ISO/IEC 17065 was published in September 2012. This new standard will replace EN 45011 and ISO Guide 65 and will result in the need to implement changes within a Certification Body’s (CB) management system and processes in order to maintain UKAS accreditation in the future. The purpose of this Bulletin is to explain the transition process that UKAS is putting in place to enable the CBs accreditation to be transferred to the new standard within an internationally agreed timeframe. It is important that CBs consider the content of this Bulletin carefully so that we can work towards a seamless transition period culminating in the successful transfer of their accreditation.
It has been agreed by the International Accreditation Forum (IAF) that the transition period will be 3 years. As the new standard was published in September 2012 this means that all Product Certification Bodies will need to have successfully transferred to the new standard by 1st September 2015.
UKAS will be in a position to start assessing to ISO/IEC 17065 from August 2013.
In order to minimise disruption and reduce additional cost it is UKAS’s intention to undertake the assessments for transition purposes with each CB’s scheduled annual visits. From August 2013 to the end of June 2014 the CB will have the option of deciding whether it wishes to proceed directly with the transition assessment or whether to defer this to the following scheduled visit to allow additional time to implement and monitor the effectiveness of the new requirements. If the CB chooses to defer then during any assessment within that time period the UKAS assessment team shall identify where the CB does not currently meet the new requirements in ISO 17065 and shall report these as recommended findings. (These are for information only, and no evidence will be required).
From 1st July 2014 all assessments will be conducted against the requirements ISO/IEC 17065.
In order for a seamless transfer of accreditation to take place it is imperative that all mandatory findings are effectively addressed before the transition deadline. Therefore any action plan for your particular transition must include appropriate time for the submission of evidence, the review of this evidence by the UKAS team, any follow-up actions and evidence review, and time for UKAS to complete its independent decision making process: It is therefore strongly recommended that corrective actions should be received by UKAS by the end of June 2015.
Shortly before each transition assessment the CB will be asked to provide a gap analysis/implementation plan demonstrating how the organisation has implemented the new requirements. This document will be used by the UKAS assessment team during the assessment process to help determine compliance and hence to make a recommendation regarding transition.
Subject to resource availability, Certification Bodies can request additional assessments if they wish to have their transition assessment earlier than the scheduled visit. If this is an option a CB wishes to consider then they should discuss with their assessment manager at the earliest opportunity.
Accreditation Decision and Grant
All transition assessments shall require an independent decision to be made, based upon the recommendation of the assessment team, in order to confirm that accreditation can be transferred from EN 45011 to ISO/IEC 17065: 2012. Actual transfer of accreditation cannot take place until all mandatory findings have been addressed to the satisfaction of the UKAS assessment team, and a final UKAS decision has been made.
Please note that existing accreditation to EN 45011 will remain valid until transition is achieved, or until 1 September 2015.
From August 2013 all initial assessments shall be conducted against the requirements of ISO/IEC 17065: 2012. For new applicants that wish to proceed prior to this date, each individual case will be discussed to agree the most suitable approach.
If a CB wishes to apply for an extension to its accredited scope during the transition period then the CB will need to discuss with their assessment manager the most appropriate version of the standard to be assessed against. If the CB is deferring its transition assessment (see above) then applications for extensions during this period should be considered for assessment against EN 45011. However, once the CB has started to implement an ISO/IEC 17065-compliant system, and particular once UKAS has begun its assessment of this, then such extension assessments should be considered for assessment against ISO/IEC 17065: 2012.
Please Note: No applications for extension to scope will be accepted to EN 45011 after the end of November 2014.
Related UKAS Publications
UKAS publications related to Product Certification are currently being reviewed and any necessary updates are being initiated.
For sector schemes based upon EN 45011, UKAS is discussing the necessary steps with the individual scheme owners.
Should you require any clarification to the above please contact your Assessment Manager, or Kevin Belson – Technical Manager.