Bio Calibration Company, Inc

Accredited Labs for Calibration Services versus Non-Accredited

 

Why outsourcing lab calibration services to an ISO/IEC 17025:2017 accredited lab is so important.

When outsourcing your pipette and other lab equipment calibrations, it’s essential to know the qualifications of the vendor you choose to do the work. A great way to take a lot of work out of lab calibration vendor qualifications is to use ISO/IEC 17025:2017 accredited calibration labs.

What exactly is an ISO/IEC 17025:2017 accredited calibration lab?

For a calibration lab to have an ISO/IEC 17025:2017 accreditation, the lab must have met the requirements detailed in the ISO/IEC 17025:2017 standard. An accreditation company is a company that is qualified to determine if labs meet the requirements of the ISO/IEC 17025:2017 standard. The accreditation company sends an auditor to the laboratory to perform a surveillance audit and award the lab accreditation status. An example of an accreditation company is PJLA: https://www.pjlabs.com/accreditation-programs/isoiec-17025.

The next thing to think about is how to tell if a laboratory is ISO/IEC 17025:2017 accredited or not. An easy way to verify this is to ask the laboratory. If they are accredited, it’s a good idea to ask them to provide a copy of their ISO/IEC 17025:2017 accreditation certificate. This document will prove the lab is in good standing with the accreditation company, meaning that they have passed their most recent surveillance audit and the certificate hasn’t expired. The other thing to ask them for is their scope of accreditation. This document will list all the measurements and ranges for which they have been audited and accredited. The reason to ask for the scope and the certificate is to make sure the lab is accredited and that the pipettes or laboratory equipment being sent to them for calibration is within their scope of accreditation.

 

Another question is how to tell if a pipette calibration that has already been outsourced is an actual accredited pipette calibration. If a 3rd party has already calibrated the pipettes or laboratory equipment, the calibration certificate is the easiest way to tell if the calibration was an accredited ISO/IEC 17025:2017 calibration. If the pipette calibration were ISO/IEC 17025:2017 accredited, the calibration certificate would indicate by having:

  1. The accreditation company logo
  2. The lab’s certificate number (usually under the logo)
  3. Date the certificate was issued to the lab
  4. Have the results of the measurement and the uncertainty of measurement reported (if the uncertainty isn’t reported, there will still be a statement that the uncertainty was considered)
  5. A statement of conformity

There are other requirements for ISO/IEC 17025:2017 accredited pipette calibration certificates; however, the ones above are a quick way to check whether the pipette calibration was accredited or non-accredited.

Why is outsourcing to an ISO/IEC 17025:2017 accredited lab so important?

Outsourcing to an ISO/IEC 17025:2017 accredited lab is important because they are required to meet the quality and technical requirements included in the ISO/IEC 17025:2017 standard. First, the lab is required to have Quality Management System and personnel to maintain and continuously improve the Quality Management System. The ISO/IEC 17025:2017 standard has many quality requirements, but here are some things that you will know your accredited lab will have:

