New accreditation criteria and requirements for accreditation bodies in Russia have been approved
On November 16, 2020, the Order of the Ministry of Development of Russia No. 707, entitled "On the approval of the accreditation criteria and the list of documents confirming the applicant/accreditation body's compliance with the accreditation criteria" was published. The accreditation criteria clearly define the set of requirements that the applicant / accreditation body is obliged to meet in the national accreditation system in order to perform accreditation activities. The changes introduced by the document are effective from 01/01/2021, with the exception of some provisions that will enter into force at a later date.
Changes from July 1, 2021 for certification bodies
For certification bodies, the following provisions will change from that date:
- requirements specifying the requirements as to the professional experience of the employees of certification bodies (paragraph 3, point 4.1)
- requirements for the head of the certification body and his deputies (paragraph 3, point 4.2)
- requirements for employees involved in the performance of work related to the conformity assessment procedure (point 4.3)
- requirements for bodies that certify products, the confirmation of compliance of which is carried out in accordance with the national legislation and standards of the Russian Federation (point 7)
- requirements for production certification bodies, which are subject to mandatory confirmation of product compliance with the requirements of the technical regulations of the Customs Union / Eurasian Economic Union (point 8).
Additional requirements for organic product certification bodies (clause 9) and additional requirements for service certification bodies (clause 10) (to be applied on a voluntary basis) were also introduced.
Changes for research laboratories from July 1, 2021
The update of the criteria has also affected the research laboratories that participate in the accreditation processes. The most important provisions that are subject to change are:
- requirements for the place of performance of activities in the scope of accreditation, including the place of temporary work (point 24.4, section 2). Pursuant to this provision, an employee may be employed in only one research laboratory
- requirements for managers and deputy heads of laboratories conducting research on products in the railway industry (point 220.127.116.11)
- document requirements, the records of which must be completed by a given laboratory (paragraphs 2 and 3 of point 23.2).
Inspection authorities and entities ensuring uniformity of measurements will also face the changes
From July 1, 2021, the provisions on inspection authorities will also change. It concerns two entries:
- requirements for the unit's staff, manager and deputy head of the inspection body (subsections one and three of subsection 29.2)
- requirements for the seat and place of operation of the inspection body (second paragraph of point 29.5)
Point 43 regulates the changes that will include entities ensuring uniformity of measurements in the certification process at its various stages. They relate to general accreditation criteria and establish requirements for the property and use of premises, equipment, measuring instruments and reagents.
Other changes will enter into force on January 1, 2022
The last important element of the ordinance are the regulations that will enter into force on January 1, 2022 and will be in force until January 1, 2027. It is about:
- accreditation criteria for management system certification bodies (points 12-16)
- document requirements to be met by the personnel certification body (point 18)
- accreditation criteria for bodies involved in greenhouse gas validation and verification (paragraphs 31-35).
- GOST R ISO 15189-2015
Amendments to the law on certification criteria from 01/01/2022 will also cover the rules for laboratories conducting biological, microbiological, immunological, chemical, immunohematological, hematological, biophysical, cytological, histopathological, genetic or other testing of materials derived from the human body in order to obtain information for the diagnosis, prevention and treatment of disease or human health assessment. Such laboratories, instead of GOST ISO / IEC 17025-2019 from January 1, 2022, will apply the standards GOST R ISO 15189-2015 "Medical laboratories. Detailed quality and competence requirements ”.