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Laboratory accreditation. Federal Accreditation Service. Accreditation system in the Russian Federation

Accreditation of testing laboratories in the Russian Federation is carried out once every 3-5 years. Authorized structures participate in the procedure: Gosstandart, tax service, SES. The preliminary testing laboratory is checked by a special department of the Ministry of Internal Affairs, labor and fire inspections. During the events, readiness for product analysis and other positions are assessed. In accordance with the results, a laboratory accreditation certificate is issued. laboratory accreditation

Objectives of the procedure

Why is laboratory accreditation necessary? The requirements for these institutions are quite stringent today. This is due to their role in the quality management system of finished products. The testing laboratory is a regulatory organization. It should ensure the accuracy of the analysis, quality monitoring of technological processes at each stage of production.

Standard

Accreditation of testing laboratories is carried out in accordance with the procedure established by the Federal Service. The standard is used directly by participants in this procedure. In particular, it is used by the laboratory accreditation body. This structure not only carries out a direct audit of the institution, but also subsequent control over its activities. The standard is used by the chemical laboratory itself. It is necessary at the stage of creating the institution, passing the audit. In addition, it is important for the effectiveness of the laboratory. The scope of accreditation in this case acts as the basis for its implementation.testing laboratory accreditation

Criteria

The federal service that performs accreditation has the right to establish special (additional) standards and norms. They are used to confirm the independence and technical competence of the institution. Special criteria are determined by specific types of tests. These standards should be published (formally established) or made available to interested parties upon request.

Institutional Responsibilities

The chemical laboratory must do the following:

  • To comply with the standards established in the Russian Federation GOST R ISO / IEC 17025 and the adopted standard, as well as comply with other criteria provided by the regulatory structure.
  • Form the necessary conditions for the implementation of inspection control, accreditation for the next period, and acceptance of complaints. In addition, authorized persons should be provided with access to the necessary documentation, employees and other sectors related to the institution.
  • Declare conformity verification solely regarding activities within the scope of accreditation of the testing laboratory.
  • Do not use the results of the procedure to the detriment of the reputation of the inspection body.
  • Do not make statements regarding accreditation capable of mislead consumer.
  • Do not make any statements if the laboratory accreditation has been suspended or canceled. All documents issued by an authorized entity must be returned upon request.

chemical laboratory

Laboratory Accreditation Area

It should be clearly defined by the list of product types and tests in accordance with the requirements of regulatory and other documents.To implement this provision, it is necessary to establish, as far as possible, the most accurate definitions of the procedures carried out, indicating the goods, services, works, properties and methods used.

The area of ​​accreditation is drawn up in a separate paper of the established form and acts as an annex to the final document. The methods that are used in accordance with it for each specific test are determined in accordance with the standard or other regulatory acts or based on a documented procedure. Accreditation of the laboratory is carried out exclusively in relation to certain activities in non-stationary or stationary conditions.

Request

It must reflect:

  • Awareness of the rules of procedure.
  • Declared area.
  • Willingness to complete the procedure, including paying the costs that will relate to work (regardless of the outcome) and subsequent inspection control, to accept a commission.
  • Confirmation of consent to fulfill requirements related to accreditation.

The application may contain a proposal to appoint an expert or institution to analyze documents on the ongoing procedure. The paper must be accompanied by a pact of documents containing information necessary and sufficient to determine the readiness of the laboratory for accreditation. The exact list of required securities is established by the authorized structure. The applicant is given the opportunity to familiarize himself with the description of the procedure, as well as with the item of expenses that he will pay. testing laboratory

Laboratory accreditation in the Russian Federation: procedure

The procedure consists of the following steps:

  • Submission of application.
  • Examination of documents.
  • Certification.
  • Analysis of materials after the necessary activities and decision making.
  • Registration, execution and issuance of a certificate with the attached package of documents.

Information provided

They are submitted with the application. The laboratory must provide:

  • General information about the institution. These data are usually given in copies of the charter or in other constituent papers, regulations, passports. These include, in particular:
  1. address;
  2. name;
  3. location of units (if they are located in different territories);
  4. technical means;
  5. staff;
  6. legal status.

laboratory accreditation area

  • General information about the structure of the laboratory. Among other things, they indicate the scope of activity, authority and competence, interactions with other organizations. This information is usually included in the Regulation on the institution or in the certificate of the type of activity, which provides information on technical and practical experience, as well as on participation in qualification checks.
  • Description of the control system and internal structure, the form of the test report, which is issued after the accreditation is passed.

Document Examination

It is conducted by an authorized employee or organization. There may be several experts. In this case, a leading specialist is appointed. The results of the examination are reflected in the conclusion. It should contain an assessment of the conformity of documents provided to applicants with accreditation criteria. The conclusion is fixed by the signature of the expert or authorized person from the organization.

Result

In the case of a negative assessment, the inspection body may refuse accreditation. This decision is brought to the attention of the applicant. He, in turn, can make corrections and modify the paper, and then provide them for re-examination.

In case of a positive result, the accreditation body forms a special commission, which conducts the certification of the applicant. She also approves the procedure for his further work, drawn up in accordance with the model program.The commission includes metrologist, experts, as well as (if necessary) representatives of the accreditation body and authorized employees of other structures.

laboratory accreditation body

Timing and analysis of materials

The period during which certification of the laboratory will be carried out must be agreed with the applicant. The names of the members of the commission are informed in advance. The applicant has the right to protest the appointment of one or another specialist or expert.

The accreditation service analyzes the application, the information provided by the laboratory and collected during the examination, the act of the procedure, documentation confirming the elimination of non-conformities (if any), and other information that was obtained during the events. In accordance with the results, a decision is made. It can be positive or negative.

Final stage

In the case of a positive decision, the accreditation service carries out registration and registration, as well as the issuance of an accreditation certificate. The agreed position and passport of the institution are attached to it. A document on the area of ​​accreditation is also issued. The decision is made within six months from the date of application. The certificate establishes its validity. In the case of the initial procedure, it will be no more than three, in the case of repeated - no more than five years.

Inspection control

An accreditation service and a testing laboratory that has passed certification should inform each other of any changes that could cause the institution to not meet the current criteria. Inspection control involves internal audits that are carried out directly by the organization itself, as well as the supervision of an authorized structure. These activities are carried out throughout the validity period of the certificate in the form of a systematic analysis of information about the activities of the laboratory, regular and (if necessary) unscheduled inspections. In case of violation of the conditions, the authorized structure may suspend the validity of the issued permit document or withdraw it. laboratory accreditation requirements

Additional area

If necessary, the applicant may send a new application to the authorized structure. It indicates an additional accreditation area, drawn up in accordance with the established procedure, as well as other documents that have been amended. If the application is submitted for verification of a technical unit that has not previously gone through the procedure, then the work in this case is carried out in full. Accreditation for an additional area may be conducted in an abbreviated manner. The possibility of its application is determined by an authorized inspection structure in each individual case. When making a positive decision, the accreditation body approves the supplement, carries out its registration and transfers it to the applicant.

New term

Re-accreditation is carried out by the time the certificate expires. An application must be submitted at least six months before this date. Accreditation for a new term is allowed to be carried out according to the shortened procedure, taking into account the results of the inspection control in accordance with the decision of the authorized body.


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