Requirements for the testing laboratory, according to SDA-15-2009 (section 4):
1.1. A testing laboratory (IL) having the status of a legal entity must satisfy the following independence criteria:
– should be independent of parties interested in the test results;
– should not participate in the development, manufacture, construction, installation, repair, reconstruction and operation or be a buyer, owner, tenant of the objects, the tests of which she carries out.
1.2. IL, which is a structural unit of the organization, must meet the following independence criteria:
- within the organizational structure of the organization, the duties and responsibilities of the personnel performing the tests and the personnel performing other functions should be clearly delineated, as well as the reporting of the IL before the organization of which it is a structural unit;
– IL personnel should not experience commercial, financial and other pressure that may affect the test results;
– The IL should not engage in activities that could affect the independence of its judgments and the impartiality of its testing activities.
1.3. IL, which is a structural unit of the organization, but performing tests for third-party organizations under contract agreements, must comply with the requirements of clauses 1.1. and 1.2.
2.1. IL should have a quality system corresponding to the nature of the work performed. The quality system is described in the Quality Manual and approved by the head of the IL. The quality manual is carried out in the form of a single document or in the form of a system of documents that include the main document — the Quality Manual and separate annexes to it.
2.2. The management of the IL should define and document its policies and goals, as well as commitments in the field of quality, and provide an understanding of this policy, its implementation and support at all levels within the organization, including the following:
2.3. The management of the IL should appoint an official directly reporting to him, responsible for ensuring the quality of the IL.
2.4. The documents of the quality management system should be accessible to the personnel of the IL, and the contents of the documents should be communicated to the contractors.
2.5. The quality manual should include or contain as links:
The quality manual should contain references to normative technical documents that are in force in the established order and are used during testing, and should be constantly updated (it should be made all changes occurring in the quality management system). If the organization has a common quality system, the development of a separate Quality Guide for IL is not required provided that it complies with the requirements of GOST ISO / IEC 17025-2009 and this document.
The IL should develop and maintain documentation management procedures that include:
The IL shall establish and maintain procedures for the examination of applications for tests that guarantee:
5.1. When transferring work to a subcontractor, IL must notify the customer in writing. IL must enter into contracts for subcontracting work on tests only with organizations that meet the requirements of this document.
5.2. IL must register all subcontractors and suppliers of products. IL is responsible to the customer for the work performed by the subcontractor, unless the customer chooses the subcontractor.
6.1. In IL, procedures should be developed for the acquisition, receipt and storage of test tools that affect the quality of the tests.
6.2. IL must ensure the safety of the received test means. If necessary, before using the test means, they must undergo an incoming inspection for compliance with national standards, technical specifications, requirements of procedures or other documents establishing product requirements.
6.3. In IL, storage of supporting documentation for the supplied test means and its analysis before using the supplied test means should be organized.
6.4. The IL shall conduct an assessment of suppliers of the most important test instruments affecting quality, keep documents on this assessment and a list of suppliers of test instruments.
7.1. IL must collaborate with test customers (ensuring confidentiality with other customers). Cooperation can be carried out in the following:
7.2.IL is recommended to organize feedback with customers (surveys, questionnaires, etc.) and discussion of test results to improve testing and improve the quality management system.
IL must have a policy and develop procedures for the consideration and registration of appeals, claims, complaints. All documents for consideration of controversial issues, including records of corrective actions, must be kept.
The IL should have a policy and develop procedures to ensure that if any aspect or test result does not comply with the procedures established in the IL, the requirements of the methods, or the requirements agreed with the customer, then:
IL must constantly improve the effectiveness of its quality management system, using:
The IL must have a policy and develop procedures for corrective actions in case of discrepancies or deviations from the policies and procedures provided for by the quality management system or technical operations.
Corrective actions begin with an analysis of the causes of discrepancies in all elements of the quality management system and technical operations. These include: customer requirements, personnel, testing equipment, test procedures, test tools and other elements.
Corrective action must be commensurate with the scope and danger of incongruities. All changes in corrective actions document and organize control over their implementation.
If a preventive action is required, an action plan is developed and implemented to reduce the likelihood of a repeat of nonconformities of a technical nature or related to the quality management system.
13.1.IL should develop and implement procedures for identification, collection, indexing, systematization, access, maintenance, storage and withdrawal of records on the quality management system and technical issues. The time limits for keeping records should be established in the IL and their safe and confidential storage should be ensured.
Entries must be stated in clear, understandable language. For records on electronic media, procedures must be developed for their protection, including from unauthorized changes and restoration.
Records on the quality management system include: reports on internal and external audits, results of analysis by the management, records of corrective and preventive actions.
13.2. Technical records should contain a sum of information and data reflecting the results of all stages of testing. Records should contain information sufficient to reproduce tests that are as close as possible to the originally conducted tests, and, if necessary, to assess factors affecting the inaccuracy of the test. The records should contain information about the personnel involved in the selection of samples (samples), who conducted each stage of the test, carried out control of the test results.
