Although ISO/IEC 9001, 17025 and17034 (Reference Material Producer) accreditation considers Reference Material Producers technically competent to produce products that are acceptable in the marketplace, the individual product's quality may not be routinely fit for use.
What makes one producer's products routinely better than another's?
First, it's starting the process with better material. If the technical expertise employed in its manufacture is better, the end result will be better. WHRM starts its characterization process with better material.
Second, it's having better characterization of the material (more robust sample analysis techniques and statistical evaluation).
Thirdly, it's employing judicious and continuous internal assessment audits for EACH lot produced to be sure no step is performed poorly or missed altogether (our Production Tracking Document sets a protocol that scrutinizes every production step that has the potential to negatively affect characterization quality).
ISO/IEC has recently updated their accreditation requirements with a risk-based evaluation of processes with a focus on performance to meet customer's expectations (providing the producer's SOPs are followed). Our performance is evaluated continuously to surpass all requirements of ISO/IEC 9001, 17025 and17034, as well as incorporate a much more robust calibration and sample analysis protocol than ASTM E1447
White Horse Technical Services, and its wholly-owned subsidiary White Horse Reference Materials exceeds the requirements of the ISO/IEC for competency and improvement. Our Certified Reference Material (titanium pin standards) are qualified to be used for Calibration Standards Check Standards, Control Samples and Drift Standards.
Having 30+ years' experience in helping laboratory managers get the best performance from their instruments (PM and repair/rebuild), there is a firm grounding in how to perform analyses properly, and to make sure the instrument is working at peak performance.
In addition, 6 years as an active member assisting in the development of ASTM test standards, provides a deep understanding of how important robust procedures can be developed to raise the bar for characterization of reference materials.
Research and development of new material production technologies and SI comparison equipment, with proven results for better products and better characterization capabilities have been developed to advance CRM production.
As a Reference Materials Producer (RMP), WHRM has developed a characterization protocol that utilizes its own carefully established characterization data in conjunction with data supplied by qualified independent laboratories for its Certified Reference Material pin standard products. This establishes a COA that statistically represents both a carefully established view to the SI unit, and also analysis data from various qualified external laboratories for both the estimated true value and its associated uncertainty. This process was utilized during the production of NIST SRM 2453a and NIST SRM 2454a as well as our other products.
Our Internal Quality Control (IQC) utilizes a Production Tracking Document (PTD) that controls and documents the process of production of our titanium pin standards from receipt of candidate RM material through the entire process of acceptance, analysis, certification and the eventual re-testing for stability analysis and re-issuance/revision of expired COAs.
To meet our highest client expectations, we have developed a robust in-house Standard Test Method (WHRM STM) based on ASTM E1447 and ASTM E1409 (for Hydrogen, Nitrogen, Oxygen and Carbon analysis in titanium) along with a robust statistical analysis protocol that provides data that not only compares the samples to the SI unit for true value estimation, but also provides extensive data that enables the statistician to carefully evaluate the equipment's performance during use to for signs of issues such as drift and poor precision that would compromise the integrity of the data.
For the whole story about our robust Standard Test Method and statistics, Click here.