In any quality-driven environment, measurement traceability is not optional – it’s expected. Whether guided by external regulators or internal standards, laboratories must be able to demonstrate that instruments used to generate results were fit for their intended use. This assurance begins with calibration.
Calibration connects laboratory results to international reference systems, such as SI, ensuring results are traceable and accurate. It’s a cornerstone of compliance across a wide range of sectors:
Good Manufacturing Practice (GMP) – ensures that quality is built into the manufacturing process. Calibration ensures that instruments meet performance expectations and that data meet ALCOA++ principles
OECD Principles of Good Laboratory Practice (GLP) – mandates that all equipment used in studies be calibrated, inspected, and maintained according to written procedures.
ISO/IEC 17025– defines the competence of testing and calibration laboratories across industries. It requires that calibration be performed using traceable standards, and that the provider is accredited to perform those services. This ensures both the validity of results and the competence of the service provider.
ISO 22000, IFS, and BRCGS – food standards ensure the safety of products through validated monitoring procedures. Calibrated instruments are required for monitoring critical control points and proving product safety throughout the supply chain.
Pharmacopoeias (USP, Ph.EUR., JP, etc.) – laboratories involved in quality control, drug development, or release testing must follow methods that reference require calibrated instruments, often with specific tolerances and traceability expectations.
Even in academic and industrial research, calibration is important. As large corporations increasingly outsource testing or co-develop products with universities, these academic institutions must meet the same traceability and documentation standards as their industry counterparts. Whether generating data for regulatory filings, product development, or peer-reviewed research, institutions must prove that results are reproducible, valid, and measured by calibrated instruments.
Calibration isn’t just about passing audits - it’s about ensuring that what you measure today can be trusted tomorrow, in another lab, or in front of a regulatory authority.