In case of errors in the records, they are corrected by striking out the erroneous and applying the correct values, which is certified by the signature of the person who made the changes.
Records must be kept in the IL for the period established by the quality management system.
IL must periodically, in accordance with the schedule, conduct internal audits of the existing quality management system. The frequency of internal audits at least once a year. The audit program should cover all elements of the quality management system, including testing activities. Inspections should be carried out by trained and qualified personnel.
If inconsistencies are identified in the quality management system, corrective measures are planned and carried out and subsequent checks should confirm and document the elimination of identified inconsistencies.
The management of the IL in accordance with the schedule periodically (as a rule, once a year) carries out an analysis of the quality management system and testing activities. The analysis should take into account:
The results of the analysis are documented and should include actions to improve the quality management system, as well as the need for the necessary resources. Based on the results of the analysis, measures are developed and implemented in a timely manner.
IL management should periodically (as a rule, annually) review the quality management system to ensure its suitability and effectiveness.
Requirements for the testing laboratory, according to SDA-15-2009 (section 5).
The IL should develop, document and ensure that the requirements for tests within the competence of the IL are met. If some types of testing activities are not carried out (for example, sampling, development of test methods), then procedures are not developed for these types of activities and the requirements for the implementation of these types of activities do not apply to IL.
2.1. IL must have:
2.2. The head and technical manager of the IL (deputy head of the IL) should be appointed from among the employees of the organization, the work for which is the main one in this organization.
2.3.IL management must guarantee the competence of personnel working with special equipment, conducting tests, evaluating the results and signing documents containing the test results.
The technical manager is fully responsible for the proper technical support of the technical tasks performed by the IL, the accuracy (correctness, precision) of the test results, for compliance with the requirements of safety rules, industrial sanitation, and for ensuring the quality of all work performed.
2.4. It is allowed to combine functions of various specialists (managers) of IL by one employee.
2.5. In the quality management system, IL must provide for a monitoring procedure for the involved specialists and internships upon taking up the post.
2.6. In IL, performing non-destructive testing, the head, technical manager of IL and specialists performing non-destructive testing, evaluating the results and signing conclusions, must be certified in accordance with the requirements of PB 03-440–02.
Specialists of analytical laboratories, electric laboratories, and laboratories for destructive and other types of tests must be certified in accordance with the requirements of the Rules of attestation (certification) of personnel of testing laboratories (SDA–24–2009).
Specialists of electric laboratories performing measurements and tests in existing electrical installations should have an appropriate group for electrical safety.
Certification of specialists in the aggregate should include all types (methods) of tests (control, measurements, analysis) and types of objects that are assigned to the laboratory and are included in its scope of accreditation.
In the absence of independent bodies for certification of personnel for certain types (methods) or test objects, when assessing IL, education, training and assessment of the experience (qualifications) of personnel are checked.
2.7. IL should provide training, professional training, advanced training, measures for assessing experience and, if necessary, certification of personnel, keep a constant record of information about the qualifications, certification, training and professional experience of each employee participating in the tests.
IL should establish the necessary stages of training for each employee, including:
2.8. All IL staff must have job descriptions approved by their IL supervisor that define their job responsibilities and related duties. In the case of the use of new equipment and technologies, changes in the organization of labor, changes in regulatory and legal acts, job descriptions are reviewed in the manner prescribed by the IL. The IL should keep records confirming that staff are familiar with the job descriptions.
2.9. The IL must be assigned persons from among the employees whose work in this organization is the main one, responsible for certain areas of work, in particular for:
3.1. The premises of the IL and the environment when conducting tests outside the premises of the IL should comply with the requirements of methodological documents for testing and the requirements for the operating conditions of testing facilities.
3.2. IL conducting tests using sources of ionizing radiation must have a radiation-hygienic passport (sanitary-epidemiological certificate) and a license to work with sources of ionizing radiation.
3.3. IL, performing field testing, should be able to reliably deliver funds to the facility (in compliance with radiation safety requirements) and provide verification of the testing tools before use after transportation.
4.1. The IL must have organizational, regulatory technical and methodological documents necessary for the work of the IL, including those governing the conduct of tests in the field of accreditation.
4.2. IL must have the following documents:
4.2.1. Organizational documents:
The form of the passport of laboratories of destructive and other types of tests, laboratories performing product tests and electric laboratories is given in appendix 1.
The passport of the IL performing work on non-destructive testing is issued in accordance with the requirements of PB 03-372–00.
Requirements for the content and execution of the Passport of the analytical laboratory are given in appendix 2.
4.2.2. Organizational and methodological documents:
4.2.3. Normative technical and methodological documents for testing objects in accordance with the field of IL accreditation:
4.2.4. Laboratory personnel documentation:
4.2.5. Archive documentation:
4.3. Information about repairs, verifications of existing test means are entered into the registration documents immediately after the test means are handed over for repair or verification; information about new test means are entered into registration documents as they become available.
