What is calibration? Calibration is the verification of a product’s specified accuracy.
What are the basic types of calibration?
Batch – one device is picked from a manufactured lot and tested to confirm the entire batch meets specifications. This can potentially send a defective product into the market.
Individual – every device is tested and calibrated to ensure you are getting a complete working product, not a defective one.
Accredited – each individual device is calibrated in accordance with a quality standard—usually ISO/IEC 17025 for testing and calibration laboratories. Additionally, the calibration has been reviewed and certified by a third-party, ILAC-certified accreditation body (i.e., A2LA, NAVLAP, ANAB, etc.). This type of calibration offers the highest level of certainty that the device is accurate and reliable to use.
Why should I get my device calibrated? Calibration ensures the data output from your device is providing accurate, repeatable measurements right out of the box. This allows you to rule out a defective device that could potentially cause production delays, product defects, and recalls. It also allows you to meet quality systems and comply with industry standards such as ISO, FDA, USDA, EPA, GLPs/cGMPs and other quality standards.
How often should my device be calibrated? We recommend devices be calibrated annually. However, your quality system, conditions of use, and performance may warrant more frequent calibration such as sensitive applications requiring high device accuracy or less infrequent depending on your need. If you are unsure, follow the manufacturer’s instructions for your device as an initial calibration point.
Why trust Cole-Parmer for calibration?
In-house A2LA-accredited laboratories complying with International Standards in accordance with ISO 9001, ISO/IEC 17025 to help customers meet ISO, EPA, GLPs/cGMPs, FDA compliance, and other quality standards.
Metrology labs can calibrate new or existing instrument using standards traceable through NIST and provide a document of certification (if required).
Excellent value—our NIST-traceable reports offer extensive test data on a broad range of measurement parameters at an affordable price. (can list parameters or link to documents)
What is precalibration (initial calibration)? Newly purchased items are calibrated, by either our Traceable® or InnoCal® accredited metrology laboratories, before the product ships. Simply add calibration service to your order or select products marked with the Traceable brand name. Once your item arrives, it is certified to NIST-traceable standards and ready to use right out of the box.
What is recalibration? When you send your existing device for calibration on a regularly-scheduled basis to make sure your product is always in compliance. The frequency of recalibration will depend on your quality system or usage conditions.
How do I know if I should recalibrate or replace? Recalibrate if its required by a regulatory body or accreditation agency, required by your documented process, the unit or device has a high point price, or you need to document a history of the device’s consistency. Replace if the recalibration cost is significantly higher than the replacement cost, or if you are not required to recalibrate by a regulatory body or accreditation agency, required by your documented process, or you need a documented history of the device’s consistency. Choosing to replace equipment instead of recalibrating can expose your company to risk, if device consistency is critical to your application, since you are not able to confirm that critical measurement equipment maintained its accuracy throughout the full use period. Ultimately, it is the end user’s decision.
What is an A2LA-accredited laboratory? The American Association of Laboratory Accreditation (A2LA) is one of the foremost auditing agencies using the ISO/IEC 17025 standard specifically to assess a laboratory’s ability to provide precise, accurate test and calibration data.
What is ISO 9000? This is the most common quality standard. It is recognized by more than 120 countries. For a company, having a quality program in place that adheres to ISO 9000 standards only assures that the company monitors and tracks its work to meet customer needs.
What is ISO/IEC 17025? The 17025 standard expands the quality portion of ISO 9000 to specifically address calibration and testing methods’ quality program—that the company maintains properly calibrated reference standards, and that its measurements can track back to what is called the metrology center in each country. In the US, it’s the National Institute of Standards and Technology (NIST).
What is NIST-traceable calibration? NIST traceable means that the equipment being used to calibrate your product meets NIST standards and has an audit paper trail back to the original equipment used to test to the highest accuracy possible.
What is a NIST-traceable certificate? A calibration certificate that identifies the standards used are traceable through NIST. It is a link in the traceability chain from the customer unit to NIST.