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ISO/IEC 17025 – LMS

Laboratory Management System — For Testing and Calibration Labs

ISO/IEC 17025
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ISO/IEC 17025

Laboratories and analytics-based businesses around the world know about the ISO/IEC 17025 standard. This standard deals with the regulations for the competence of testing and calibration in laboratories . Organizations that have laboratories and even those that deal with third-party labs can benefit from implementing this standard. Focused on testing and calibration, businesses that want their services to stand out can rely on the seal of approval that ISO/IEC 17025 compliance offers to their business processes. 

The overall management system of a lab like quality, administration, technical operations (testing, calibration, sampling, and inspection) can be established with the right implementation of ISO 17025 standard. Having set parameters for a lab operation can make your organization stand out from the crowd.

Why Choose ISO/IEC 17025? 

Management systems within a lab need to adhere to strict guidelines. The standard establishes the procedures for administration, technical competence, and the quality of results. By implementing the standard, a lab can clearly define objectives for the staff to work towards ensuring process improvement. Not only does it improve the efficiency of these processes, but it also allows the company to stand out from its competition. 

Both companies that deliver third-party lab results and departments within larger corporations can benefit from ISO/IEC 17025 compliance. Accreditation allows these labs to state that their processes are in keeping with international standards. Thanks to its flexibility, the standard has been adopted in both private industry as well as government laboratories to establish their operating guidelines and what they expect from their processes. By adhering to the standard, laboratories in other parts of the world can rely on results from another ISO/IEC certified lab. They can expect to reproduce their results given the same raw materials and experiment criteria. 

The Benefits of ISO/IEC 17025 

The standard establishes a baseline for the processes within a lapLab. Everything from the administration to the use of equipment is outlined in the document. Complying with the regulations allows a lab to see significant benefits in its process efficiency. Among the most substantial benefits that ISO/IEC 17025 compliance offers to businesses include: 

  • Proper documentation: As a prerequisite for most ISO standards, documentation needs to be accurate and organized. ISO/IEC 17025 is no exception, and labs have organized and efficient documentation for all of their in-house practices, ensuring that all personnel is aware of how each aspect functions. 
  • Efficient management system: The management system that the standard implements ensure that the company or department utilizes its available resources most effectively. There are no wasted resources that could be better used. 
  • Well-Maintained Testing/Calibration Environment: Testing/Calibration environments need to be constantly maintained to avoid introducing contaminants that may impact the integrity of results. The standard has guidelines to help labs ensure that their testing/calibration grounds are appropriately maintained between use. 
  • Confidence in results: The ISO/IEC 17025 standards allow for labs to have more confidence in their results and ensures that other labs can reproduce those results within a reasonable tolerance. 

    The Core Importance of Having Reliable Testing/Calibration  

    ISO/IEC 17025 addresses a significant dependence on our modern lives. Having confidence in laboratory testing/calibration is vital to the continued running of our daily lives. For labs, being able to state confidently that their results are correct is a massive morale boost. Even third-party labs can benefit from implementing the ISO/IEC 17025 standard since it lets other labs accurately verify their findings. Additionally, implementing the standard ensures that all of the administrative paperwork associated with testing is filed with the relevant authorities quickly. 

    Opening Up Trade and Commerce Through Certification 

    ISO/IEC 17025 is a vital part of any laboratory’s registration. Not only does the standard ensure that the lab follows international best practices, but it also outlines the standards that other labs follow worldwide. The accreditation that ISO/IEC 17025 brings to a business helps ensure that the lab’s results are beyond question. In many jurisdictions, this accreditation may mean the difference between securing contracts and losing them to better-qualified competition. 

    At its heart, the ISO/IEC 17025 is a quality management system explicitly implemented for laboratories. It reflects many of the exact requirements as the ISO 9001 standard but makes it apply specifically to laboratories. It’s no surprise that part of the accreditation process for ISO/IEC 17025 has a working QMS. If you’re interested in exploring ISO/IEC 17025, you’re welcome to contact Sync Resource at your earliest convenience to learn more. Our advisors can help your lab achieve the requirements to get accredited. Contact us now to find out how! 

    What is ISO 17025?

    ISO/IEC17025:2017 specifies the general requirements for the competence to carry out the tests and/or calibrations and sampling for a Test/Calibration Laboratory. It covers testing and calibration performed using standard methods, non-standard methods, Laboratory defined methods.

    What is the difference between ISO 17025 and ISO 9001?

  • ISO 17025 governs the quality of results provided by test/calibration, ISO 9001:2015 does not govern the quality of the product but the process.
  • ISO 17025 emphasis on the technical requirement of the Lab, ISO 9001 does include the technical requirement of the organization.
  • ISO 17025 is accreditation, ISO 9001 is certification.
  • ISO 9001 is the ability to demonstrate the ability of an organization to provide products or services to meet customer requirements.
  • ISO 17025 is a demonstration of competency in performing the test/calibration per the scope.
  • ISO 17025 is for developing the quality of the Laboratory, administration, and technical system that governs the operation of testing or calibration lab.
  • ISO 17025 does not directly provide continuous improvement, ISO 9001 provides the foundation for continuous improvement.

    • What is importance of ISO 17025 certification?

