Accreditation

To receive accreditation by the Accreditation Authority Association of Analytical Centres “Analytics”, the legal person wishing to have his laboratory accredited (“the Applicant”) shall clearly and unambiguously express his intention and assume certain liabilities.

To do this, the applicant executes:

– Application to undergo primary accreditation;

– Application to undergo accreditation in additional field

– Application to undergo repeat accreditation

–Application to undergo accreditation as producer of standard samples.

Application addressed to the name of the Head of the Accreditation Authority Association of Analytical Centres “Analytics”. It shall be accompanied by:

– Articles of Association of the legal entity

– Provision about laboratory (if the laboratory is a legal entity department);

– Laboratory quality guidelines (or of the producer of standard samples);

– Passport of the laboratory (or producer of standard samples);

– Project in the stated field of accreditation

– Results of participation in programs of Interlaboratory Comparative Tests (form 19).

The application can be declined in the following cases:

– the application does not contain necessary (reliable) information about the applicant;

– the application form does not conform to the model;

– there is no description of the scope of accreditation or accreditation field does not correspond to the activity field of the Accreditation Authority.

Association “Analytics” conducts accreditation works in two stages:

The first stage – examination of the documents submitted by the applicant;

The second stage – on-site laboratory evaluation.

The reason for the start of the accreditation is an agreement concluded between the applicant and Association “Analytics”.

In its work the Accreditation Authority Association of Analytical Centres “Analytics” is guided by the following documents:

– “Policy of the Accreditation Authority Association of Analytical Centres “Analytics” for ensuring quality”;

– GOST ISO/MEK 17011 (ГОСТ ИСО/МЭК 17011);

– GOST ISO/MEK 17025-2009 (ГОСТ ИСО/МЭК 17025-2009);

– Policy of the Accreditation Authority Association of Analytical Centres “Analytics” for ensuring traceability of changes;

When assessing the laboratories, in addition to ISO/MEK 17025, the following standards shall be applied:

– GOST R 53701-2009 (ГОСТ Р 53701-2009) “ Guidelines for the Application of GOST R ISO/MEK 17025 in laboratories applying organoleptical analysis” – for assessment of the laboratories in the area of activity including organoleptics;

– GOST R 52960-2008 (ГОСТ Р 52960-2008) Accreditation of forensic laboratories;

– GOST R ISO 15189-2009 (ГОСТ Р ИСО 15189-2009) “Medical Laboratories . Particular requirements to quality and competence” for medical laboratories;

– Guidelines ILAK-G12:2000 (ИЛАК-G12:2000) Guidelines for assessing the competence of the producers of standard samples.

In accordance with the rules of the Accreditation Authority, the laboratory applying for accreditation is not guaranteed to receive accreditation. The Accreditation Authority reserves the right to refuse to accredit the applicant’s laboratory, if the laboratory does not meet the requirements of GOST ISO / MEK 17025 (ГОСТ ИСО/МЭК 17025), or has failed to demonstrate its competence in carrying out works in the declared area of ​​accreditation.

In cases when the accreditation process of the laboratory includes work on addressing the identified discrepancies, the laboratory must submit corresponding report in the prescribed form.

In case of a positive decision on the accreditation, the applicant receives the accreditation certificate. The Accreditation certificate is issued for a period not exceeding five years, and for laboratory getting accreditation for the first time – not more than 3 years. Accredited laboratories must follow the Policy of the Accreditation Authority Association “Analytics” for prevent incorrect references to accreditation when referencing to the accreditation status.

Accredited laboratory for the duration of the certificate of accreditation must undergo annual inspection of their activities by the Accreditation Authority.

Association “Analytics” provides no applicants any special conditions for accreditation works. Membership in any organizations, form of ownership, organizational features, etc. do not qualify for special treatment during the accreditation process.

Accredited laboratories are entitled:

– to prolong accreditation upon expiration of accreditation certificate providing the accreditation application is submitted in time (3 months before the expiry of accreditation certificate);

– To expand the scope of accreditation field accreditation in the additional field) during the period of validity of the accreditation certificate.

Accredited laboratory can expand its scope of accreditation. For this purpose it is necessary to submit the appropriate application form (Appendix “E” to the RC, p.2).

The decisions of the Accreditation Authority may be appealed by filing an appeal or grievance.

The actions of the accredited laboratories may be appealed by filing a claim in the accreditation authority.