Regulation 15 Withdrawal of quality system approval

(1)

If it appears to a notified body which approved a quality system under regulation 14 that the person to whom it was issued—

(a)

has failed to implement the approved quality system; and

(b)

is unable or unwilling to effect a sufficient remedy,

the notified body may withdraw the approval after giving the person to whom it was issued the opportunity of making representations within a reasonable period as to why it should not be withdrawn.

(2)

Where the notified body, having considered any representations made under paragraph (1) above, withdraws a quality system approval, it shall, in writing,—

(a)

inform the person to whom it was issued and the Secretary of State of the withdrawal of the approval and of its reasons for the withdrawal; and

(b)

inform all other notified bodies of its withdrawal.