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					Reference Appendix B Appendix E 3.3.4, k 5.9 4.15

3.5.1 Appendix D

Description Guidance Request for Recognition, Include entire scope of laboratory services Parameters and Scope, annually. Must be complete for entire scope, Uncertainty Charts reviewed annually, updated as needed, and Include evidence of corrective action or Proficiency Testing plan when appropriate. Alternative formats Follow-up Forms are acceptable provided they are integrated Previously identified nonconformities or Review previous feedback for assurance of requests. compliance. Submit necessary evidence. Used to update laboratory directory and Laboratory Contacts contacts database. Review each year.

Submission Lab: ______________________________ Yes: all laboratories annually. FOR ALL LABS. Yes: when changes occur. Yes: all laboratories annually. FOR ALL LABS. Please submit Excel files used in the lab. Yes: for expanding Scope.
FOR ALL LABS.

Yes: all laboratories annually, for each completed PT.

Yes: all laboratories annually. Can integrate lab contacts with Appendix B. Yes: when changes occur. Yes: when requested.

Appendix C

Internal Assessment of Management System

Yes: if laboratory does not have The 17025 checklist is preferred. Be sure to sign/date, current or full Recogntion. Complete as a form with cross-references and add laboratory name. This is a FORM, not a checklist. Yes: for renewals. and details. Yes: when requested. Yes: if laboratory does not have Examples: PT/ILC checklist, software checklist, section 5.2 current or full Recogntion. checklist, facility environment checklist, section 6.x checklist. Yes: for renewals. Yes: when requested.

4.14.1

Internal Technical Assessment

Appendix C does not provide a complete technical audit. Contact WMD for guidance if system is not already in place.

4.15

Management Review

4.2 4.14

Laboratory Quality Manual and Associated Appendices

Yes: if laboratory does not have Follow Handbook 143, Section 4.15. FOR ALL LABS THIS YEAR. current or full Recogntion. Provide a signed report that includes a Yes: for renewals. laboratory management review. Yes: when requested. Must include complete set of laboratorydeveloped reference documents. New or Yes: if laboratory does not have major revisions must include the internal current or full Recogntion. laboratory assessment of the manual and Yes: when changes occur. its references. Yes: when requested. Must include complete set of laboratory- Yes: if laboratory does not have developed reference documents. New or current or full Recogntion. major revisions must include the internal Yes: when changes occur. laboratory assessment of the manual and Yes: when requested. its references.

4.2 4.14

Laboratory Administrative Procedures

Reference 5.2 Appendix B Table 2

5.4

5.6

Description Guidance Submission Request for Recognition, Include entire scope of laboratory services Laboratory Auditing Parameters and Scope, Program (LAP) problems Required asannually. in Table 2. specified Yes: when complete. Submit copies of laboratory-developed Yes: when new procedures are Laboratory-Developed calibration procedures (and significant developed. Calibration Procedures modifications of published procedures) Yes: when requested. Only needed for calibrations of standards obtained during the year from other Yes: submit new reports during Calibration Reports laboratories. annual review cycle. Yes: if laboratory does not have current or full Recogntion. Yes: when requested.

Lab: ______________________________

5.9

Measurement Assurance Must be in place for all measurement & Control Charts services; see section 5.9 in this Handbook.

5.2

Other Special Technical Requests Examples of Special Technical Requests: Training Records, Training Plan, Succession Planning

May be used for national assessments and Yes: if laboratory does not have summaries as needed. Will reference current or full Recogntion. Handbook criteria. Yes: when requested.

5.3

Assessment of Laboratory Environmental Conditions Summary of Laboratory Equipment and Suitability Traceability Hierarchy Assessments Samples of Calibration Reports
FOR ALL LABS. SAP 10 (or equivalent); Laboratory Computer Systems Assessment; Software Assessment Inventory; Technical Assessment of Software Rev1 for each Spreadsheet.

5.5 5.6 5.1

Multiple sections

Computer Systems Assessment

Guidance will be provided when requests are made.

Yes: when requested.


				
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