of March 30, 2017 No. 328
About approval of Rules of validation of methods and techniques of judicial and expert researches
According to the subitem 9) of article 12 of the Law of the Republic of Kazakhstan of February 10, 2017 "About judicial and expert activities" I ORDER:
1. Approve the enclosed Rules of validation of methods and techniques of judicial and expert researches.
2. To provide to department of the organization of expert activities of the Ministry of Justice of the Republic of Kazakhstan in the procedure established by the legislation:
1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;
2) within ten calendar days from the date of state registration of this order the direction of copies of this order in paper and electronic type, persons assured by the digital signature, the representative to sign this order, for inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;
3) placement of this order on Internet resource of the Ministry of Justice of the Republic of Kazakhstan.
3. To impose control of execution of this order on the supervising deputy minister of justice of the Republic of Kazakhstan.
4. This order becomes effective after ten calendar days after day of its first official publication.
Minister
M. Beketayev
Approved by the Order of the Minister of Justice of the Republic of Kazakhstan of March 30, 2017 No. 328
1. These rules of validation of methods and techniques of judicial and expert researches (further – Rules) are developed according to the subitem 9) of article 12 of the Law of the Republic of Kazakhstan "About judicial and expert activities" and determine procedure for validation of methods and techniques of judicial and expert researches.
2. These rules extend to non-standard, again developed or advanced methods and techniques of judicial and expert research and are aimed at providing proper quality of the judicial examinations of methods and techniques of judicial and expert research applied in case of production.
3. These Rules establish the main requirements to the organization, procedures of validation, statistical processing of the received results, reporting forms upon termination of the procedure of validation, criteria for evaluation of results of validation of the quantitative, qualitative, identification and diagnostic methods constituting technique of judicial and expert research.
4. Validation – assessment of suitability of use of methods and techniques of judicial and expert research which is carried out according to the procedure, established by the legislation of the Republic of Kazakhstan which purpose is establishment of correctness, accuracy, reproducibility, stability of the indicators (when conducting interlaboratory researches) used in case of production of judicial examinations of non-standard, again developed or advanced methods and techniques of judicial and expert research on condition of safety of initial properties and stability of the analyzed indicator.
5. Validation there undergo methods and techniques of judicial and expert researches, disconnect in the State register of techniques of judicial and expert researches of the Republic of Kazakhstan, and also methods in again developed techniques of judicial and expert research.
6. The procedure of carrying out validation is determined by type and specifics of method and technique of judicial and expert research on results of analytical testing which each stage serves as the proof that application of the method and technique which is exposed to validation corresponds to receipt of the results planned in case of application of this method.
7. When holding procedure of validation, the quantity and quality characteristics connected with obtaining which are provided by method or technique of judicial and expert research application of control and standard samples is necessary.
Control and standard samples can be received by the expert in the course of application of other methods or techniques of judicial and expert research.
As control and standard samples also the objects conforming to the international, national and other standards are used.
8. The procedure of validation is carried out in the form of interlaboratory checking of results of application of method or technique of judicial and expert research with subsequent assessment of results taking into account the factors exerting impact on validation (technical characteristics of the equipment, the materials used in the course of validation, condition of carrying out validation).
9. When carrying out validation at least three testing at each stage taking into account change of conditions of validation are carried out.
10. The staff of bodies of judicial examination, persons who are engaged in judicial and expert activities based on the license, court experts of foreign state according to article 62 of the Law of the Republic of Kazakhstan "About judicial and expert activities" participate in procedure of validation (further – participants of the procedure of validation).
11. In case of validation of new methods determine characteristics (property) of method and indicators of its accuracy.
Carry to the characteristic of method:
1) specificity – capability of method to establish exclusively analyzed substance, condition, actual data;
2) linearity – method capability within the set range of the carried-out testing to yield the results pro rata to the quantitative indices in standard sample applied in case of validation of quantitative methods;
3) the range of the determined sizes – the interval between upper and the lower measure values, received when carrying out validation of quantitative method, shall not exceed values of 10% of the received quantitative values;
4) limit of detection or limit of quantitative determination – the minimum quantitative index of results of the carried-out testing using validiruyemy method;
5) sensitivity – capability of method to react to any changes of conditions of holding procedure of validation of method.
The choice of characteristics depends on scope of validiruyemy method.
Indicators of accuracy are:
pretsizionnost (repeatability and reproducibility);
correctness.
Indicators of accuracy are determined in production process of judicial examinations.
In case of validation of advanced methods of judicial and expert research determine accuracy indicators.
Correctness is established for the methods intended for:
expansions of scope of methods of judicial and expert research;
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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