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 our sub-contracted business partnership laboratory (ISO 17025 accredited by TURKAK: AB-0375-T) and/or Labsert laboratories. As a part of manufacturing process of reference standards, detailed result of analysis is presented on a report which is prepared according to ISO 17034 assessment (Certified by Turcert: 20180718172822). Products certification of chemicals and sorbent materials are prepared according to ISO 9001 procedures.


Our certified reference materials were published in reference material producer database by TURKAK (Turkish Accreditation Agency). You can find information of our products on TURKAK web site by entering REMBIS database.


Labsert's manufacturing capacity is registered by The Union of Chambers and Commodity Exchanges of Turkey (TOBB) with a capacity report. Our manufacturing capacity is officially controlled by TOBB during our capacity report's currency (Report No: 11/2018)


Quality of Services and Manufacturing Process

Quality managements in all manufacturing 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. Some important levels in quality assurance are:

 

  • In the certification process of reference standards, Quechers kits and SPE columns, all results are compared by using instrumental and/or gravimetrical analysis.
  • Chemical analyses are compared with different quality control standards. All analyses are implemented pursuant to ISO 17025 conditions.
  • As a part of reference standard manufacturing, 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.
  • Quechers kits are manufactured in compliance with AOAC and EN methods
  • Manufacturing of mechatronic systems and devices is carried out according to CE regulations and ISO 9001 procedures.
  • Inter-laboratory comparison tests are organized by taking into consideration the ISO 17043 requirements.
  • Statistical calculations, homogeneity and stability tests are carried out according to ISO 13528 standard in comparison tests.

 

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

 

  • 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 manufacturing are selected at the highest purity, legal conformity and standards-compliant depending on production field and under possible supply conditions.


Raw materials used for manufacturing of reference standard materials are selected from reference standard materials and/or high purity organic compounds. Attention is paid to ensure that all solvents used for manufacture are ultra-pure (Chromatography grade). Amber glass bottles, amber glass ampules, low particles HDPE (High Density Polyethylene) or PPCO (Poly-Propylene Copolymer) bottles are subjected to bacterial and residual control by suitable wave length lamps before getting it into use. 


In manufacturing Quechers kits, Pre-Tested Leak Proof Tubes, Extra Dried Salts, High-Purity Phase Chemicals and Disposable Slim Salt Packs are used to ensure high quality for customers. We also use extra dry and pure sorbent chemicals in manufacturing of SPE columns.


For mechatronic systems, chemical and heat resistance materials are selected. All materials which are used in manufacturing of mechatronic systems and devices, are bought according to technical specifications that include requirements for CE conformity, ISO standards conformity, legal safety regulations etc. 


Temperature and humidity controls are carried out and recorded daily in manufacturing and storage areas. Following completion of manufacture, products are made ready for shipment by being placed in suitable packages to minimize environmental effects and for extra protection. 


NIST Traceability for CRM


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 traceability or traceability with secondary source reference materials are provided. 



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