BECOME AN INDEPENDENT LABORATORY IN THE AOAC RESEARCH INSTITUTE PROGRAM
APPLICATION FOR LABORATORIES INTERESTED IN BECOMING AOAC RI INDEPENDENT LABORATORIES
LABORATORY CONTACT INFORMATION
Name of Applicant Laboratory
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Street Address
City or Town (Mailing address)
State or Province (Mailing Address)
Country
*
Postal Code
Telephone Number
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Name of Primary Contact or Representative
*
Title of Primary Contact or Representative
E-mail of Primary Contact
*
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Which field would you like to focus on?
Chemistry
Microbiology
Both
See the Training Course Policies below. Print for your records
SCOPE OF LABORATORY
Has the laboratory participated in analytical method evaluation/validation studies?
YES
NO
NOT SURE
If yes, for which organizations?
Is the laboratory accredited?
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YES
NO
NOT SURE
If the laboratory is accredited, through which organization is accreditation achieved?
Does the laboratory participate in any proficiency testing programs?
YES
NO
NOT SURE
If yes, which programs?
Please state the scope of methods for which your laboratory would participate in AOAC RI method evaluations?
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Please provide "reference" methods used .
Please list type of studies you consider your Expertise:
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Please attach a copy of the laboratory"s accredited scope. (Multiple files may be attached. File size limit is 20 MB.)
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Please list the various major types of technology the laboratory uses to fulfill its scope.
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LABORATORY PERSONNEL
Name of Laboratory Representative Authorized to Complete this Form
*
Title of the Representative
*
Telephone Number of Representative
*
E-mail of Representative
*
Name of Laboratory Quality Manager/Director
Title
Telephone Number
E-mail
Please submit the names of two laboratory analysts who will be assigned to work on AOAC method studies.
Laboratory Analyst #1
*
Laboratory Analyst #2
*
Please attach the resumes of the laboratory personnel named in this section.
*
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FINANCIAL PERSONNEL
Name of Accounting Manager/Director
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Telephone Number
E-mail Address
*
Name and title of representative(s) handling AOAC account(s)
*
Telephone Number
E-mail Address
*
Primary Payment Term
45 days
60 days
90 days
Other
Secondary Payment Term
45 days
60 days
90 days
Other
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TERMS AND CONDITIONS
General Criteria for Independent Laboratories Organization and Management - The laboratory shall be legally identifiable and shall have the following attributes: • Managerial staff with the authority and resources to accomplish the task; • Adequate facilities, equipment, and staff to complete the work in a quality and timely manner; • Demonstrated experience or capability using the technology necessary for testing of the test kit under evaluation; • A technical manager who has overall responsibility for the technical operations. Whenever possible, the method evaluation will be supervised by a person familiar with the required test methods and procedures and the objectives of the assessment; • Documented policies and procedures to ensure the protection of clients" confidential information and proprietary rights; • Where appropriate, participation in inter-laboratory comparisons and proficiency testing pro-grams; • A quality control manager (however named) who has responsibility for the quality control system; • Compliance with Good Laboratory Practices (GLP) of the USFDA, USEPA, or other government mandated practices, if applicable. Quality Control System - The laboratory shall have an established quality control system appropriate for the range of testing activities it undertakes. The quality control system shall be documented and operational in day-to-day operations. A quality control manual shall be maintained under the direction of the quality control manager. The manual shall contain the following elements: • A quality control policy statement; • Organization and management structure of the laboratory; • Relations between management, technical operations, support services, and quality control system; • Job descriptions of the staff; • Arrangements for ensuring laboratory review of all new proposals to ensure the laboratory has the appropriate resources before commencing work; • Procedures for handling calibrations; • References to procedures for calibration, verification, and maintenance of equipment, and documentation of same; • References to verification practices including inter-laboratory comparisons, proficiency testing, use of reference materials, and internal quality control schemes; • Procedures for audit and review; and • Procedures for taking corrective action. Personnel - The independent laboratory shall have sufficient personnel having the necessary education, training, technical knowledge, and experience to conduct the testing protocol. Records on the relevant qualifications, training, skills, and experience of the technical personnel shall be maintained by the laboratory. Facilities - The laboratory shall have facilities suitable to conduct the testing protocol. The environment in which the testing activities are undertaken must not be such as to put into question or invalidate the results. The laboratory shall provide facilities for the monitoring, control, and recording of environmental conditions as appropriate. Equipment and Documentation - Equipment shall be properly maintained and maintenance records shall be documented. Records shall be maintained on each item of equipment and reference material significant to the calibrations or tests performed. Calibrations - The laboratory shall have an established program for the calibration of its measuring, test equipment, and analytical . I CERTIFY THAT THE LABORATORY NAMED AS APPLICANT MEETS ALL OF THE ABOVE CRIERIA.
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YES
NO
I CERTIFY THAT THE LABORATORY HAS A QUALITY SYSTEM AND USES GOOD LABORATORY PRACTICES.
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YES
NO
I CERTIFY THAT ALL RESPONSES IN THIS APPLICATION ARE ACCURATE TO MY KNOWLEDGE.
*
YES
NO
If you answered NO has been answered to any of the above, please disclose the change(s), modification(s) or revision(s).
I CERTIFY THAT I HAVE COMPLETE AUTHORITY TO SUBMIT THIS APPLICATION ON BEHALF OF THE LABORATORY
Today's Date
*
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Month
-
Day
Year
Date
Thank you for your cooperation.
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