ISO/IEC 17025:2005 Audit

ECS Metrology, LLC has completed their first ISO/IEC 17025:2005 audit with a scope covering single channel pipettes, multi-channel pipettes, fixed pipette, class 1-4 balances and bench top scales. Along with ISO 17025, ECS will be certified to ISO:9001 standards; a standard that outlines ECS Metrology’s dedication to yearly management and technical reviews.

Our pipette calibration scope, found here, will cover liquid handlers from .5 ul to well over 10000 ul and include both “as-found” and “as-left” data collection.  Along with ECS procedures and ISO 8655 guidelines, ECS will calibrate and service pipettes 5 times at 3 volumes. This Level 3 service will be ISO certified by PJLA. Our extensive calibration procedures and intensive technical system has allowed ECS to perform 5 measurements versus the standard 10 measurement system.  To provide this pipette service, ECS performed validation testing on 5 readings and compared this EN values with 10 readings. Along with internal validation, ECS Metrology was capable of producing interlaboratory comparison pipette values near the top of the study group. The subsequent analysis showed ECS procedures and pipette calibration services to be validated against independent reference values.

Our balance calibration scope will cover balances with divisions as low as 100,000 d.  This 6-place balance calibration service will provide customers with ISO certified calibration certificates, referencing our calibration uncertainty. These uncertainty values are traceable to NIST through the utilization of Class 1 weights and measures. Balances and scales greater than 500 grams will be referenced to NIST Class F weights and measures. Through NIST Class F weights, calculated uncertainties will be greater than that of Class 1 weights.  At first, this may seem unsatisfactory. Upon further review, it becomes clear this is not necessary a detriment to the calibration process. NIST Class F weights are used for balances with a high nominal value and lower resolution. Thus, for low resolution, uncertainties of lower class weights do not have an effect of the viability of the calibration.

ISO accreditation is a time consuming, work filled endeavor. ECS has been working and waiting for pipette and balance accreditation for 9 months. The paperwork alone is enough to make an organization want to quit.  ECS has persevered and made it through the pipette audit, and now we wait.  Expected accreditation date: End of September. Soon we will post our certificate on our website and hang our certificate in our office; but for now, we are back to waiting.

 

Pipette Calibration for the ISO/IEC 17025 Compliant Laboratory

ISO/IEC 17025 is the gold standard for the calibration industry, specifically the pipette calibration service industry. But what does this standard actually cover?  Many questions are asked regarding this standard and many answers are given. Like many things, the answer isn’t as in depth as you may think.

Pipette calibration services vary from company to company and laboratory to laboratory. You may ask yourself: does my laboratory need 3 pipette readings? or 10 pipette readings? How many different calibration points are sufficient?  Do we need uncertainties? If so, are real-time uncertainties required? With so many different pipettes on the market and even more pipette calibration methods, you may not know where to start.  Here is a quick, ISO answer: It is you decision.  Yes.  It is you decision on the level of service you would prefer.  It is your decision on the calibration interval, pipette calibration method, calibration points, calibration company and location (on-site or off-site). As long as the company can supply evidence to the customer of the companies ability to perform compliant calibration, you laboratory will be compliant with GLP, GMP, ISO and FDA standards and procedures.

Selecting a company to perform calibrations can be burdensome.  When selecting a pipette calibration service, ensure the company uses: ASTM NIST traceable weights, 5 place balances for 10 ul pipettes, humidity traps and validated methods and procedures.  If reports are needed, ensure the company reports include the following: Methods, z-factor adjustment, pass/fail criteria, technician signature or initials, a statement of calibration and all pipette information (serial number, manufacturer, etc). Ensure the company can calibrate all types of pipettes such as: electronic, positive displacement and repeater pipettes. For a full list of pipette types and service types, you can visit www.ecs-metrology.com.

Laboratories and their manages who follow the above recommendations can rest easy and be sure they are ISO complaint.  Pipette calibration should be the least of your worries, focusing your energy for the real reason you work in the biotech or health industry; research and improvement