    The benefit of ISO 17025 Accreditation is not limited to:

  • Establish confidence in management and customers on your test /calibration results as well as test /calibration reports and increase customer trust as well.
  • It will give a better image of the company as a Quality producer in the Global Market.
  • Provide hot tips on the analysis of data as well as to measurement the uncertainty and integrity of data and records.
  • Provide guidelines and better control for maintenance of Instruments, environment control, protection of test records, etc.
    The principles of good laboratory practice should be applied to all type of test /calibration laboratory whether private or in-house and in any manufacturing unit for testing/calibration:

    To establish quality in testing/calibration and reliability

  • To prevent risk
  • To detect deviations
  • To correct errors
  • To improve efficiency

    • What is the cost for a small business to get ISO 17025 certified?

    While considering ISO certification it is very critical to understand the various costs incurred.

    These costs include:

    1st Year Cost

  • Create and Charter ISO project (Quality Manager)
  • External Registrar Cost+ Logistic Cost
  • Proficiency Testing & Measurement Uncertainty Calculations
  • Consultant Support( if external consultant used)

    2nd Year Cost

  • Surveillance Audit and Logistics cost.
  • Soft Cost associated with Internal Audit,
  • Reporting, and Maintenance of the QMS

    Recertification cost( every 2 years):

  • External Audit and Logistics cost

    • What is impartiality in ISO 17025?

    Impartiality, as defined in section 3 of the standard, is freedom from bias, prejudice, fairness. Confidentiality in regard to conflict of interest and resolution of issues to prevent their impact on the quality of results reported. Many Laboratories are part of a bigger organization and have shared resources or have internal customers(Sales, Product Launch Managers, Marketing, Production).

    These benefits can present challenges like undue pressure to report specific values, perform test/ calibration to meet the organizational targets, and so on.

    This undermines Laboratories’ competence and credibility. Hence at the Laboratory level implementing safeguards and protocols /rules to ensure that personnel is able to perform their work and report information accurately, without repercussions.

    What is ISO 17025?

    ISO/IEC17025:2017 specifies the general requirements for the competence to carry out the tests and/or calibrations and sampling for a Test/Calibration Laboratory. It covers testing and calibration performed using standard methods, non-standard methods, Laboratory defined methods.

    What is the difference between ISO 17025 and ISO 9001?

  • ISO 17025 governs the quality of results provided by test/calibration, ISO 9001:2015 does not govern the quality of the product but the process.
  • ISO 17025 emphasis on the technical requirement of the Lab, ISO 9001 does include the technical requirement of the organization.
  • ISO 17025 is accreditation, ISO 9001 is certification.
  • ISO 9001 is the ability to demonstrate the ability of an organization to provide products or services to meet customer requirements.
  • ISO 17025 is a demonstration of competency in performing the test/calibration per the scope.
  • ISO 17025 is for developing the quality of the Laboratory, administration, and technical system that governs the operation of testing or calibration lab.
  • ISO 17025 does not directly provide continuous improvement, ISO 9001 provides the foundation for continuous improvement.

    • What is importance of ISO 17025 certification?

    The benefit of ISO 17025 Accreditation is not limited to:

  • Establish confidence in management and customers on your test /calibration results as well as test /calibration reports and increase customer trust as well.
  • It will give a better image of the company as a Quality producer in the Global Market.
  • Provide hot tips on the analysis of data as well as to measurement the uncertainty and integrity of data and records.
  • Provide guidelines and better control for maintenance of Instruments, environment control, protection of test records, etc.
    The principles of good laboratory practice should be applied to all type of test /calibration laboratory whether private or in-house and in any manufacturing unit for testing/calibration:

    To establish quality in testing/calibration and reliability

  • To prevent risk
  • To detect deviations
  • To correct errors
  • To improve efficiency

    • What is the cost for a small business to get ISO 17025 certified?

    While considering ISO certification it is very critical to understand the various costs incurred.

    These costs include:

    1st Year Cost

  • Create and Charter ISO project (Quality Manager)
  • External Registrar Cost+ Logistic Cost
  • Proficiency Testing & Measurement Uncertainty Calculations
  • Consultant Support( if external consultant used)

    2nd Year Cost

  • Surveillance Audit and Logistics cost.
  • Soft Cost associated with Internal Audit,
  • Reporting, and Maintenance of the QMS

    Recertification cost( every 2 years):

  • External Audit and Logistics cost

    • What is impartiality in ISO 17025?

    Impartiality, as defined in section 3 of the standard, is freedom from bias, prejudice, fairness. Confidentiality in regard to conflict of interest and resolution of issues to prevent their impact on the quality of results reported. Many Laboratories are part of a bigger organization and have shared resources or have internal customers(Sales, Product Launch Managers, Marketing, Production).

    These benefits can present challenges like undue pressure to report specific values, perform test/ calibration to meet the organizational targets, and so on.

    This undermines Laboratories’ competence and credibility. Hence at the Laboratory level implementing safeguards and protocols /rules to ensure that personnel is able to perform their work and report information accurately, without repercussions.

    Free ISO Accreditation Executive Guide

    This handy executive guide provides an executive overview of ISO Certification process, ISO requirements and you’ll learn all the key steps to be fully ISO Certified.

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