Historically, accreditation was defined by accreditation bodies (UKAS in the United Kingdom) in very precise terms and presented as a fixed scope on the schedule of accreditation; this provided an accurate and unambiguous description of the conformity assessment activities (testing, inspection, certification and so on) covered by an organisation’s accreditation.
Over time, however, this model has increasingly become considered as restrictive in that it does not readily enable new or modified activities to be added to a conformity assessment body’s (CAB) scope, even when competence has already been demonstrated in similar or associated areas of expertise.
Although applications for extension to scope can be submitted to UKAS at any time, the standard timescales required for the subsequent assessment and grant of accreditation may not allow the accredited organisation to respond promptly to swiftly changing market needs. Flexible scopes of accreditation provide a mechanism to allow accredited organisations to undertake new or modified activities within their scope of accreditation, even though the specific conformity assessment activities may not be explicitly stated on the schedule. The degree of flexibility can vary between technical disciplines and conformity assessment activities.
Accreditation of a flexible scope inevitably places more responsibility on the accredited body to demonstrate that valid, fit-for-purpose processes and/or activities are undertaken competently, impartially and consistently, and comply with the relevant conformity assessment body standard(s). This does not mean however that an accredited organisation can simply undertake any activity that is requested of it by a client and claim that it is accredited.
The bounds of flexibility in the scope of accreditation must be clearly defined and agreed upon between the accreditation body and the accredited organisation, with the CAB demonstrating to UKAS that it has the competence to work within the full range of its flexible scope, as well as having sufficient resources. Details of the flexible scope will be documented on the schedule of accreditation so that end-users of accredited activities are aware of limitations.
The boundaries will be dependent on the accreditation maintained, but could include flexibility in specific components of an accredited activity, for example:
- area of activity, products, parameters, product/process standards, certifications, materials, schemes, sample types
- range of activity, tests/examinations, technical/clinical areas, clustering of scope IAF codes (or part thereof)
- methods, procedures, parameters, equipment, measurement, extent of technical/clinical area, specification
- type of activities undertaken at a location
- commissioning of new locations
For example, within some technical sectors, accredited organisations may be required to establish temporary facilities or new locations to serve specific customer needs. To allow activities at these locations to be included within the scope of accreditation without undue delay, UKAS can consider the option of awarding accreditation for adding new locations under a flexible scope, where competence in the activities has already been demonstrated at existing locations and the CAB has a fit-for-purpose methodology for setting up such facilities.
Originally, flexible scopes were introduced to improve the agility of accreditation to support testing and calibration laboratories because other conformity assessment body standards already included an element of inherent flexibility. More recently, however, the interest in greater flexibility in areas such as inspection and certification has grown and UKAS has updated its guidance surrounding flexible scopes of accreditation in its document GEN 4 (https://www.ukas.com/wp-content/uploads/schedule_uploads/759164/GEN-4-UKAS-Policy-and-Guidance-on-Flexible-Scopes.pdf) (UKAS policy and general guidance for the implementation and management of flexible scopes of accreditation – Edition 1, October 2019).
Organisations interested in applying for flexible scopes should submit a formal application for an extension to scope (available from the UKAS website www.ukas.com) or contact their assessment manager or firstname.lastname@example.org to discuss whether the flexible scope mechanism is feasible and appropriate for their organisation and activities.