Implementation of Risk Management

in Organizations for Сonformity Assessment

N.Yu. Mysik, Chief Specialist (in Quality), Federal Budget Institution State Regional Center of Standardization, Metrology and Testing in Sverdlovsk Region (FBU URALTEST), Ekaterinburg, Russia, nmysik@uraltest.ru

key words

risk management, measuring instruments, tests, laboratory, processes, methods, elements of analysis

References

We proposed an algorithm for applying analysis and processing of risks for a particular process in our organization. This algorithm is used in the development, implementation and application of the quality management system for compliance with the requirements of GOST R ISO 9001–2015 and the formation of a risk management structure, including for testing and calibration processes. Its purpose is the initial systematization and understanding of the risk structure of a specific activity, which would allow further to move to more in-depth tools for risk assessment and monitoring, the formation of measures to manage them.

The process risks were analyzed on the basis of the consolidated information on the specific process, identifying its essence, interrelations with other processes, negative and positive factors of the process.

1. ISO 9000:2015 Quality management systems — Requirements.
2. GOST R ISO 9001–2015 Quality management systems. Fundamentals and vocabulary.
3. ISO 17025:2017 General requirements for the competence of testing and calibration laboratories.
4. ISO 17025:2005 Cor 1:2006 General requirements for the competence of testing and calibration laboratories.
5. GOST R ISO/IEC 17025–2009 General requirements for the competence of testing and calibration laboratories.
6. ISO 31000:2018 Risk management — Guidelines.
7. GOST R ISO/IEC 31010–2011 Risk management. Risk assessment techniques.
8. RF Ministry of Economic Development order on 30.05.2014 N 326 On approval of the accreditation criteria, the list of documents confirming the compliance of the accredited person with the accredited person with the accreditation criteria, and the list of documents in the field of standardization, compliance with the requirements of which applicants, accredited persons ensures their compliance
with the accreditation criteria with changes.
9. ILAC-P10:01/2013 ILAC Policy on the Traceability of Measurement Results.
10. ISO 9000:2015 Quality management systems — Fundamentals and vocabulary.
11. GOST R ISO 9000–2015 Quality management systems. Fundamentals and vocabulary.