The FSBI ‘SCEEMP’ quality management system is a comprehensive system based on GOST R ISO 9001-2015 Quality management systems. Requirements. It encompasses a quality management system developed for the Testing Centres based on GOST ISO/IEC 17025-2019 General requirements for the competence of testing and calibration laboratories.
The quality management system has certification by the InterCertTest Certification System for compliance with GOST R ISO 9001-2015 (ISO 9001:2015). Compliance certificate No. РОСС RU.C.04 ША.СК.1586.
The quality management system is aimed at ensuring a high level and continuous improvement of FSBI ‘SCEMP’ activities. It helps to maintain performance efficiency in line with the stakeholders’ expectations and the applicable regulatory requirements.
Сертификат соответствия ГОСТ Р ИСО 9001-2015 ИСО Консалтинг RU
Сертификат соответствия ГОСТ Р ИСО 9001-2015 ИСО Консалтинг EN
The Testing Centre for Medicinal Product Quality Evaluation (TC MPQE) and the Testing Centre for Biological Product Quality Evaluation (TC BPQE) are functional units of the FSBI ‘SCEEMP’. They have accreditation in the national accreditation system under the Federal Law No. 412-FZ On accreditation in the national accreditation system dated 28 December 2013.
- The TC MPQE is included in the Register of Accredited Bodies, the accreditation code РОСС RU.0001.21ФМ29
- The TC BPQE is included in the Register of Accredited Bodies, the accreditation code RA.RU.21ФЛ32
The TC MPQE laboratories are included in the WHO List of Prequalified Quality Control Laboratories available at the WHO official website https://extranet.who.int/pqweb/sites/default/files/documents/PQ_QCLabsList_28.pdf.
The TC MPQE is an associate member of the General European OMCL Network (GEON). It has 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 and has a valid attestation confirming QMS implementation in accordance with the GEON requirements.
Аттестат EDQM