Current through Register Vol. 48, No. 38, September 20, 2024
The application process consists of the submission of a written
application package, completion of an on-site assessment, and proficiency test
sample evaluations.
a) Application
Package
1) All laboratories seeking initial
accreditation or renewal accreditation shall annually submit a completed
application package. A complete application package includes an application on
forms prescribed by the Agency and payment of the appropriate fees required by
Section 17.8 of the Act and 35 Ill. Adm. Code 185.
2) The Agency shall send, no later than 60
days prior to the anniversary date of initial certification, an application
package to the accredited laboratories. Upon request, the Agency shall send an
application package to those laboratories seeking initial
accreditation.
3) If the Agency
receives an incomplete application package, the Agency will provide written
notice of the incomplete application, specifying the missing information. The
Agency review of the application package will not commence until the Agency
receives the missing information.
4) The following information shall be
included in the application:
A) laboratory
information, including laboratory name, address, telephone number, e-mail
address, fax number, hours of operation, laboratory owner, laboratory contact
person, name of the laboratory director, and name of the laboratory quality
assurance officer;
B) the type of
laboratory, for example commercial, federal or public water system;
C) the fields of testing and test methods for
which the laboratory is requesting accreditation, pursuant to Section
186.180;
D) the laboratory's quality assurance plan,
if the laboratory is seeking initial primary accreditation;
E) a statement of laboratory personnel
qualifications;
F) the primary
accrediting body, if the laboratory is seeking secondary accreditation;
and
G) a copy of the laboratory's
primary accreditation certificate, if the laboratory is seeking secondary
accreditation.
5) The
laboratory director shall sign and date the application package and attest in
writing to the validity of the information contained within the entire
application package.
6) Information
required in the application package must be complete and accurate.
7) Falsification of any information in the
application package shall result in denial of the application.
b) Within 30 days after receipt of
the complete application package, the Agency will review the complete
application package. If the complete application package does not meet the TNI
Standard as set forth in Section
186.135, the Agency
may deny the application or request additional information. The Agency shall
review any additional information submitted by the laboratory within 30 days
after receipt.
c) Initial Primary
Accreditation Application. If the complete application package meets the TNI
Standard, the Agency will conduct an on-site assessment and the laboratory
shall complete the proficiency test sample evaluation process.
d) Renewal Primary Accreditation Application.
If the complete application package meets the TNI Standard, the Agency will
conduct an on-site assessment on a biennial basis.
e) Secondary Accreditation. If the complete
application package meets the TNI Standard, the Agency will issue secondary
accreditation.
f) Procedures for
the on-site assessment and the proficiency test sample evaluation process are
set forth in the TNI Standard.