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General requirements to the competence of testing and calibration laboratories

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General requirements to the competence of testing and calibration laboratories

According to a joint decision of ISO (International Organization for Standardization) and ILAC (International Laboratory Accreditation Cooperation), the international standard ISO/IEC 17025-2017 was enacted in November 2017, for which a transition period of 3 years was set, that is, until November 2020, after which the standard ISO/IEC 17025-2005 (State Standard ISO/IEC 17025-2009) is canceled.

In the Republic of Kazakhstan over 1300 subjects of accreditation (testing, certifying and calibration laboratories) are accredited for compliance with State Standard ISO/IEC 17025-2009 (identical to ISO/IEC 17025-2005).

In accordance with the aforementioned ISO and ILAC decision, all those accredited under the ISO/IEC 17025-2005 standard by November 2020 must transit to a new version of the ISO/IEC 17025-2017 standard.

Since the international standards of ISO are not directly applied in the Republic of Kazakhstan, it is necessary to develop an intergovernmental standard within the framework of the Interstate Council for Standardization, Metrology and  Certification, or a national standard in order to implement a joint ISO and ILAC decision.

In connection with this need from November 20th, 2018, the standard ST RK ISO/IEC 17025-2018 “General requirements for the competence of testing and calibration laboratories”, identical to the international ISO/IEC 17025-2017 was put into effect on the territory of the Republic of Kazakhstan.

During the transition period, accreditation certificates for compliance with the requirements of standard ISO/IEC 17025:2009 and standard RK ISO/IEC 17025:2018 standards have the same legal force.

From December 1st, 2020, all accreditation certificates confirming competency for compliance with the requirements of State Standard ISO/IEC 17025:2009 are considered invalid.

Assessments planned for the period after June 1st, 2018 (inspection, re-accreditation, extension of accreditation area, change of location) can and should be used to move to standard RK ISO/IEC 17025:2018.

Three months before the planned assessment of the laboratory, it is necessary to submit to the NCA (National Center of Accreditation) an approved transition plan and documents of the laboratory management system with changes for examination.

In order to guarantee the timely issuance of an accreditation certificate, an assessment of standard ISO/IEC 17025:2018 must be completed no later than May 31st, 2020.

In preparation for the assessment, the laboratory should perform the following actions:

  • external training of key employees on the standard RK ISO/IEC 17025:2018;
  • preparation and approval of a plan for the implementation of the standard RK ISO/IEC 17025:2018 based on a comparison of the new and old standards;
  • implementation of approved measures;
  • making changes to the laboratory management system;
  • submission of the application (transition plan) with the application of updated documented procedures of the laboratory management system, in the NCA for assessment of compliance with the standard RK ISO/IEC 17025: 2018.

To transit to an updated standard, laboratories will need to do a considerable amount of work, including employee training, a review of the laboratory management system, and an audit of new requirements. However, it should be remembered that the transition to the updated standard, adapted for the Republic of Kazakhstan, will allow testing and calibration laboratories to improve their work and make their activity more efficient.

 

 

Head of the licensing and metrology department of "MedExpert",

Yerdaulet Utepov

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