On-site peer review of quality management system with respect to requirements of ISO Guide 34

Project Description

The rules of the CIPM MRA require that the NMIs implement and operate a Quality Management System (QMS) complying with ISO/IEC 17025 to support their calibration activities and ISO Guide 34 for the production of certified reference materials. Ulusal Metroloji Esntistütü (UME) started activities related to the production of certified reference materials in 2011. Institutional QMS was extended to meet requirements of ISO Guide 34. The project intends to evaluate the QMS of UME using a peer review performed by experts from EURAMET NMIs. The scope of the peer review will be limited to the requirements of ISO Guide 34 for production of two reference materials, namely pure chloramfenicol and aflotoxins in dry fig. Peer review will fulfill the requirements of the CIPM and of EURAMET.

A peer review is scheduled to October 2012. The results of peer review will be reported to EURAMET TC-Q during annual meeting in 2013.


Final Report 2017-12-18

TÜBİTAK UME started activities related to the production of certified reference materials in 2011 and expressed its interest in a peer review of its quality management system covering production of certified reference materials in accordance with the requirements of the ISO Guide 34 to PTB and LGC during annual TC-MC meeting in February 2012.
Two on-site visits were organised within the framework of the peer project. They were held on 12 October 2012 and on 12 and 13 June 2013. Two technical experts, one from PTB and another from LGC, visited the TÜBİTAK UME and checked the implementation of requirements of the ISO Guide 34 covering production of certified reference materials.
The first visit was focused on the assessment of production of two reference materials, namley; pure chloramphenicol and aflatoxin in dried fig. The peer review resulted in nine findings. Seven out of nine findings had a nature of recommendations for future improvement, while other two had been taken into account with corrective actions.
The second visit was focused on the production process of the spring water certified reference material. Ten findings have been identified and registered during the visit in 2013. Four out of ten findings had a nature of recommendations and other six had been cleared by appropriate corrective actions.
The comprehensive reports for both visits have been prepared for both visits and they are available from project coordinator on request.
As TÜBİTAK UME received accreditation certificate from the Turkish Accreditation Agency (TURKAK) covering production of the certified reference materials (Certificate No: AB-0001-RM) at the end of 2017, it was decided not to continue with peer review and to close the project.

Subjects
Quality (Q)
Coordinating Institute
UME (Türkiye)