CRM Advantages – Fulfilling ISO 17025 Requirements

What are Certified Reference Materials for Antimicrobial Testing?

Situ Biosciences’ Certified Reference Materials (CRMs) are quality standards designed to be utilized as test controls in Standard Antimicrobial Methods. Situ Biosciences Certified Treated Test Controls are designed to achieve significant antimicrobial performance in a Method, and Certified Untreated Test Controls are designed to have an extremely poor antimicrobial performance. The desired outcome of a given Method determines how each control is expected to perform.

These values have been determined through the relevant Standard Method performance in Situ Biosciences’ facilities, which are accredited to ISO/IEC 17025, ISO 17034, and Good Laboratory Practices. For answers to our most frequently asked questions, click here.

Why Should I Use a Certified Reference Material?

Gain and Maintain ISO 17025 Accreditation

See below to learn how Situ Biosciences’ Certified Reference Materials can be used to satisfy a wide range of ISO 17025 requirements.

Personnel Training (ISO 17025 § 6.2.5)

Training personnel in Standard Antimicrobial Methods can be challenging due to the inherent variability associated with all microbiological testing, especially when it comes to analyzing the results obtained by trainees.

Certified Test Controls have accounted for this variability to provide a known result; allowing reviewers to more easily evaluate if the trainee obtained the proper result for the sample under test.

Standard Untreated Controls are commonly utilized in employee training and proficiency testing, but these are inconsistent and expected to perform poorly in the method. Due to this, their results may not accurately reflect if the method was not properly performed. Adding a Certified Treated Test Control bolsters the confidence in the performance of the method and the results achieved, as it is significantly more likely that improper performance of the method will be reflected in at least one of the controls.

Metrological Traceability (ISO 17025 § 6.5.3)

Certified Test Controls directly fulfill this section, and may eventually be required. 

For a variety of Standard Antimicrobial Test Methods, it is not technically possible to ensure that measurement results are traceable to the SI units. When metrological traceability to the SI units is not technically possible, ISO 17025 states the laboratory shall demonstrate metrological traceability to an appropriate reference. The certified values of our Certified Reference Materials fulfills this requirement.

Selection, Verification, and Validation of Methods (ISO 17025 § 7.2)

Testing laboratories are required to show that they can properly perform the Standard Method prior to accreditation, and additionally that any modifications to a Standard Method are validated prior to performance.

Instead of having to determine a statistical approach to proving their competence to accrediting agencies, these vital requirements can be fulfilled by simply including Certified Test Controls  in their testing. By consistently achieving the known results at both extremes of a method, laboratories inherently verify their performance of a method, and evaluate if any modifications may have an impact to the ability to accomplish the purpose of the method.

If you need a Certified Reference Material for verification of a method we do not currently have available, contact us to learn how we can create a Certified Test Control to fulfill your need.

Measurement Uncertainty (ISO 17025 § 7.6)

Due to the inherent variability present in microbiological testing, complex statistical calculations are typically necessary to fulfill this requirement.

Certified Test Controls simplify this process by providing an expected, consistent result. This consistency allows laboratories to properly evaluate the variance between replicates and samples over the long term, minimizing the amount of statistics that are needed to support the evaluation of the measurement uncertainty.

Ensuring Validity of Results (ISO 17025 § 7.7)

Fulfillment of this requirement has never been more straight-forward!

By utilizing Certified Test Controls in your antimicrobial testing, and achieving the Certified Values, your performance of the method can be inherently validated. Situ Biosciences can additionally provide blind samples of our Test Controls to further bolster your method performance validation.

If you would like to coordinate an interlaboratory comparison for proficiency testing, contact us to learn how we can help.

Actions to address risks and opportunities (ISO 17025 § 8.5)

Utilization of ISO 17034 Certified Test Controls shows that your laboratory actively seeks out opportunities to assist in achieving the purpose and objectives of the laboratory.

When included in your antimicrobial testing, they will provide insight that will allow laboratories to prevent, or reduce, undesired impacts and potential failures in the laboratory activities.

Improvement (ISO 17025 § 8.6)

Utilizing Certified Test Controls in your antimicrobial testing communicates that your laboratory actively identifies opportunities for improvement and implements them into your procedures.

In addition to this, utilizing our Certified Test Controls in your internal processes such as proficiency testing will provide insight into other potential opportunities for improvement; allowing you to continuously improve and satisfy this requirement long term.

What are the Additional Benefits?

You Can Create Long-Term Control Charts

CRMs will provide insight into the performance of the product, allowing you to create long term control charts to monitor the performance of your products. This insight will allow a customer to make strategic decisions when implementing any design changes to that product or any future products that are developed.

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Standard Controls Can Invalidate Your Testing

Many Standard Antimicrobial Methods have validity criteria requiring the Untreated Control to demonstrate microorganism growth. When the Control doesn’t meet this criteria, your test results may be invalidated – leading to frustrating delays and retests. Some antimicrobial methods will additionally have you evaluate a product’s performance by comparing directly to the control. When the Control displays antimicrobial performance, or simply doesn’t promote growth, this harms the result of your product.

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