Requirements for testing laboratories

Management requirements

Requirements for the testing laboratory, according to SDA-15-2009 (section 4):

1. Organization

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. Quality Management System.

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:

• management commitment to maintain high quality testing in customer service;
• statement of the level of service provided by the IL;
• quality management system objectives;
• the requirement for IL personnel to familiarize themselves with the documents of the quality management system and comply with their requirements;
• the commitment of the management of IL to act in accordance with this document and constantly improve the effectiveness of the quality management system.

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:

• scope of the quality management system;
• a brief description of the legal status of the IL, including contact information (name of organization, address, phone numbers, etc.), as well as a description of the scope of accreditation and competence of the IL (with links to the charter (charters) of the IL or the organization of which it is a part);
• a description of the structure of the IL or the organization of which it is a part;
• information on IL's relationship with its parent or subsidiary organisations (if any);
• a statement of quality policy that outlines the goals and obligations of the IL in the field of quality;
• records on the appointment of an official authorized to develop, maintain and develop a quality management system;
• records that IL personnel are familiar with the quality manual, quality policy;
• Full Name, data on qualifications, practical experience and authority of the Manager and IL staff, both regular and engaged;
• description of the system of training and advanced training of personnel involved in testing, analysis, measurements;
• job descriptions of personnel involved in testing and registration of test results, defining their duties and responsibilities;
• organizational chart, reflecting the subordination, responsibility and distribution of duties of staff;
• qualification requirements for IL specialists;
• the procedure for the appointment of specialists for testing, analysis, measurements;
• procedure for handling technical means;
• information on the means of control, testing, analysis and technical diagnostics used (including measuring instruments);
• the procedure for organizing and conducting verification and maintenance of measuring instruments and test equipment;
• the procedure for checking the technical condition of equipment after its transportation and delivery to the workplace;
• information about the occupied premises;
• the procedure for conducting tests in the field of accreditation of IL, including the registration of test results and the issuance of conclusions and test reports;
• the procedure for conducting tests in case of a forced deviation from the requirements of the documents in force in the IL;
• the procedure for recording intermediate and final test results and analysis, measures for the protection and restoration of electronic information carriers, including unauthorized access;
• a detailed statement of the documented procedures used during testing and analysis, and their interaction with each other;
• the quality control procedure for the work performed during testing and analysis, the registration of their results;
• the procedure for compiling, recording and storing documents;
• the procedure for recording, maintaining and storing quality system documents;
• description of the information support system;
• document management procedure, which includes: checking documents for sufficiency prior to their release; analysis and updating as necessary and reapproval of documents;
• providing identification of changes and revision status of documents;
• ensuring the availability of appropriate versions of documents in places of their application;
• ensuring the safety of documents clear and easily identifiable;
• providing identification of documents of external origin and managing their distribution;
• preventing the unintended use of obsolete documents and apply appropriate identification of such documents left for any purpose;
• list of counterparties
• the procedure for the consideration of appeals, claims, complaints, disputes;
• the procedure for the internal audit of the activities of IL, the procedure for developing a plan of corrective and preventive actions and the organization of their conduct;
• the procedure for reviewing the quality system and analysis by management;
• the procedure for suspension (termination) of activity in the event of suspension (cancellation) of the certificate of accreditation;
• a description of the system for ensuring impartiality and independence in conducting testing;
• confidentiality procedure;
• a list of IL units (specialists) for distribution of the Quality Manual.

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.

3. Documentation management

The IL should develop and maintain documentation management procedures that include:

• procedure for approving and issuing documents;
• the procedure for compiling, accounting and storing documents IL;
• the procedure for accounting, maintaining and storing quality system documents;
• description of the information support system;
• list of available documentation;
• checking the completeness of the requirements of the documents by an authorized employee;
• analysis and updating (making changes) as necessary and reapproval of documents;
• providing employees with appropriate copies of documents at the workplace;
• ensuring that documents are kept clear and easily identifiable, including when reviewing documents;
• ensuring registration of external documents;
• preventing the unintended use of obsolete documents and the use of appropriate identification of such documents left for any purpose.

4. Test Request Analysis

The IL shall establish and maintain procedures for the examination of applications for tests that guarantee:

• test methods and objects are included in the field of IL accreditation;
• IL has the appropriate test methods, including sampling methods that meet customer requirements. The use of non-standard methods must be agreed with the customer;
• The IL has appropriate testing equipment and testing facilities (testing facilities can be provided by the customer, which must be documented);
• any change in the contractual conditions for testing revealed during the work is agreed with the customer.

5. Conclusion of Subcontracting to the test

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. Acquisition of services and stocks

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. Interaction of IL with customers

7.1. IL must collaborate with test customers (ensuring confidentiality with other customers). Cooperation can be carried out in the following:

• providing the customer with the opportunity to monitor the tests;
• transfer to the customer of packaged, labeled samples that have passed the test;
• informing the customer about the progress of the tests.

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.

8. Review of claims

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.

9. Management of tests that do not meet established requirements

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:

• actions are immediately taken to establish the causes of non-conformities, and if necessary, the tests and the issuance of test reports are suspended;
• assessment of the significance of nonconformities
• corrective actions are taken with the adoption of a decision on the use of test results obtained during operations that do not meet established requirements;
• if necessary, the customer is notified and the test results are canceled;
• a responsible person is appointed for making a decision on the resumption of testing.

10. Quality Management System Improvement

IL must constantly improve the effectiveness of its quality management system, using:

• quality policy and goals;
• results of internal and external audits, data analysis, corrective and preventive actions, analysis by management.

