Flexible scopes: adjustments for medical laboratories start in February
In August last year, Deutsche Akkreditierungsstelle (DAkkS) first introduced the new “A, B and C” categories for the flexible scopes of accreditation shown in the certificate annexes of accredited testing laboratories. Starting in February, these categories are now also being introduced for medical laboratories. The new category designations replace the previous “III, I and II” categories. They show more clearly than before that the categories build on each other. The goal is to avoid misinterpretation.
Information on the changeover period for medical laboratories
The start date for the changes in the area of medical laboratories is 15 February 2025, after which only the categories “A, B and C” will be used for medical laboratories applying for initial accreditation in accordance with DIN EN ISO 15189: 2024 or applying for an extension that includes flexible scopes for the first time. All certificates issued after the introduction, including annexes, will now use the new category designations for flexible scopes.
With the introduction of the new categories, existing accreditations of medical laboratories will be officially changed to the applicable flexible scope without the need for an additional application. The scope of accreditation previously shown in the annex to an accreditation certificate with so-called basic flexibility (flexible with regard to the version of test methods) will be changed to the new “A” category for flexible scopes. The previously used “I” category will be changed to category “B”, and category “II” will become category “C”. Definitions of the categories can be found in rule document R-15189.
Where there is no evidence of development and validation competence, the change will be shown in the fixed scope in the annex to the accreditation certificate.
What is the purpose of flexibility of the scope?
Flexibility of the scope of an accreditation allows accredited medical laboratories to include new or modified test methods in their scope of accreditation within defined limits and without having to first undergo a new assessment by the accreditation body each time for amendments or extensions of scope. Flexibility is possible only in areas where the necessary competence among personnel and the requisite premises and facilities are available.
The flexible scope is shown in the accreditation information in the certificate annex. This flexibility is already used by the majority of medical laboratories and applications for it can be made to DAkkS provided there are no sectoral requirements to the contrary.
New category designations already defined in the body of rules
DAkkS provided information about the new category designations in June 2024 when it published rule R-15189 on the accreditation of medical laboratories. The presentation of the rules included an announcement that the changeover from the previous designations (III, I, II) to the new categories (A, B, C) will take place at a later date and in stages.
