Regulation (EU) 2018/858 and its impact on Approval Authorities and Technical Services
Updated: Jan 28, 2021
What is the impact for Approval Authorities and Technical Services?
The changes introduced by the new Regulation (EU) 2018/858 do not just impact manufacturers; they are going to result in a new way of working for Approval Authorities and Technical Services too.
It is clear from the new requirements that the European Commission believes there should be greater control over the operation of Approval Authorities and the operations and designation of their Technical Services to guarantee the independence of these parties and prevent conflict of interest. The regulation also introduces safeguards in an attempt to prevent approvals being granted incorrectly and abuse of the process.
For the Approval Authorities, responsible for type approvals in their state, the biggest change comes in the form of periodic assessments by the Commission. The assessments which will take place every five years will include the evaluation of a random sample of approvals issued in that period. The frequency can be reduced or extended beyond a five year period based on the results of the first assessment. The Commission will fund any assessments and will operate in accordance with the laws of the member state acting proportionately and confidentially. A summary of the outcome of each assessment will be made publicly available.
In a similar vein, Technical Services, the organisations appointed by Approval Authorities to carry out the testing or witnessing, will come under greater scrutiny. In terms of designation and monitoring of Technical Services, the intention of the Regulation is seemingly to push Technical Services towards accreditation to ISO 17025, where testing is conducted in their own laboratories (Category A) and accreditation to ISO 17020, where the Technical Service supervises the testing at a third party or manufacturers’ premises (Category B). This is not mandatory, but if the accreditation is not obtained from a national accreditation service (UKAS in the case of the UK) then there is added scrutiny placed on both the Technical Service and the Approval Authority appointing them.
Where Approval Authorities are assessing their Technical Services and not relying on an accreditation, this activity is subject to peer evaluation by a team from two other Approval Authorities every five years. A summary of the findings will be made publicly available by the European Commission.
The assessment of Technical Services is valid for five years and the Approval Authority must perform an on-site assessment at least every 30 months to verify that requirements continue to be satisfied and quality maintained. A summary of the findings will be made publicly available.
Regardless of the assessment option taken, there in an increased focus on the need for Technical Services to be able to demonstrate independence and prove competence for all relevant activities. There are also new requirements for instances where testing is conducted by subsidiaries or sub-contractors.
Notably, the current requirement for a bilateral agreement to exist between the Union and a third-party country (as the UK will be on 1st January 2021), if a Technical Service is to be designated there remains. I will look at Brexit impacts in more detail in a few months time as we near the end of the transition period.
Castec Consulting Limited an independent Type Approval, Certification and Compliance consultancy.
We provide specialist services, predominantly in the automotive sector, for companies in the UK and globally seeking assistance in a range of areas including; Type Approval and Compliance, Vehicle Technology and Safety Research, plus the interpretation of automotive legislation.