Introduction on how ISO 17034 ensures CRM quality

Introduction on how ISO 17034 ensures CRM quality

When it comes to analytical chemistry, precision and accuracy are paramount. Laboratories worldwide rely on Whether in pharmaceuticals, environmental testing, or petroleum analysis, the reliability of measurement results depends heavily on the quality of reference materials and calibration standards used in the laboratory. Certified Reference Materials (CRMs), reference materials and calibration standards to ensure accuracy in their measurements, but not all CRMs are manufactured and certified the same. Accreditation under ISO 17034 plays a critical role in differentiating high-quality CRMs from those that lack rigorous validation.

In this blog, we will explore what ISO 17034 is, why it is essential for CRM quality, and how ARO Scientific ensures compliance with this standard to deliver reliable reference materials to laboratories worldwide.

What is ISO 17034

ISO 17034 is the internationally recognised standard that specifies general requirements for the competence of reference material producers. This accreditation ensures that certified reference materials are produced under strict quality control measures, with traceability and reliability at the core.

A reference material producer that meets ISO 17034 accreditation has demonstrated its ability to produce high-quality, compliant CRMs that meet scientific and regulatory standards. The standard covers:

The selection and characterisation of reference materials
Homogeneity and stability testing
Correct certification and documentation 
Competency of personnel and quality assurance procedures

Why is ISO 17034 important for CRMs?

1. Guarantees traceability and reliability  

ISO 17034 ensures that certified Reference Materials (CRMs), reference materials and calibration standards are produced with full traceability to national or international measurement standards. This means that labs using these CRMs can trust their test results and compare them across different laboratories with confidence.  

2. Enhances regulatory compliance

Many industries require laboratories to use ISO 17034 accredited CRMs to comply with regulations set by bodies like the FDA, EPA, and ISO. Using non-accredited CRMs can lead to compliance issues and unreliable measurement results.

3. Ensures long-term stability of reference materials

CRMs must remain stable over time to provide consistent results. ISO 17034 requires producers to conduct rigorous stability testing to ensure the material maintains its properties under specified conditions.

4. Measurement uncertainty

One of the biggest challenges in analytical testing is considering and accounting for measurement uncertainty. ISO 17034 accredited CRMs have certified values with known uncertainties, allowing laboratories to factor these into their calculations for accurate measurement results.

5. Supports method validation, method verification and instrument calibration

Laboratories must validate or verify their testing methods and calibrate instruments regularly. ISO 17034 accredited CRMs provide a reliable benchmark to ensure that methods and instruments are performing as expected.

How ARO Scientific ensures ISO 17034 compliance

At ARO Scientific, our ISO 17034 accredited Certified Reference Materials (CRMs), reference materials and calibration standards are designed to meet the highest industry standards, ensuring accuracy, reliability, and compliance. Here’s how we uphold ISO 17034 requirements:

Stringent production controls – We follow rigorous procedures in selecting and characterising materials to ensure homogeneity and stability.
Certified traceability – Our CRMs are traceable to recognised national and international standards, giving confidence to laboratories in their testing accuracy.
Continuous quality assurance – We regularly evaluate our materials to maintain ISO 17034 compliance, ensuring consistency in our product offerings.
Comprehensive documentation –Every CRM we produce comes with a detailed certificate that includes certified values, uncertainties, and traceability information.

What choose ISO 17034 accredited CRMs from ARO Scientific

By choosing ARO Scientific’s ISO 17034 accredited CRMs, laboratories can ensure:

Accurate and reproducible measurement results
Compliance with regulatory requirements 
Accurate and valid measurement uncertainty  
Confidence in laboratory qaulity assurance programs 

Conclusion

ISO 17034 accreditation is a crucial factor in determining the quality and reliability of Certified Reference Materials (CRMs), reference materials or calibration standards. Laboratories that prioritise accuracy and compliance should always use CRMs from accredited producers. ARO Scientific remains committed to delivering ISO 17034 compliant reference materials to support analytical laboratories in achieving precise, reliable, and compliant measurement results.

Quality Commitment

ARO Scientific Ltd recognises that our customers should be always provided with products and services they can reply upon, trust and have confidence to use on a daily basis. Our commitment to quality and our accreditations demonstrates that we have rigorous quality systems in place that allow us to provide customers with the highest quality products possible, which are accepted globally. 

Our ISO 17034 schedule of accreditation can be viewed and downloaded on the UKAS website. ISO 17034 schedule of accreditation

Visit ARO Scientific to explore our full range of CRMs to support your laboratory requirements.