In a recent blog post, we covered the importance of calibration for the medical device industry. But an important question remains - what is equipment calibrated against? In order to ensure that equipment is tuned to correct measurements, it is important to calibrate against a set of shared standards. In this blog post we will cover calibration standards and their relationship to regulatory compliance organizations such as ISO and the National Institute of Standards and Technology (NIST).
What is NIST?
The National Institute of Standards and Technology (NIST) is a US government agency that is responsible for developing and maintaining measurement standards, amongst other responsibilities. NIST is a part of the US Department of Commerce with the purpose of enhancing the United States’ industrial and technological competitiveness, innovation, and quality. By developing measurement standards, NIST supports industry deliver consistency, reliability, and compatibility in products. NIST is widely respected and is often referenced in international regulations and compliance standards.
What is ISO?
The International Organization for Standardization (ISO) is an international organization that develops standards for a wide range of industries. These standards focus on quality, safety, efficiency, and interoperability. While NIST is focused specifically on measurement standards, ISO has a broader focus on standards. In particular, ISO 9001 is a well-recognized standard for the process of Quality Management. ISO 9001 helps companies develop internal processes based on acknowledged and proven standards including: Leadership Commitment, Organizational Planning, Operational Control, Product Design and Development, Supplier Control, Performance Evaluation, Identity and Traceability, etc.
How does ISO Relate to NIST and Calibration?
A core component of the ISO 9001 standard is calibrating equipment so that it consistently delivers quality products. Specifically, Section 7.1.5.2 - Measurement Traceability, which states that “measuring equipment shall be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards.” Without naming NIST (because ISO is an international organization and NIST is a US-based organization), ISO is essentially stating that equipment should be calibrated against NIST standards and traceable back to NIST records.
What are NIST Calibration Standards?
NIST Calibration Standards are references to ensure measurement accuracy and consistency in laboratories, manufacturing, healthcare, and other industries. These standards are benchmarks for accurate measurements. When a piece of equipment or a device is calibrated against NIST standards it means that the recognized NIST calibration standard was used to validate the accuracy of your device. If you were to calibrate a device without using a standard, there is no way to ensure that the device was tuned correctly and its measurements may be skewed - causing considerable quality issues down the line.
If a device is calibrated against a NIST standard, you know that the calibration or tuning is accurate against a national standard. An inch means an inch. By aligning with NIST standards, organizations improve product quality, support compliance, and minimize risk associated with inaccurate measurements.
What NIST Measurement Traceability?
Finally, in order to maintain compliance or meet regulatory standards, it is important to prove that equipment and devices were calibrated against NIST standards. This is where Measurement Traceability comes into the picture.
Measurement results during an equipment calibration are reported on calibration certificates. If calibration is NIST Traceable, that means that the measurement results are traceable back to NIST mass standards. NIST defines traceability as a “Property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty.” In simplest terms, the calibration conducted on a device is documented and can be referenced back to a NIST standard.
The Essential Role of Labels in Measurement Traceability
Labels provide clear, accessible, and on-device records that link instruments and measurements back to NIST-certified standards. In fact, labels are so crucial to calibration and measurement traceability that they are specifically mentioned in the FDA’s GMP Standards and ISO 9001:
- GMP Standards 21 CFR Part 820.61 - Measurement Equipment - “calibration date, the calibrator, and the next calibration date shall be displayed…” - this standard requires that any device requiring calibration will be labeled with information regarding the past calibration and future events.
- ISO 9901 Part 4.11 - Inspection, Measuring, and Test Equipment - “Identify, calibrate, and adjust all equipment at prescribed intervals…” This part requires that any equipment used in inspections and measurements are calibrated at regular intervals. In order to ensure that equipment is calibrated within the proper internal, a label can be used to identify the last calibration date and the next scheduled calibration.
If the specific language in regulatory compliance requirements is not enough, here are some reasons why labels a critical for maintaining calibration measurement traceability:
Identification of Calibrated Equipment
A label on an instrument quickly indicates that an instrument has been calibrated and is available for use in manufacturing. Calibration labels include areas to note the calibration date, due date for the next calibration, and the responsible technician.
Clear Documentation for Audits
Calibration Labels or Calibration Tags applied to equipment act as on-equipment records, allowing fast and efficient validation during audits. By including on-equipment calibration records like labels, compliance and verification is simplified.
Date and Certification Tracking
Including a barcode or QR code on a calibration label further enhances the traceability record and operator usability. These codes link the equipment to a digital calibration record in an internal system. This record can include detailed information such as calibration dates, scheduled dates, technician traceability, measurement results, and NIST traceability.
Support Preventive Maintenance Schedules
Calibration labels indicate when recalibration is due, ensuring that regular maintenance is conducted. They can also notify operators that a piece of equipment is Out of Service so that it is not inadvertently used.
Quality Control and Standardization
Consistent labeling practices help organizations maintain standardized calibration procedures across multiple sites or teams. Labeling reinforces adherence to NIST standards organization-wide, promoting measurement reliability and consistency.
Enhanced Reliability in High-Use Environments
High-quality calibration labels or self-laminating tags are designed to withstand harsh environments, ensuring that measurement traceability information remains visible and intact over time, even in settings involving high temperatures, chemicals, or humidity.
Calibration Labels from GMP Labeling
At GMP Labeling, we understand the critical role that calibration plays in the medical device industry. Our calibration labels are designed to help manufacturers meet regulatory requirements and maintain strict quality control standards. Our labels are durable, easy to apply, and customizable to suit specific requirements, ensuring they remain legible even in demanding environments.
Explore our full range of calibration labels and ensure that your equipment is always properly marked, contributing to safer, more efficient, and compliant operations.
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