HYDRANAL® HYDRANAL® Service Lab - Accreditation

Increasing Reliability and Value of Analytical Results
Sigma-Aldrich achieves accreditation according to ISO/IEC 17025 for Water Standards and Karl Fischer Reagents

Sigma-Aldrich’s HYDRANAL service laboratory in Seelze, Germany, proved its expertise for testing and calibration and achieved accreditation as a testing laboratory according to ISO/IEC 17025:2005 ‘General requirements for the competence of testing and calibration laboratories’. It was audited by the German Accreditation Council (Deutscher Akkreditierungsrat DAR) and received accreditation for titration and gravimetry for water standards and reagents for Karl Fischer titration.

From the beginning of our HYDRANAL product line over 30 years ago, the HYDRANAL technical service in Seelze has applied a high standard and continual improvement of testing methods for production and quality control of HYDRANAL water standards and HYDRANAL Karl Fischer reagents. These high-quality testing methods have now been proven to comply with the high standards of the auditors and have led to the accreditation of HYDRANAL Technical Service according to ISO/IEC 17025. This accreditation includes all HYDRANAL products, and the accreditation details, along with the logo of the accreditation body, will now appear on the Certificate of Analysis (see Figure 1) and on the label for each produced lot.

Accreditation requirements and procedure

Accreditation means that an authoritative body formally recognizes that an organization or individual is competent to execute a specific service as described in the scope of accreditation. ISO/IEC 17025 is associated with a well defined analytical technique and a stated measurement range comprising analyte, matrix and concentration range. This is called the scope of the accreditation. In this case, HYDRANAL Technical Service is accredited to perform titration and gravimetry for water standards and reagents for Karl Fischer titration according to the following methods/norms: ISO 760:1978-12, ASTM E203-08 and HYDRANAL Technical Service’s in-house methods 01-04.

To fulfill the requirements of ISO/IEC 17025, a laboratory must demonstrate its general competence and compliance in performing specific tests or calibrations, as well as establishing and documenting its quality management system. Beyond the basic management requirements of ISO 9001, ISO/IEC 17025 requires the following topics:

• Instrument qualification
• Validation of analytical methods
• Traceability statements
• Evaluation of measurement uncertainty
• Ongoing education of personnel
• Periodic participation in proficiency tests to demonstrate technical capability

Following the accreditation, evidence of continued improvement is required, including regular internal audits and the demonstration of efforts towards scientific and technological progress.

Figure 1 … Example of HYDRANAL Certificate of Analysis with accreditation details:

Analytical results produced in laboratories fulfilling ISO/ IEC 17025 can be labelled with a special quality logo that confirms the reliability of the results. Every country has at least one official body that is responsible for accreditation, and each body signifies its accreditation with its own unique logo. Since HYDRANAL Technical Service was accredited by DAR, the DAR symbol and the individual registration number of the laboratory must appear on the certificate of Karl Fischer reagents and water standards. Beginning in 2010, the authoritative body for accreditations in Germany is the Deutsche Akkreditierungsstelle (DAkkS), which will also administrate accreditations issued by former authorities.


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