Accreditation and Certification of the Quality Management System

SCEEMP has a comprehensive quality management system (QMS) based on the national standard GOST R ISO 9001-2015 ‘Quality management systems. Requirements’. It encompasses the QMS developed for the Testing Centres based on GOST ISO/IEC 17025-2019 ‘General requirements for the competence of testing and calibration laboratories’.

The QMS has certification by the InterCertTest Voluntary Certification System for compliance with GOST R ISO 9001-2015 (ISO 9001:2015). Compliance certificate No. РОСС RU.C.04 ША.СК.1586.

The QMS is aimed at ensuring a high level and continuous improvement of the SCEEMP activities. It helps to maintain performance efficiency in line with the stakeholders’ expectations and the applicable regulatory requirements. 

The Testing Centre for Medicinal Products Quality Control (TCMP) and the Testing Centre for Biological Products Quality Control (TCBP) are functional units of SCEEMP. They have accreditation in the national accreditation system under Federal Law No. 412-FZ ‘On accreditation in the national accreditation system’ of 28 December 2013.

• The TCMP is included in the Register of Accredited Bodies under the unique accreditation code РОСС RU.0001.21ФМ29
• The TCBP is included in the Register of Accredited Bodies under the unique accreditation code RA.RU.21ФЛ32

The TCMP laboratories are included in the WHO List of Prequalified Quality Control Laboratories available at the WHO official website

https://www.spc.lk/pub/who-list-of-prequalified-quality-control-laboratories.pdf

https://extranet.who.int/prequal/medicines/prequalified/quality-control-labs

Since 2011, the TCMP was an associate member of the General European OMCL Network (GEON). It has successfully taken part in several mutual joint audits in accordance with the EDQM instruction IS07/02 (V.10) on the OMCL Network Mutual Joint Audit Scheme.

The Metrological Service is a functional unit of SCEEMP and has accreditation in the national accreditation system in accordance with ‘CM N 03.1-9.0005 National accreditation scheme for legal entities and individual entrepreneurs performing instrument calibration. Version 01 March 2022’.

The Metrological Service is included in the Register of Accredited Bodies under the unique accreditation code RA.RU.314289.