Wisconsin Administrative Code
Department of Natural Resources
NR 100-199 - Environmental Protection General
Chapter NR 149 - Laboratory Accreditation
Subchapter IV - Accreditation Process
Section NR 149.14 - Application for accreditation

Universal Citation: WI Admin Code ยง NR 149.14

Current through August 26, 2024

(1) GENERAL REQUIREMENTS.

(a) Laboratories are required to do all the following:
1. Submit applications to seek, revise, or transfer accreditations.

2. Declare the fields of accreditation being sought, revised, or transferred in corresponding applications.

3. For drinking water, declare the methods of analysis for ana-lytes and analyte groups in the fields of accreditation being sought, revised, or transferred.

4. Submit a current analytical instrument list.

5. Submit acceptable results for PT samples when the department requires the PT sample analysis.

6. For laboratories that are not physically located in Wisconsin, submit a statement of intent to perform analyses for regulatory samples originating in Wisconsin. Intent to perform analyses for regulatory samples originating in Wisconsin can be manifested by any of the following:
a. Referencing the affiliation of the applicant laboratory with a plant, office, laboratory, or engineering firm physically located in the state of Wisconsin.

b. Submitting a letter from a potential client requesting the applicant to perform analyses to determine compliance with a covered program.

7. Submit any information identified in an application or upon request of the department such as standard operating procedures or analytical data.

8. When the department determines that an evaluation is necessary to determine potential or actual compliance with this chapter, allow the department to perform an on-site evaluation.

9. Remit any necessary fees required under this chapter.

Note: Fee information is contained in s. NR 149.21 Tables 1, 2, and 3.

10. Agree to comply with this chapter by signing the application.

(b) The department may not accept applications from a laboratory to which any of the following apply:
1. The laboratory has been issued a notice of violation for nonconformance with this chapter if the nonconformance has not been corrected and the notice of violation has not been closed.

2. The laboratory has been issued an administrative order of suspension or revocation for a violation of this chapter when the violation has not been closed and the suspension or revocation period specified in an order has not expired.

3. The laboratory was not in compliance with this chapter at the time the laboratory voluntarily relinquished its accreditations, nonconformances existing prior to relinquishing the accreditations have not been corrected, and at least 6 months have not elapsed since the voluntary action was undertaken.

(c) The department shall expire any application from a laboratory that has not submitted all the information and materials required as part of the application, or subsequent audit process, within a year of the receipt of the application form.

(d) The department may require the submittal of additional information necessary, such as standard operating procedures or analytical data, to determine a laboratory's actual or potential compliance with the provisions of this chapter.

(2) INITIAL APPLICATIONS.

(a) A laboratory seeking direct accreditation by the department that has never been accredited under this chapter, that has let its entire accreditation lapse for more than one year, or that has voluntarily relinquished all its accreditations shall submit an initial application to become accredited.

(b) A laboratory seeking reinstatement of its accreditations, following a suspension or revocation, shall submit an initial application for the desired accreditations.

(3) REVISED APPLICATIONS.

(a) A laboratory holding valid accreditations shall submit a revised application to seek additional accreditations in any of the following:
1. Matrices.

2. Technologies for an accredited matrix.

3. Analytes or analyte groups within an accredited analytical technology.

4. Analyte-method or analyte group-method combinations for the drinking water matrix.

(b) A laboratory seeking reinstatement of accreditations within a year after failing to renew those accreditations shall submit a revised application for the desired accreditations.

(c) A laboratory seeking to convert a valid certification into a registration or a registration into a certification shall submit a revised application.

(4) APPLICATIONS FOR ACCREDITATIONS THROUGH RECIPROCAL AGREEMENT ACCEPTANCE.

(a) A laboratory holding valid accreditations, licenses, or approvals from government bodies or private organizations, with which the department has established a reciprocal agreement, may have its accreditations, licenses, or approvals considered for acceptance by the department by submitting a reciprocity application.

(b) A laboratory applying for acceptance under an existing reciprocal agreement shall do all the following:
1. Submit certificates or official documents of the laboratory's accreditations, licenses, or approvals with its application.

2. Agree to notify the department of any changes, within 30 days of a change in its accreditation, licensure, or approval status with the entity with which the department has the agreement.

3. Submit a copy of the report of the most recent on-site evaluation performed by the entity with which the department has the agreement.

(5) ISSUANCE OF ACCREDITATIONS.

(a) The department shall issue accreditations to laboratories through certificates that meet the criteria specified in s. NR 149.06.

(b) The department shall issue a certificate to a laboratory submitting an initial, revised, or reciprocity application for accreditation within 30 days of the date by which the laboratory successfully completes an on-site evaluation or the date by which the department waives an on-site evaluation, subject to all the following:
1. The department may not schedule or waive an on-site evaluation of an applicant laboratory until all the requirements of sub. (1) have been completed.

2. A laboratory completes an on-site evaluation successfully when it addresses, to the department's satisfaction, any deficiencies encountered during the on-site evaluation.

(c) Following an on-site evaluation, the department may issue accreditations, on a case-by-case basis, that are unaffected by any deficiencies encountered during the on-site evaluation.

(d) The department shall issue a revised certificate of accreditation to an accredited laboratory within 30 days of the occurrence of any of the following:
1. Receiving notification from that laboratory that it is changing its name without changing ownership.

2. Approval of relocation to a new facility that does not compromise the laboratory's ability to meet the requirements of this chapter.

Disclaimer: These regulations may not be the most recent version. Wisconsin may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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