The revision of ISO/IEC 17011 “Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies” in 2017 placed more focus on accreditation bodies taking a risk-based approach to the planning and conduct of assessments. Jeff Ruddle, Strategic Development Director, UKAS tells us more.
By Jeff Ruddle, Strategic Development Director, UKAS
The revision of ISO/IEC 17011 “Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies” in 2017 placed more focus on accreditation bodies taking a risk-based approach to the planning and conduct of assessments. UKAS had already, for many years, used a risk-based approach to plan our assessments. Lead Assessors and their teams having the flexibility to decide how frequently over the course of the 4 Year Cycle of accreditation they assessed aspects of the management system, technical activities, and any satellite locations. However, our teams were constrained to conducting their assessments on-site (until the advent of the COVID-19 pandemic) and on an annual frequency.
The most recent version of ISO/IEC 17011 opened up the potential to vary the frequency of assessment and the use of remote assessment techniques. UKAS wanted to use this opportunity to enhance our current risk-based approach. So, in 2019 the UKAS board set a strategic priority to enhance our risk-based approach introducing elements of remote assessing and considering the possibility of varying the frequency of assessment.
During 2019 UKAS conducted research into risk-based approaches used by other accreditation bodies and regulators operating inspection programmes. This research was used to design a project to develop a new risk-based approach which began in 2020. Throughout 2020 the project team worked with assessors and stakeholders from the Asbestos and Medical Laboratory sectors to develop an approach to risk evaluating conformity assessment bodies (CABs) in that sector. This resulted in the development of a risk evaluation matrix and guidance to assessment teams on assessment approach and frequency. In Feb 2021 a pilot of this approach was started in the Asbestos sector. It had been planned to also pilot the approach in the Medical Laboratory sector but the pressure on the sector related to COVID-19 testing means that the pilot has been delayed till later in 2021.
How will risk be evaluated?
The assessment team use the risk evaluation matrix which considers several indicators that draw on data from UKAS, the customer and third parties to evaluate the risk that a CAB presents. Broadly these Indicators fall into four categories – Uncertainty (as a result of change), Historic Performance, Complexity of Operations and External Factors. These indicators are weighted with more weight being placed on those indicators related to the performance of the organisation. Assessment teams provide responses to each indicator which provides an overall evaluation for the CAB. The outcome of this evaluation then guides the assessment team as to whether the CAB should be recommended for; Enhanced, Standard or Reduced Monitoring. Broadly these categories mean:
- Enhanced Monitoring – the CAB is likely to require more frequent assessment and greater use of on-site assessment.
- Standard Monitoring – the CAB is likely to require an annual assessment with a mix of remote and on-site assessment.
- Reduced Monitoring – the CAB is likely to require an assessment less than once per year and greater use of remote assessment.
It is important to remember that in all cases the CAB is still accredited and that the confidence provided by accreditation remains equal for all CABs regardless of approach. The approach to assessment reflects what it is necessary for UKAS to do to ensure that equal confidence is provided to clients and stakeholders of accredited organisations. The risk of a CAB is re-evaluated after each assessment event and the approach can change over the 4 Year Cycle of accreditation.
Current Status of the Project
The approach is currently being piloted with accredited Asbestos laboratories and inspection bodies. Pilots for the Construction Testing and Medical Laboratory sectors are planned for later in 2021 and Management System Certification Bodies, Engineering Inspection Bodies and Environmental Chemistry Testing Laboratories in 2022. These pilots will involve engagement with the stakeholders and customers of each sector communicating the plans to the pilot and involving them in the development of risk evaluation indicators as appropriate.
These pilots will allow UKAS to evaluate the approach and the changes it makes to assessment planning and conduct with an aim of implementing the approach across all areas of UKAS operations by 2024.