Regulation 6 Amendment to regulation 5

(1)

Regulation 5 (provider requirements) is amended as follows.

(2)

In paragraph (1)—

(a)

for “test provider” substitute “testing service provider”;

(b)

for “meet the following requirements” substitute “be accredited to the relevant ISO Standard^f1 by a signatory to the International Laboratory Accreditation Cooperation^f2 Mutual Recognition Arrangement”;

(c)

omit “that they provide”.

(3)

After paragraph (1) insert—

“(1A)

The relevant ISO Standard for the purposes of paragraph (1) is—

(a)

in relation to sample collection or a point of care test, ISO Standard 15189:2022^f3;

(b)

in relation to a diagnostic laboratory, either ISO Standard 15189:2022 or ISO/IEC Standard 17025:2017^f4.”.

(4)

Omit paragraphs (2) to (7).

Annotations

Footnotes

f1: ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 1 rue de Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland.
f2: International Laboratory Accreditation Cooperation is an international organisation which coordinates the work of its signatory national accreditation bodies which are themselves involved in the accreditation of conformity assessment bodies, testing laboratories, and medical testing laboratories. The ILAC Secretariat, PO Box 7507, Silverwater, NSW 2128, Australia.
f3: ISO 15189 Medical Laboratories requirements for quality and competence which was published in December 2022.
f4: ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories which was published in November 2017.