      1. Yearly Audits
        An ISO/IEC 17025:2017 accredited laboratory is required to perform at least two annual audits. One of the audits will be conducted by the accreditation company (also known as the assessor audit). The assessor audit is completed to renew the laboratory’s ISO/IEC 17025:2017 certificate. The assessor makes sure the lab meets the requirements of the standard. It is good to know if you are outsourcing your pipette calibrations because you see the lab has a quality management system in place and is required to prove they use it every year.The second audit the laboratory is required to perform is an internal audit. This audit is an ISO/IEC 17025:2017 requirement that all labs have an internal audit program in place. The standard requires this because internal and assessor audits promote continuous improvement and help ensure consistency of testing results. One way that audits promote continuous improvement is that when a nonconformance is found, the lab must take corrective action to prevent the re-occurrence of that nonconformance.
      2. Non-Conformances and Corrective Actions:
        An accredited lab will be required to have procedures for identifying nonconformances and completing corrective actions to prevent nonconformances. Nonconformances are the results of laboratory activities that do not conform to the lab’s written procedures or policies or when the results do not conform to specific agreements made with the customer.When a lab encounters a nonconformance, it starts a corrective action. A corrective action is a process that includes identifying/reacting to the nonconformity, evaluating and determining the cause of the nonconformity, taking action to correct it, reviewing the effectiveness of the actions taken, and making necessary changes to the quality management system.Laboratories need to have procedures for nonconforming work and procedures to identify the causes of the nonconforming work and correct it. When you use an accredited laboratory for your pipette calibrations, you can take solace in the fact that that lab must have and follow these procedures.
      3. Training of Laboratory Personnel:
        An accredited lab is required to ensure that its personnel are competent to perform all activities and can evaluate the significance of deviations that may occur during laboratory activities. When accredited labs are audited by their assessors, they are asked to provide evidence for the competency of their employees. Having trained personnel is another advantage to outsourcing your pipette calibrations to an ISO/IEC 17025:2017 accredited laboratory. 
      4. Seeking Customer Feedback:
        One of the most important things to do for continuous improvement is to seek customer feedback and ask about their experience. Feedback is a great reason to choose an ISO/IEC 17025:2017 accredited company to outsource your pipette calibrations. The company must seek customer feedback and include it in its management review meetings to determine if it warrants corrective action or changes to the quality management system.

      5. Many other Quality Requirements:
        To maintain its accredited status, a lab must meet many other requirements. These additional requirements help ensure the reliability and validity of the lab’s results.

The lab is also required to meet specific technical requirements. These technical requirements are put in the ISO/IEC 17025:2017 standard so that labs ensure the accuracy and consistency of their measurement results. Like the quality requirements, the standard has many technical requirements, but here are some things you will know your accredited lab has procedures for:

  • Scope of Accreditation – CMC
    When a lab is awarded an ISO/IEC 17025:2017 accreditation, it must have a documented list of all its measurement capabilities and associated uncertainties. This is called their scope of accreditation. This document is always available on a lab’s website when ISO/IEC 17025:2017 accredited. However, you can also ask an accredited lab for this document as well.
  • Proficiency Testing
    All ISO/IEC 17025:2017 accredited labs must complete proficiency tests. Proficiency tests require a lab to calibrate or measure a 3rd party companies’ equipment (or artifact). The artifact is measured by numerous labs. When all the labs participating in the proficiency test have completed their measurements, the 3rd party company compares all the labs’ results to make sure they agree with each other. Proficiency testing is another good reason that outsourcing to an accredited lab is such a good idea.
  • Calibration Reports
    Accredited labs are required to put certain information on their calibration reports. If a lab is ISO/IEC 17025:2017 accredited, its calibration reports must have all the information that the standard requires. There are a lot of calibration report requirements. Some examples include the location and environmental conditions of the calibration, the unique identification of all the standards used in the calibration, and the methods used to calibrate the equipment. If you were to use a non-accredited lab, it’s possible that some critical information would be left off the calibration report.
  • Uncertainty of Measurement and Decision Rules
    The ISO/IEC 17025:2017 standard requires the lab to define a decision rule that describes how the uncertainty of measurement is considered when making statements of conformity. The standard also requires the lab to have an uncertainty budget for its calibration methods. An uncertainty budget is a good thing to know about accredited labs because it is basically a summary of all the possible errors and how they can possibly affect the measurement or pipette calibration results. Non-accredited labs are not required to consider all these errors.

Conclusion

When outsourcing pipette calibrations, it’s essential to understand the difference between an ISO/IEC 17025:2017 accredited and a non-accredited laboratory. Using an ISO/IEC 17025:2017 accredited laboratory will ensure that your pipette calibrations are being performed by someone who must meet the requirements of the ISO/IEC 17025:2017 standards. The accredited laboratories will have to participate in yearly audits to prove that they are still meeting the quality and technical requirements of the standard.

Bio Calibration company is an ISO/IEC 17025:2017 accredited laboratory. We passed our most recent surveillance audit with zero findings. Here is a link to our scope of accreditation.

Are you currently using an accredited laboratory to calibrate your pipettes? Learn how Bio Calibration Company can start providing your organization with accredited pipette calibration services.

 

Accredited Labs for Calibration Services versus Non-Accredited