The training entitled “Flexible scope (testing and medical labs)” was organised in Athens in the period between 29th and 30th September 2015 as part of the activities of the PTB project “Promotion of regional cooperation in South East Europe in the field of quality infrastructure”. The training was delivered by ESYD employees. ESYD’s experiences and other NABs’ experiences in the accreditation of flexible scope were presented on this occasion. The training was attended by the representatives from Serbia, Croatia, FYR of Macedonia, Montenegro, Albania, Bosnia and Herzegovina, and Kosovo*.
Documents of the European co-operation for Accreditation, EA (EA-2/15 M:2008, EA Requirements for the Accreditation of Flexible Scope) and of the International Laboratory Accreditation Cooperation, ILAC (ILAC-G18:04/2010 Guideline for the Formulation of Scopes of Accreditation for Laboratories) were presented in detail during training as these documents contain requirements and recommendations as regards accreditation of flexible scope. Requirements of ISO/IEC 17025 (clauses 5.4.3 and 5.4.4) and ISO 15189 (clauses 5.5.1 and 5.5.3) pertain to the flexible scope of accreditation.
It is known that accreditation is used to confirm the competence of laboratories to provide reliable services within the defined scope of accreditation (fixed scope of accreditation). However, if accredited conformity assessment bodies (CABs) have a need to introduce new activities in between two surveillance assessments, they are allowed, on the basis of competence confirmed in the previous accreditation period, to change the scope of accreditation within specific measurement principles, whereas a laboratory is allowed to independently manage a part or entire scope of accreditation within defined limits if introduced changes will be assessed during the next surveillance assessment or reassessment. This is co called flexible scope of accreditation.
A flexible scope of accreditation initiative must come from a CAB. Furthermore, a CAB must propose a field and type of flexibility of the scope of accreditation (within test item, properties to be measured/parameters and testing procedures within fields of testing and testing techniques for which the accreditation had already been granted). The accreditation body will decide whether a CAB’s request can be accepted. Moreover, the accreditation body can decide when a CAB can apply for the accreditation of flexible scope for the first time (ATS defined that this can happen during the second surveillance assessment at the earliest).
CAB acceptance criteria for accreditation of flexible scopes are as follows:
- acquired trust in laboratory competence;
- frequency of introduction of new substrates, new testing methods, modification of methods or method performance, and activities pertaining to new versions of standards;
- field of testing/calibration for which professional organisations recommend the use of flexible scopes (e.g. medical examinations, testing of pesticide residues in food, water, soil – due to the use of new substances in agriculture; testing of athletes – “doping control”; medicine testing in national official medicine control laboratories (OMCLs); testing of genetic modifications of plants and plant products - GMOs); forensic testing of human gene loci, etc.);
- authorisation of conformity assessment bodies.
Flexible scope of accreditation can be formulated “concisely” as per the NAB in-house document.
Moreover, a CAB must have an in-house List of Activities containing all elements of fixed scope of accreditation and this List shall be updated by an authorised CAB person in case of all new activities within specific measurement principles. In addition to the aforementioned, this List needs to contain at least a short description of the change, date when the new activity became valid and a reference to a validation/verification report on the testing method. All the changes to the List of Activities must be clearly marked. The List of Activities must be made available to an accreditation body, clients and interested parties. The accreditation body must have a policy on possible modes of making the List of Activities public. One of the modes for making the List of Activities public is posting thereof on the CAB website.
Ljubinka Gligić PhD and Jelena Stojanović attended the training on behalf of the Accreditation Body of Serbia (ATS) when they informed the present participants that ATS had defined its policy on the accreditation of flexible scope and prepared the guidance document entitled Accreditation of Laboratories for Flexible Scope of Accreditation ATS-UP28.
In May 2015, ATS granted the first accreditation for the flexible scope of accreditation to the Centre for Medical Biochemistry (CMB) of the Clinical Centre of Serbia (KCS). CMB documented all activities necessary for managing the flexible scope of accreditation which implied introduction of new substrates, new parameters and testing procedures within existing accredited fields of testing, testing techniques and human material. “SP Laboratorija” a.d. Bečej was granted the flexible scope of accreditation thereafter in the field of testing of pesticide residues in food and feed for the types of testing/properties to be tested/measured and reference document, including testing of genetic modifications of plant material and its presence in technologically processed products (qualitative and quantitative PCR techniques).
*This designation is without prejudice to positions on status, and is in line with UNSCR 1244 and ICJ Advisory opinion on the Kosovo declaration of independence