As the UK’s National Accreditation Body, UKAS is committed to focussing its services on bodies that are established in the UK. However, this does not mean that UKAS does not operate outside of the UK borders as this may be required to meet the demands of UK bodies that also have offices based overseas. In addition, where resource permits, UKAS can accredit bodies in other parts of the world where this does not impact on UK competitiveness, and where strict rules are complied with. UKAS’ approach to this work is covered by its ‘cross-frontier’ policy, which takes into account European and International mandatory requirements and guidelines placed upon accreditation bodies.
Cross Frontier Accreditation within Europe
Within the European regional accreditation group, European cooperation for Accreditation (EA), the rules on cross-frontier accreditation are tightly governed by the European accreditation Regulation: Reg (EC) No. 765/2008. This states that a European conformity assessment body (CAB) seeking accreditation shall do so from the Member State in which it is established. Prior to this Regulation, European accreditation bodies were able to accredit CABs in other Member States, and in certain circumstances this was done. However, the change in requirements led to the European accreditation bodies transferring any accredited CABs based in other Member States to their local accreditation body: A deadline was set for this which concluded at the end of 2014.
Although Reg (EC) No. 765/2008 is very stringent on restricting cross-frontier accreditation within Europe, it does allow exceptions. These can be split into two main categories:
- Where a Member State does not have its own accreditation body, the local accreditation body is not a signatory to the relevant EA multilateral Agreement (MLA), or where the local accreditation body cannot provide the CAB with the accreditation service that it is seeking.
- Where an overseas CAB is part of a corporate group whose Head Office is established in a different Member State: In this instance the local accreditation body of the Head Office can provide a single accreditation to cover all sites as long as they meet the requirements listed below.
The policy on cross-frontier accreditation within Europe is published in EA Publication EA-2/13. This was updated in 2009 to take into account the new requirements in Reg (EC) No. 765/2008 although it introduced a level of uncertainty with respect to Point B above. Following lengthy discussions with the European Commission to clarify the position, additional guidance was published in a Supplement to EA-2/13 in 2013. As a consequence, multiple sites in Member States outside that in which the Head Office is established can only be covered by accreditation where:
- They form part of the same Group legal entity, operating under the same commercial name and logo (NB: The name of the individual legal entities may be slightly different but shall include the commercial name of the organisation);
- They operate under the same management, i.e. same set of persons or organisational entities of the same organisation taking overall responsibility for the accredited activities;
- Local sites operate under the same global quality system: Policies governing accredited activities shall be the same throughout the organisation;
- The Head Office substantially influences and controls their activities;
- The accredited CAB (i.e. Head Office) maintains final responsibility for the activities of local sites – contractual or equivalent legal agreements plus internal management controls must be in place;
- Certificates and reports issued by local sites must be issued under the name, address, logo of the accredited CAB (but may mention the contact details of the local site);
- The accreditation certificate shall only name one entity – the Head Office
- Local sites are to be clearly identified in annex(s) to the accreditation certificate
- Initial and accreditation re-assessment is to be done in cooperation between the foreign and local accreditation body
- Surveillance assessments are to be with or by the local accreditation body
- Local entities cannot reject the involvement of the local accreditation body
If the above criteria cannot be met then the overseas entity will need to apply to its local accreditation body for its own accreditation. UKAS’ compliance with the requirements on cross-frontier accreditation is closely inspected during its EA Peer Evaluations, and it is important that it continues to demonstrate compliance in order to maintain its status as a signatory to the multilateral agreements.
Cross Frontier Accreditation within the Rest of the World
Outside of Europe the requirements on cross-frontier accreditation are not so restrictive. Guidance is provided by the two international accreditation groups: the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF), although the expectation is that members of these two groups shall work within the spirit of the guidance. Therefore, whilst not banning accreditation bodies from offering accreditation to CABs from outside its borders, the accreditation body is fully expected to promote the multilateral agreements of both ILAC and IAF, and to inform interested parties that accreditation should be sought from the local accreditation body, subject to them being signatories to the appropriate ILAC and/or IAF multilateral agreements. Further details on the guidance provided on international Cross-frontier accreditation can be found in IAF Mandatory Document MD12 and ILAC Guidance Document G-21.