless otherwise specified.