[Code of Federal Regulations]
[Title 15, Volume 1]
[Revised as of January 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 15CFR285.7]

[Page 400-401]
 
                  TITLE 15--COMMERCE AND FOREIGN TRADE
 
 CHAPTER II--NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT 
                               OF COMMERCE
 
PART 285--NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM--Table of Contents
 
Sec. 285.7  Assessment.

    (a) Frequency and scheduling. Before initial accreditation, during 
the first renewal year, and every two years thereafter, an on-site 
assessment of each laboratory is conducted to determine compliance with 
the NVLAP criteria.
    (b) Assessors. NVLAP shall select qualified assessors to evaluate 
all information collected from an applicant laboratory pursuant to 
Sec. 285.6 of this part and to conduct the assessment on its behalf at 
the laboratory and any other sites where activities to be covered by the 
accreditation are performed.
    (c) Conduct of assessment. (1) Assessors use checklists provided by 
NVLAP so that each laboratory receives an assessment comparable to that 
received by others.
    (2) During the assessment, the assessor meets with management and 
laboratory personnel, examines the quality system, reviews staff 
information, examines equipment and facilities, observes demonstrations 
of testing or calibrations, and examines tests or calibration reports.
    (3) The assessor reviews laboratory records including resumes, job 
descriptions of key personnel, training, and competency evaluations for 
all staff

[[Page 401]]

members who routinely perform, or affect the quality of the testing or 
calibration for which accreditation is sought. The assessor need not be 
given information which violates individual privacy, such as salary, 
medical information, or performance reviews outside the scope of the 
accreditation program. The staff information may be kept in the 
laboratory's official personnel folders or separate folders that contain 
only the information that the NVLAP assessor needs to review.
    (4) At the conclusion of the assessment, the assessor conducts an 
exit briefing to discuss observations and any deficiencies with the 
authorized representative who signed the NVLAP application and other 
responsible laboratory staff.
    (d) Assessment report. At the exit briefing, the assessor submits a 
written report on the compliance of the laboratory with the 
accreditation requirements, together with the completed checklists, 
where appropriate.
    (e) Deficiency notification and resolution. (1) Laboratories are 
informed of deficiencies during the on-site assessment, and deficiencies 
are documented in the assessment report (see paragraph (d) of this 
section).
    (2) A laboratory shall, within thirty days of the date of the 
assessment report, provide documentation that the specified deficiencies 
have either been corrected and/or a plan of corrective actions as 
described in the NVLAP handbooks.
    (3) If substantial deficiencies have been cited, NVLAP may require 
an additional on-site assessment, at additional cost to the laboratory, 
prior to granting accreditation. All deficiencies and resolutions will 
be subject to thorough review and evaluation prior to an accreditation 
decision.
    (4) After the assessor submits their final report, NVLAP reviews the 
report and the laboratory's response to determine if the laboratory has 
met all of the on-site assessment requirements.