SEE QI Project 6 (Harmonization of Accreditation with European rules) completed, impact evaluated

On 18 November 2021 the contact persons from WB6 ABs came together for a last final wrap-up meeting with the PTB project management and the PTB accreditation expert.

Objective of the meeting was – amongst others – to receive feedback from the ABs, in how far the implemented trainings and exchange of experience formats have contributed to concrete changes or innovations in the ABs practice and documented processes. The following impacts have been reported by WB6 ABs:

  • Definition and application of competence criteria for assessors in different accreditation schemes (and a better understanding of the requirements of ISO 17011(2017) in general) has resulted in a better preparedness and reduction of observations and non-conformities in EA peer evaluations
  • Resulting from the exchange of experience workshop on implementation of risk based approach in line with ISO 17011(2017), ABs have updated their Risk register with identification and treatment of new risks
  • WB6 ABs have started to conduct remote evaluations in order to respond to the new situation arising from the COVID-19 pandemic
  • WB6 ABs have increased their assessment capacities for medical laboratories (SARS-CoV-2 identification) and testing laboratories (sampling, decision rules, opinion and interpretation….)
  • Benefiting from the hands-on training and published Guideline, ATCG of Montenegro has accredited the first medical laboratory according to ISO 15189 performing In vitro medical testing: Sampling for SARS-CoV-2 laboratory diagnostics, Real-time PCR detection of corona virus SARS-CoV-2.
  • The guideline on accreditation of medical laboratories for molecular test of Covid-19 has been published by ABs and is used also by regulators as best practice in this field

Resulting from the exclusively virtual implementation of the project activities, a significantly higher number of participants could attend the virtual formats. External stakeholders like technical assessors, technical experts and personnel of CABs could also attend the virtual formats, whilst previously the limited seats in physical regional meetings were reserved to the classical target group of employees of the ABs. Regional on-site formats would have provided only 132 (based on 2 project-financed participants/AB in each regional meeting) compared to the above observed 333 attendees the chance to benefit from the regional training or exchange of experience formats. Additionally, in classical on-site capacity development formats, about the same time that was dedicated to attend the event had to be spent in travel time for the transportation to and from the meeting venue. Therefore and enormous amount of effective working time has been made available for other purposed, by not travelling to on-site meetings.

The PTB project management would like to thank the contact persons of the WB6 ABs and involved experts for their excellent cooperation.

More information on this project can be found in the SEE QI 6 final report under