Ill. Admin. Code tit. 35 § 186.125

Current through Register Vol. 48, No. 49, December 6, 2024

Section 186.125 - Accreditation

a) Primary Accreditation. The Agency shall issue initial or renewal primary accreditation if the laboratory has met the following criteria:

1) completed the application process as specified in Section 186.130;

2) paid the fees required by 35 Ill. Adm. Code 185;

3) employs qualified personnel, as required by the TNI Standard;

4) implemented and maintains a quality system, as required by the TNI Standard;

5) successfully analyzed proficiency testing samples, as required by this Part and the TNI Standard;

6) passed an on-site assessment, as required by this Part and the TNI Standard; and

7) implemented corrective action detailed in a corrective action report, if any.

b) Secondary Accreditation. The Agency will issue initial or renewal secondary accreditation if the laboratory has met the following criteria:

1) completed the application process as specified in Section 186.130;

2) paid the fee required by 35 Ill. Adm. Code 185; and

3) submitted evidence of primary accreditation from a NELAP accreditation body.

c) Laboratory accreditation issued pursuant to this Part is valid for one year and may be renewed on an annual basis.

d) When an accredited laboratory has made a timely and complete application for the renewal of accreditation pursuant to this Section, the existing accreditation shall continue in full force and effect until the final Agency decision on the application has been made, unless a later date is fixed by order of the Board or a reviewing court. An application will be considered timely only when received by the Agency prior to the expiration of the laboratory's accreditation.

e) Accreditation remains in effect until:

1) suspended or revoked by the Agency according to the TNI Standard;

2) withdrawn at the written request of the accredited laboratory; or

3) the accreditation expires.

f) An accredited laboratory may make a written request to add to its scope of accreditation. The Agency will conduct an on-site assessment if the additional fields of testing or test methods require the use of a chemical process, an analytical process, instrument or piece of equipment that the laboratory has not been previously accredited to use.

g) Laboratories shall post or display their most recent certificate of accreditation and scope of accreditation in a prominent place in the laboratory facility.

h) A laboratory shall notify the Agency in writing within 30 days after a change of any matter that may affect the ability of the laboratory to fulfill the requirements for accreditation, including, but not limited to, any change in the following:

1) its legal, commercial, ownership or organizational status;

2) the organization, top management and key personnel, including, but not limited to, laboratory director, quality assurance officer, supervisor, analyst;

3) main policies, including, but not limited to, its quality system;

4) resources and premises, including, but not limited to, a major remodeling of a laboratory or relocation of the physical facility.

i) Transfer of Accreditation

1) Accreditation shall be transferrable when the following conditions are in effect:

A) the transferring owner agrees in writing with the transferee, before the transfer of ownership takes place, to be accountable and liable for any analyses, data and reports generated up to the time of legal transfer of ownership; and

B) the transferee agrees in writing with the transferring owner to be accountable and liable for any analyses, data and reports generated after the legal transfer of ownership occurs.

2) The laboratory shall submit a copy of the agreement entered under subsection (i)(1) to the Agency prior to transfer of ownership.

3) Transfer of accreditation pursuant to this subsection (i) will not alter the laboratory's accreditation status or scope of accreditation.

4) If ownership is transferred, the transferee will not be responsible for payment of fees to the Agency during the remainder of the yearly period, provided that the transferring owner has fully paid the required fees to the Agency pursuant to 35 Ill. Adm. Code 185.

Ill. Admin. Code tit. 35, § 186.125

Repealed at 26 Ill. Reg. 12167, effective July 29, 2002

Adopted at 38 Ill. Reg. 18627, effective 9/1/2014