Laboratory - Documentation Checklist
LABPR 403 – DoD ELAP
Laboratory Name
Date
Instructions:
 All documentation stated below indicated with an X are required to be sent to L-A-B at least 30 days prior
to the scheduled assessment.
 L-A-B does not maintain any laboratory quality documentation on file.
 Any delays in receiving the necessary documentation may result in a rescheduling of the assessment
per L-A-B Policy 004.
 Electronic documentation must be sent to operations@l-a-b.com or l-a-b.sharefile.com.
 L-A-B documents are available on our website at www.l-a-b.com.
Initial / Full
Assessment
Type I
Surveillance
Type II
Surveillance
X
X
X
X
If
Changed
If
Changed
X
If
Changed
If
Changed
X
X
X
X
X
X
Laboratory Quality Manual
X
X
X
Laboratory Organizational Chart
X
X
X
Laboratory Documentation Submittal Requirements
Date
Submitted
New or Modified “Proposed Scope of Accreditation”



Scope changes require a Form 19 Change Notice and an updated Word
version.
If the scope is new or modified a new estimate may be required.
If the scope remains the same and is listed correctly on our website put SAME.
L-A-B Form 403A.2 - Assessment Checklist - Module 2 – General
Requirements



Complete on its latest revision level.
Completely filled out Electronically.
Required for surveillance if changed.
L-A-B Forms 403A.3, 403A.4, 403A.5, 403.A.6, 403.A.7 - Assessment
Checklists
Module 2 – 7 Testing Requirements (as applicable)



Complete on its latest revision level.
Completely filled out Electronically.
Required for surveillance if changed.
L-A-B Form 001 - Traceability Tracking

Provide this form which details the traceability of the calibrated items in the lab.
L-A-B Form 002 – PT Provider Tracking

Complete and updated as necessary.
Laboratory Quality System Procedures

Examples include (but not limited to) – Policy for ethics, procedures for
document control, technical procedures or work instructions supporting the
scope, etc.
Form 403A.1 – Rev 2 – 05/05/14
X
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Laboratory - Documentation Checklist
LABPR 403 – DoD ELAP
Laboratory Documentation Submittal Requirements
Initial / Full
Assessment
Type I
Surveillance
Type II
Surveillance
X
If
Changed
If
Changed
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Date
Submitted
Laboratory Technical SOP’s

All technical procedures supporting testing identified on the scope including
Preps and Instrumentation.

Required for surveillance assessments if changed.
Latest Management Review, Internal Audit Results

Most current Management Review and Internal Audit results completed to the
requirements of DoD QSM V5.
LOD / LOQ Verifications

For each Matrix to be included on the Scope of Accreditation.
In-House LCS Control Charts and Limits
Complete Data Packages - 2 per site covering scope testing methods

See note below on data package requirements.
Proficiency Testing Results


Last three rounds covering ALL matrixes / analytes from scope testing.
Preferred to provide your current years PT results submitted as the data
package above.
(Initial Assessment Only) - Recent NELAC Assessment Reports

Please also provide non-compliance reports and a summary of laboratory
actions to resolve.
Initial
Only
(Initial Assessment Only) - Recent DoD Component Assessment Reports

Example: Army, Navy, Air Force, Army Corps, ect.

Please provide non-compliance reports and a summary of laboratory actions to
resolve.
Initial
Only
Note – A complete Data Package shall contain the following:
1. Calibration data (raw data printout or log sheets)
2. Preparation batch records (preparation)
3. Analytical batch records (instrumentation)
(The above is for samples and QC and associated controls (blanks, negatives, positives as applicable to the
technology)
4. Standards / Reagent Log Books Case narrative, final sample results, final qc results
5. Data review checklist or record(s)
Form 403A.1 – Rev 2 – 05/05/14
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