Quality Assurance



Conformity with International standards


Quality understanding is a matter handled and managed at the highest level within Labsert. This is also a matter used as a management system not only in manufacturing process but also in fields such as management of customer services, shipments, human resources etc. Improvement of quality system is carried out as a regular work in Labsert. We provide necessary resources and carry out our operations by being aware that total quality understanding is the fundamental source of sustainability in all activities of the company.

 

Labsert has ISO 9001 certification from DAKKS (National accreditation body for the Federal Republic of Germany). All analysis and tests during certification works are carried out at ISO 17025 accredited sub-contracted business partnership laboratories and/or Labsert laboratories. Manufacture of the standards is implemented according to ISO 17034 conditions. 


Analysis Quality of Certification Process

Quality and results of reference standards certification process are among the most important issues for users. As Labsert, we apply a process beyond recognized international certification conditions at this point in order to ensure international quality and to keep reliability of results at the highest level. In addition to generally applied international certification analysis processes:

 

  • In the certification process, results are compared by using instrumental and/or gravimetrical analysis.
  • Analyses are compared with different quality control standards.
  • All analyses are implemented pursuant to ISO 17025 conditions.
  • Measurement uncertainty and validation/ verification works are carried out for each analysis parameter.
  • For applicable analyses, instrumental analysis and wet analysis are compared with each other and reliability of results is tested additionally.

 

In addition to these conditions, additional tests and analyses carried out as per ISO 17034 conditions:

 

  • Homogeneity tests of products are implemented in and between bottles/ packages for each lot.
  • Short term stability tests are implemented.
  • Long term stability tests are implemented.


Raw Materials and Packaging Quality


All raw materials used for manufacture of reference materials are selected at minimum purity level of 99%- 99.99% depending on production field and under possible supply conditions.  Attention is paid to ensure that all solvents used for manufacture are ultra-pure (Chromatography grade). Temperature and humidity controls are carried out and recorded daily in manufacturing and storage areas. Low particles HDPE (High Density Polyethylene) or PPCO (Poly-Propylene Copolymer) bottles are used for product packaging. Metal and ionic total residual concentrations within structures of these bottles are 2000-20.000 times lesser than glass bottles. Bottles are subjected to bacterial and residual control by suitable wave length lamps before getting it into use.  Following completion of manufacture, bottles are made ready for shipment by being placed in aluminum locked packages to minimize environmental effects and for extra protection. 


NIST Traceability


Manufacture of reference standards meets conditions to ensure NIST (when available) and SI unit based traceability. During instrumental quantitative analysis within our certification process, calibration curves are generated by NIST traceable certified reference materials. Furthermore, calibration is also carried out by weights having NIST traceability for all mass measurements used for certification. Considering manufactures or methods where NIST traceability is not possible, similar metrological traceabilities or traceability with secondary source reference materials are provided.