The reliability of an analytical instrument depends upon its reference. This is why certified reference materials (CRMs) are so important. Without them, setting a standard of accuracy to validate the outcome of an experiment would be difficult.
By utilizing a CRM, you are comparing the measurements of your instrument to those traceable to an SI base unit. This offers the opportunity to regulate technology to ensure its results are consistent. CRMs are used by laboratories, however they also offer a means of control over the quality of different products, including those within food- and health-related industries.
Unfortunately, not all analytical methods are best suited to work with general CRMs. In situations where this occurs, bespoke CRM designs can keep measurements in line with expected regulations. These custom standards must be reinforced by the guidance set by the International Organisation for Standardization (ISO), being substantiated through their traceability and the potential uncertainties of each measurement.
With that said, if you are interested in custom standards, and want to learn more about bespoke certified reference material designs, we invite you to read on. By the time you finish this article, you will know what to consider when deciding upon your own custom standards.
Understanding ISO Standards and Their Impact on Certified Reference Material Designs
ISO 9001: Quality Management Systems
ISO 9001 is essential for ensuring quality in the production, design, and continuous improvement of certified reference materials. This standard supports the rigorous development and maintenance of high-quality certified reference material designs through:
- Documented procedures
- Customer feedback
- Product design.
ISO 17025: Competence of Testing and Calibration Laboratories
ISO 17025 accreditation is crucial for laboratories involved in the testing and calibration of CRMs. It ensures that the processes related to the design, production, and certification of CRMs are performed competently. That way they can generate reliable results, reinforcing the trust in CRMs used for calibration and testing purposes.
ISO 17034: Competence of Reference Material Producers
Specifically tailored to the needs of CRM producers, ISO 17034 establishes rigorous requirements for the production of CRMs. It covers the validation of certification methods and the accuracy of standards. This ensures that CRMs are produced to the highest quality standards for use in testing, calibration, and research.
Key Considerations for Certified Reference Material Designs
Production by ISO 17034 Accredited Producers
Ensuring CRMs are produced by ISO 17034 accredited manufacturers is fundamental for quality assurance. This accreditation guarantees that the CRMs meet the required standards for accuracy and reliability, making them suitable for precise scientific and industrial applications.
Handling and Storage
Proper handling and storage conditions are crucial for maintaining the integrity of CRMs. Factors such as sensitivity to light, air, temperature control, and preparation frequency must be carefully considered. That way the CRMs can remain stable and reliable over time.
Documentation and Traceability
Adherence to ISO Guide 31 standards for documenting CRMs is paramount. Comprehensive documentation ensures traceability, detailing the origin, composition, and calibration of CRMs. This is critical for compliance, quality assurance, and the reproducibility of results in scientific research and industrial applications.
Ensuring Reliable Measurements with Method Validation
Robustness Testing
Testing the robustness of certified reference materials assesses their performance under varied operational parameters, ensuring reliability across different conditions and applications. This is essential for maintaining the integrity of measurements and analyses in which CRMs are utilized.
Collaborative Testing
Participation in collaborative testing, especially interlaboratory comparisons, is vital for verifying the precision and reproducibility of CRMs. Such testing reinforces the credibility and acceptance of CRMs across various laboratories and institutions.
Accuracy and Sensitivity
The accuracy and sensitivity of CRMs are established through rigorous comparisons and validations. Ensuring that CRMs align with certified standards or validated methods is crucial for their effective use in:
- Scientific research
- Testing
- Calibration.
Create Your Own Custom Standards With The Help Of Inorganic Ventures
Custom standards can help to ensure that the results of an experiment are regulated and their generated measurements are confirmed as accurate. The very nature of experimentation means that while consistency is required to verify a robust result, adaptability is also needed to ensure new research can be undertaken without being inhibited. This is where bespoke CRM designs and custom standards can find their place and purpose.
Should you require help with designing your own custom standards, we, Inorganic Ventures, can offer our support. Custom standards are our speciality. Therefore, we are more than happy to utilize our skills to produce a bespoke CRM design that can help you achieve a measurement that is reliable.
Essentially, we want to simplify the process behind custom standards and bespoke certified reference material designs for you. So, utilize our experience to ensure that you get a standard that can be relied upon. We can create custom standards, but also have a library that holds above 57,000 combinations. Contact us today to find the perfect custom standards for you and your measurements.