Equipment is to be calibrated against certified standards having known valid traceability to the National Institute of Standards and Technology or to other nationally recognized standards. Equipment is calibrated, adjusted, and maintained at prescribed intervals. If no nationally- recognized standards exist, the basis for calibration is documented. Records are maintained indicating calibration status. On a basis at a minimum concurrent with major changes in sponsors' quality systems, management sees that the HRC quality system is formally assessed and the results documented.
Management normally uses internal staff to conduct self-assessments.
All HRC activities are subject to planned and scheduled internal and external systems and performance audits to assure that procedures and activities comply with the overall QA Program and to determine their effectiveness. Audits provide an objective evaluation of quality-related practices, procedures, instructions, activities, and items, including the review of documents and records, to insure that the QA Program is effective and implemented properly. Audits are performed in accordance with written procedures, using checklists, by the QA Staff and other appropriately trained personnel as necessary.