4.4. At least once a year, the IL passport must be revised for possible changes, which are drawn up in the prescribed manner.
4.5. IL use, as a rule, standardized test methods established by national standards or documents agreed by the executive authorities. Where non-standardized test methods or laboratory developed methods are used, the suitability of the method should be assessed and agreed with the customer. The method can be evaluated in the following ways:
4.6. The IL must have and apply procedures for evaluating the measurement error during testing and analytical control. Methods and procedures for assessing the accuracy of measurements of various physical quantities characterizing the measured properties of the test object are set out in GOST R ISO 5725-1–GOST R ISO 5725-6.
Note. For some types (methods) of testing (for example, non-destructive testing), it is difficult to assess the measurement error due to the significant influence of subjective assessments of test results. In this case, it is recommended to apply standardized test (control) methods, in which the test method itself establishes the limits of the values of the main sources of measurement uncertainty and the form of presentation of test results.
5.1.IL should be equipped with its own test and auxiliary equipment, equipment for sampling, measuring, control and testing instruments, ensuring the ability to perform testing in the field of accreditation.
For carrying out certain types of work, it is allowed to use equipment, materials, accessories and devices belonging to other enterprises, organizations or individuals with the condition of their verification (for measuring instruments) and certification (for test equipment).
5.2. The range of equipment is determined by the current regulatory and methodological documentation for testing, which applies to test objects and (or) types of tests.
5.3.Each piece of equipment, measuring instruments that are available in the laboratory, including test objects (samples for testing), control instruments, must be identified and registered in the IL. Information about equipment and other technical means must be entered in the Laboratory Passport and (or) in the registration document (registration sheet, card).
5.4. Information about the equipment and measuring devices of other organizations and individuals used in the laboratory (leased equipment) must be entered in the passport (form) of the laboratory, including the period during which the IL has the right to use a technical device that does not belong to IL (a contract has been concluded with the owner of the equipment and measuring device).
6.1. All measuring instruments must be verified or calibrated, test equipment certified in accordance with the established procedure.
For international recognition of the results of IL activities and ensuring traceability of measurements, it is recommended to verify and calibrate measuring instruments in organizations that are signatories of the Mutual Recognition Arrangement.
6.2.The IL must have documented procedures for maintenance and checking the technical condition of the test means used (including autonomous power supplies), as well as a schedule for checking measuring instruments and a schedule for certification of test equipment.
Sampling (determination of places, control zones) should be carried out in accordance with the requirements of regulatory technical and methodological documents for testing. The laboratory should have a plan and procedures for sampling. Sampling records should include identification of sampling personnel, environmental conditions, location of sampling and the number of samples taken.
If the documents do not establish a plan and procedure for sampling, then they are agreed with the customer and documented.
Transportation, storage, handling and disposal of samples should be carried out in accordance with the requirements of regulatory and methodological documents for testing.
The IL must have a system for identifying test objects, ensure their storage without changing the quality characteristics.
9.1. Interlaboratory Comparative Tests (ICT).
For types (methods) of tests and test objects, where it is acceptable, ICT is one of the forms of experimental verification of the IL's activities in order to determine its competence during accreditation or to confirm the compliance of the IL with the accreditation criteria during inspection control. ICT is recommended to be carried out for test objects for which it is possible to ensure the homogeneity of test specimens.
Note. It is not recommended to carry out ICT of solid materials that cannot be homogenized, since the heterogeneity of the test object will not allow fulfilling the requirement of identity of the samples used in conducting ICT. ICT are recommended for analytical laboratories.
9.2. If it is impossible or inexpedient to carry out the ICT, other procedures for ensuring the quality of the tests should be planned:
9.3. Общее руководство работами по организации МСИ осуществляет Орган по аккредитации.
9.4. Practical activities for conducting ICT are carried out by authorized bodies: they develop ICT programs, establish schemes for conducting ICT and methods for processing and presenting ICT results, organize and conduct ICT in accordance with the requirements of R 50.4.006.
9.5. The positive results of the ICT are taken into account when making decisions during accreditation and inspection control.
9.6. In case of unsatisfactory results of the ICT, IL, within the time frame agreed with the authorized body that conducted the MCI, develops corrective actions, based on the results of which the Accreditation Body can take the following decisions:
Note. The authorized body must ensure the confidentiality of information in relation to IL who have demonstrated incompetence during the ICT.
Protocols (conclusions) on the test results must contain the following information:
Additionally, the test report may contain:
The form of the test report, as a rule, is established by the methodological documents for testing. The protocols reflect all deviations from the requirements of the methodological documents for testing and sampling (including those made at the initiative of the customer). In the absence of requirements for the registration of test results in methodological documents, the form of their presentation is agreed with the customer.
When conducting tests for the organization's own needs or with the written consent of the customer, the test results can be presented in a simplified form.