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NVLAP LAB CODE: …

Tags: accreditation decision, assessment report, decision questions, failure, guidance, laboratory accreditation program, laboratory name, national institute of standards, national institute of standards and technology, nvlap lab code, proficiency testing, signature sheet, technical experts, technology national, timeframe,
Pages: 17
Language: english
Created: Thu Oct 27 14:15:25 2005
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                                                     NVLAP LAB CODE:



                          National Institute of Standards and Technology
                   National Voluntary Laboratory Accreditation Program (NVLAP)

                                        SIGNATURE SHEET

Laboratory Name

Field(s) of Accreditation

Assessor Name(s) and Signature(s)



On-Site Assessment Dates

Type of Assessment (check one):           Initial         Renewal            Monitoring           Other

Note: Please list laboratory personnel present at the closing meeting on the back of this page.


                                     Instructions for the Laboratory

Respond in writing within 30 days of the date of this report, addressing all nonconformities documented by the
assessor(s). All nonconformities must be satisfactorily resolved before accreditation may be granted. See
page 2 for guidance and instructions on responding to nonconformities.

The On-Site Assessment Report, the information supplied by you, and the results of any required proficiency
testing will be reviewed by NVLAP with the assistance of technical experts as necessary. NVLAP is solely
responsible for the content of this report and reserves the right to change the findings of the assessor(s),
based on the results of this review. The final evaluation of your laboratory, for the purpose of deciding whether
to approve or deny an initial or a renewal accreditation, will be conducted by NVLAP. It is the responsibility of
the Authorized Representative to understand and respond with sufficient information within the required
timeframe. Failure to respond may result in the suspension of your laboratory's accreditation or, in the case of
a new laboratory, may delay an accreditation decision. Questions concerning this response should be
directed to NVLAP.

Send your response to:      NVLAP
                            National Institute of Standards and Technology
                            100 Bureau Drive, Stop 2140
                            Gaithersburg, MD 20899-2140



                                             Signed Statement

The assessor has discussed the contents of this report with members of the laboratory management who
agree to respond in writing to NVLAP, regarding resolution or correction of any nonconformities noted, within
30 days of the date of this report.


__________________________________________                     _____________________________________
Signature of Authorized Representative or designee                           Printed Name


NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                                                 PAGE 1 OF 17
                                                      NVLAP LAB CODE:



                       Guidance and Instructions on Laboratory Responses


Resolving nonconformities: A laboratory's response shall include documentation that the specified
nonconformities have been corrected and/or a plan of corrective actions. A corrective action plan must include
a list of actions, target completion dates, and names of persons responsible for discharging those actions. All
nonconformities must be satisfactorily resolved before accreditation may be granted. For accredited
laboratories, this is interpreted to mean that nonconformities adversely affecting the outcome of calibrations or
tests must be addressed and corrected immediately (within the 30 days). Evidence must be supplied which
clearly demonstrates that actions taken fully resolve the nonconformities, thereby removing any concern as to
the quality of results of the calibrations or tests conducted by the laboratory. In those cases where specified
nonconformities do not directly affect the results of calibrations or tests, such as those related to record-
keeping, NVLAP may accept a plan and a schedule, as previously described, as satisfactory resolution. When
this occurs, laboratories are expected to submit sufficient objective evidence demonstrating that the
nonconformities have, in fact, been resolved according to the schedule. All responses must be sent directly to
the NVLAP office, not to the assessor(s).

Referencing nonconformities: Each nonconformity must be referenced in your response by item number as
it is listed in the appropriate checklist. Cite the requirement against which the nonconformity is stated and,
where more than one nonconformity was recorded against the same requirement, either restate the specific
nonconformity, or indicate to which test/parameter the response is related.

Objective evidence: The laboratory may ask for clarification of a nonconformity either during the closing
meeting or from the appropriate NVLAP Program Manager. It is required that objective evidence be submitted
as proof that a nonconformity has been effectively resolved. Such evidence includes updated procedures,
uncertainty analyses (where appropriate), corrected/updated sections of the quality documents associated with
a stated nonconformity, copies of completed records, corrective action reports, etc. NVLAP reviews all
responses, with the assistance of appropriate technical experts as necessary, and is solely responsible for the
final decision regarding the resolution of a nonconformity and for the granting of initial or renewal accreditation.




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                                                   PAGE 2 OF 17
                                                NVLAP LAB CODE:



                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

          CHANGES TO CURRENT OR REQUESTED SCOPE OF ACCREDITATION
                        (Additions, Deletions, Modifications)




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                 PAGE 3 OF 17
                                                NVLAP LAB CODE:



                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

                                        4.1 ORGANIZATION




                                   4.2 MANAGEMENT SYSTEM




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                 PAGE 4 OF 17
                                                NVLAP LAB CODE:



                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

                                    4.3 DOCUMENT CONTROL




                  4.4 REVIEW OF REQUESTS, TENDERS AND CONTRACTS




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                 PAGE 5 OF 17
                                                NVLAP LAB CODE:



                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

                   4.5 SUBCONTRACTING OF TESTS AND CALIBRATIONS




                         4.6 PURCHASING SERVICES AND SUPPLIES




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                 PAGE 6 OF 17
                                                NVLAP LAB CODE:



                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

                                4.7 SERVICE TO THE CUSTOMER




                                         4.8 COMPLAINTS




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                 PAGE 7 OF 17
                                                NVLAP LAB CODE:



                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

       4.9 CONTROL OF NONCONFORMING TESTING AND/OR CALIBRATION WORK




                                       4.10 IMPROVEMENT




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                 PAGE 8 OF 17
                                                NVLAP LAB CODE:



                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

                                    4.11 CORRECTIVE ACTION




                                    4.12 PREVENTIVE ACTION




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                 PAGE 9 OF 17
                                                NVLAP LAB CODE:



                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

                                  4.13 CONTROL OF RECORDS




                                      4.14 INTERNAL AUDITS




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                 PAGE 10 OF 17
                                                NVLAP LAB CODE:



                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

                                  4.15 MANAGEMENT REVIEWS




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                 PAGE 11 OF 17
                                                NVLAP LAB CODE:



                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

                                           5.1 GENERAL




                                          5.2 PERSONNEL




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                 PAGE 12 OF 17
                                                NVLAP LAB CODE:



                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

                5.3 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS




            5.4 TEST AND CALIBRATION METHODS AND METHOD VALIDATION




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                 PAGE 13 OF 17
                                                NVLAP LAB CODE:




                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

                                          5.5 EQUIPMENT




                               5.6 MEASUREMENT TRACEABILITY




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                 PAGE 14 OF 17
                                                NVLAP LAB CODE:



                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

                                           5.7 SAMPLING




                      5.8 HANDLING OF TEST AND CALIBRATION ITEMS




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                  PAGE 15 OF 17
                                                NVLAP LAB CODE:



                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

            5.9 ASSURING THE QUALITY OF TEST AND CALIBRATION RESULTS




                                 5.10 REPORTING THE RESULTS




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                  PAGE 16 OF 17
                                                NVLAP LAB CODE:



                     ON-SITE ASSESSMENT NARRATIVE SUMMARY

                      ANNEX A. REFERENCING NVLAP ACCREDITATION




    ANNEX B. IMPLEMENTATION OF TRACEABILITY POLICY IN ACCREDITED LABORATORIES




NVLAP ON-SITE ASSESSMENT REPORT (REV. 2005-10-27)                    PAGE 17 OF 17