Laboratory - Documentation Checklist
17025 General Accreditation Requirements
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.
Laboratory Documentation Submittal Requirements
Initial / Full
Assessment
Type I
Surveillance
Type II
Surveillance
X
X
X
X
If
Changed
If
Changed
X
X
X
X
X
X
X
X
X
X
X
X
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.
CMC changes typically do not require a new estimate.
If the scope remains the same and is listed correctly on our website put
SAME.
L-A-B Form 48B - Assessment Checklist



Complete on its latest revision level.
Completely filled out Electronically.
Required for surveillance if changed
L-A-B Form 001 – Traceability Tracking (Per L-A-B Policy 001)

Assure form is updated and current.
Laboratory Quality Manual
Lab Policies, Procedures, Scope Related Technical Procedures

Examples include (but not limited to) – Policy for ethics, procedures for
document control, technical procedures or work instructions supporting the
scope, etc.
X
Supporting Uncertainty Budgets for the Scope (Calibration Only)


Provide estimation of uncertainty to support all the CMC(s) (for calibration
parameters) in accordance with L-A-B Policy 001.
This is required to be reviewed every year and submitted to L-A-B. Critical
for calibration parameters.
Latest Management Review and Internal Audit Results

Provide the most current Management Review and Internal Audit results
completed to the requirements of ISO / IEC 17025.
Form 18 – 17025 - Laboratory Documentation Checklist - Rev 22 – 02/11/15
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Laboratory - Documentation Checklist
17025 General Accreditation Requirements
Laboratory Organizational Chart
Proof of Purchase of ISO/IEC 17025:2005

Initial assessment only.
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Initial
Only
Laboratory Calibration Certificate or Test Report

Provide a copy of a typical example(s) of your Laboratory Calibration
Certificate or Test Report in accordance with 5.10 of ISO/IEC17025 and
L-A-B Policy 001.
Form 002 – PT / ILC / IQA Tracking (Per L-A-B Policy 002)

Assure form is updated and current.
PT / ILC / IQA - 4 Year Plan (Per L-A-B Policy 002)


Form 28.12 - ILC/PT/ IQA Tracking or equivalent plan.
Updated.
PT / ILC / IQA - Results


Provide most recent PT / ILC / IQA results covering the last 365 days.
As identified on the PT / ILC / IQA 4 Year Plan.
Form 18 – 17025 - Laboratory Documentation Checklist - Rev 22 – 02/11/15
Page 2 of 2