Regulation 5 Provider requirementsI1

England and Wales

(1)

A F1testing service provider must F2be accredited to the relevant ISO Standard by a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement in respect of any applicable test F3....

F4(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;

(b)

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

F5(2)

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(3)

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(4)

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(5)

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(6)

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(7)

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Annotations

Textual amendments

F1: Words in reg. 5(1) substituted (1.1.2024) by The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 6(2)(a) (with reg. 9)
F2: Words in reg. 5(1) substituted (1.1.2024) by The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 6(2)(b) (with reg. 9)
F3: Words in reg. 5(1) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 6(2)(c) (with reg. 9)
F4: Reg. 5(1A) inserted (1.1.2024) by The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 6(3) (with reg. 9)
F5: Reg. 5(2)-(7) omitted (1.1.2024) by virtue of The Health Protection (Coronavirus, Testing Requirements and Standards) (England) (Amendment and Transitional Provision) Regulations 2023 (S.I. 2023/1340), regs. 1(1), 6(4) (with reg. 9)

Commencement

I1: Reg. 5 in force at 17.12.2020, see reg. 1(1)