Why The FDA General Calibration Requirements Are Not Enough

By Jeremy Kraft, Sr. Manager, Metrology

Calibration and metrology processes are crucial for accurate measurements and safety systems. Failure to perform these processes correctly can have significant consequences, as demonstrated by a real-world example of a worker adjusting a panel meter post-calibration. While highly regulated industries like automotive, food, drug, and medical device sectors have specific regulations around calibration, many other industries treat it as a maintenance task rather than addressing production risks. Ensuring measurement accuracy is vital, and ISO 17025 provides guidelines for proficiency testing to mitigate unknowns in the measurement process. While the FDA does not address measurement uncertainty, it is a critical aspect of calibration. Customers often seek guidance on calibration test points, tolerances, and intervals, and adopting an ISO 17025 accredited calibration company or system can provide those answers.

Calibration is a niche industry that is not well understood by many. With labor shortages and a lack of knowledgeable auditors, it can be challenging for companies to ensure the accuracy of their calibration technicians. Accrediting bodies such as A2LA, ANAB, and NVLAP employ auditors who are knowledgeable in calibration and can provide reassurance that the calibration services meet industry requirements. Many medical companies recognize ISO 17025 accreditation to improve their quality processes. By choosing an ISO 17025 accredited organization, companies can benefit from external auditing and adherence to internationally accepted standards.