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June 2023 (published: 31.05.2023)
Number 2(53)
Home > Issue > Risk-based approach to the organization of internal audit of a testing laboratory
Boyadzhi K.S. , Mishura L.G.
The relevance of the proposed article lies in the need to apply a risk-based approach to enterprise management to ensure the proper quality of products and services provided. The proposal for the introduction of a risk-based approach is considered on the example of the activities of testing laboratories. The proposal to introduce a risk-based approach was considered when organizing an internal quality audit of the testing laboratory. Only the test results of an accredited laboratory can be considered reliable and serve as a reason for issuing a certificate of conformity for a particular product. In the modern world, there is an increasing trend in the purchase of goods marked with the corresponding quality mark, as more and more consumers are striving to get their hands on just such products that would meet all the necessary quality features. For thorough preparation for accreditation, the laboratory conducts an internal check - an internal audit. The activities of testing laboratories are regulated by the GOST ISO IEC 17025 standard. In the latest edition of this standard, the main emphasis is on the use of a risk-based approach. The purpose of the work is to develop an algorithm for conducting an internal audit of a testing laboratory using a risk-based approach. In the work, such research methods as the analytical method, the abstraction method, the formalization method and the generalization method were used. An analysis of the available risk management methods was carried out and, according to certain parameters, such as time costs, the need for initial data, the necessary skills and experience of a specialist and the complexity of the analysis, those methods were selected that are most suitable for assessing the risks of the testing laboratory. The risk management scheme was considered in relation to the process of internal audit of the quality of the testing laboratory, and this scheme was introduced into the algorithm for conducting internal audit. A criterion for the frequency of internal audit of the process has been developed, which allows you to determine the number of audits of a particular process during the year. The criterion, depending on the risk assessment method used in the laboratory, is ranked as follows: 1 check per year is required; 2 checks per year required; an unscheduled audit may be required. Thus, the proposed algorithm for organizing an internal quality audit can allow the testing laboratory to conduct inspections more efficiently, first of all, paying attention to the most important and problematic processes, which in the future will help to identify the majority of inconsistencies and successfully pass the accreditation procedure.
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Keywords: risk-based approach, internal audit, GOST ISOIEC 17025, ISO 19011, internal audit frequency criterion, internal audit algorithm.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License
UDC 658.56
Risk-based approach to the organization of internal audit of a testing laboratory
The relevance of the proposed article lies in the need to apply a risk-based approach to enterprise management to ensure the proper quality of products and services provided. The proposal for the introduction of a risk-based approach is considered on the example of the activities of testing laboratories. The proposal to introduce a risk-based approach was considered when organizing an internal quality audit of the testing laboratory. Only the test results of an accredited laboratory can be considered reliable and serve as a reason for issuing a certificate of conformity for a particular product. In the modern world, there is an increasing trend in the purchase of goods marked with the corresponding quality mark, as more and more consumers are striving to get their hands on just such products that would meet all the necessary quality features. For thorough preparation for accreditation, the laboratory conducts an internal check - an internal audit. The activities of testing laboratories are regulated by the GOST ISO IEC 17025 standard. In the latest edition of this standard, the main emphasis is on the use of a risk-based approach. The purpose of the work is to develop an algorithm for conducting an internal audit of a testing laboratory using a risk-based approach. In the work, such research methods as the analytical method, the abstraction method, the formalization method and the generalization method were used. An analysis of the available risk management methods was carried out and, according to certain parameters, such as time costs, the need for initial data, the necessary skills and experience of a specialist and the complexity of the analysis, those methods were selected that are most suitable for assessing the risks of the testing laboratory. The risk management scheme was considered in relation to the process of internal audit of the quality of the testing laboratory, and this scheme was introduced into the algorithm for conducting internal audit. A criterion for the frequency of internal audit of the process has been developed, which allows you to determine the number of audits of a particular process during the year. The criterion, depending on the risk assessment method used in the laboratory, is ranked as follows: 1 check per year is required; 2 checks per year required; an unscheduled audit may be required. Thus, the proposed algorithm for organizing an internal quality audit can allow the testing laboratory to conduct inspections more efficiently, first of all, paying attention to the most important and problematic processes, which in the future will help to identify the majority of inconsistencies and successfully pass the accreditation procedure.
Read the full article
Keywords: risk-based approach, internal audit, GOST ISOIEC 17025, ISO 19011, internal audit frequency criterion, internal audit algorithm.
DOI 10.17586/2310-1172-2023-16-2-44-54