11. Corrective action

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.

12. Warning actions

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. Record management

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.

14. Internal audit

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.

15. Analysis from the management

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:

• relevance of the policies and procedures of the quality management system;
• results of internal audits;
• instructions from governing and supervisory authorities;
• effectiveness of corrective and preventive actions;
• the results of interaction with customers, suppliers, subcontractors, other organizations, as well as the analysis of complaints and claims;
• the results of interlaboratory comparative tests and proficiency testing of personnel.

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.

Technical requirements

Requirements for the testing laboratory, according to SDA-15-2009 (section 5).

1. General requirements

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. Staff requirements

2.1. IL must have:

• the head of the IL, who is fully responsible for the organization of the tests;
• Technical Manager of IL (Deputy Head of IL);
• personnel with appropriate professional training, theoretical knowledge and practical experience necessary for the performance of tests.

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:

• period of official inauguration;
• the period of work under the supervision of experienced employees;
• ongoing training throughout the career.

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:

• storage, maintenance, operation and metrological support of testing (measurement) means;
• the functioning of the quality management system;
• maintaining a fund of normative technical and methodological documentation;
• maintaining and storing documentation on test results;
• radiation safety, accounting and storage of ionizing radiation sources.

3. Premises and environmental conditions

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. Test methods, assessment of suitability of methods

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:

• constituent documents of the organization (enterprise);
• passport IL.

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:

• Quality quide;
• registration documents for testing facilities;
• operational documents for the testing tools that are included in the delivery kit (passport, instruction manual, documents for maintenance, repair, etc.);
• documents confirming the competence of suppliers of test equipment and organizations providing laboratory services;
• Schedules of verification of measuring instruments and maintenance of testing instruments;
• certificates of metrological verification (calibration, certification).

4.2.3. Normative technical and methodological documents for testing objects in accordance with the field of IL accreditation:

• regulatory documents that regulate technical requirements for test objects and establish quality indicators (status) of these objects, as well as specific types (methods) of testing these objects;
• international and national standards and methodological documents, which determine the types of tests of objects assigned to the laboratory, establish the main test parameters, give schemes and general requirements for testing;
• Test programs and methods and other documents regulating the procedure of conducting (technology) tests, sampling of specific objects with specific types of tests.

4.2.4. Laboratory personnel documentation:

• job description;
• materials on certification of laboratory staff (copies of qualification certificates).

4.2.5. Archive documentation:

• instructions on how to maintain the archive;
• journal of registration of archival documents.

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:

• calibration using validated standards and reference materials;
• comparison of the results obtained by other types (methods) of tests;
• interlaboratory comparative tests;
• evaluating each factor that affects the test result;
• theoretical calculations confirming the test result and the error.

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. Equipment

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. Traceability of measurements

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.

7. Sampling (samples)

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.

8. Handling test objects

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. Test quality assurance

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:

• the use of control samples in IL, calibrated (certified) according to the general in the Unified System of Assessment of Conformity to Requirements; for analytical laboratories - standard and control samples;
• application in IL of methodological and regulatory documents common to the Unified Conformity Assessment System, establishing the test methodology and product quality; for analytical laboratories – metrologically certified methods of quantitative chemical analysis (for non-certified methods, the error characteristics are calculated in accordance with the requirements of GOST R ISO 5725 and MI 2335-2003);
• carrying out activities to assess the experience of personnel;
• registration based on control results, unified conclusions and protocols that allow tracking procedures and reproducibility of control results;
• certification of personnel in independent certification bodies of the Unified Conformity Assessment System, in which personnel control identical test samples, that is, in fact, a coded experiment is carried out to determine the defectiveness or characteristics (properties) of samples;
• duplication of tests in IL;
• quality assessment of samples and products by different types (methods) of control;
• duplication of tests using the same methods and repeated tests of preserved objects.

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:

• in case of satisfactory results of the implementation of corrective actions, confirmed by the authorized body, the validity of the accreditation certificate is preserved (or the accreditation procedure continues) and the IL is assigned a period for repeated ICT (as a rule, with completion by the next inspection control);
• in case of doubts about the results of the implementation of corrective actions, confirmed by the authorized body, repeated ICT are appointed, with completion by the set deadline, but not later than the decision on accreditation or the decision on the results of the inspection control;
• in case of unsatisfactory results of corrective actions within the established time frame or unsatisfactory results of repeated ICT, a decision is made to temporarily suspend the validity of the IL accreditation (until the implementation of corrective actions and the inspection control of the IL) or to cancel accreditation by types (methods) of tests for which unsatisfactory ICT results were obtained.

Note. The authorized body must ensure the confidentiality of information in relation to IL who have demonstrated incompetence during the ICT.

10. Test reporting

Protocols (conclusions) on the test results must contain the following information:

• name and address of the IL (indicating the location of the tests, if they were carried out outside the laboratory);
• identification of the test report with numbers on each page of the report and the total number of pages;
• name and address of the customer;
• identification of the test method used;
• description and identification of the test object;
• the date of testing (if necessary, the date of sampling or receipt of the test object is indicated);
• reference to the sampling plan and methods (if this affects the inaccuracy of the test);
• test results;
• name, position and signature of persons who conducted the tests and approved the test report.

Additionally, the test report may contain:

• deviations, additions or exclusions related to the test method or environmental conditions;
• indication of compliance / non-compliance of the test object with the established requirements;
• measurement error;
• additional information (fulfillment of the terms of the contract, recommendations for using the results and improving the test object).

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.