Checklist

Quality System Audit Readiness Checklist (ISO / Customer)

Interactive checklist to confirm QMS documentation, traceability, control plans and CAPA readiness; captures findings, evidence, assigned actions, and status to prepare for customer or ISO audits.

Interactive Tool

Quality System Audit Readiness Checklist (ISO / Customer)

Use this interactive checklist to verify the most common Quality Management System elements before a customer or ISO audit. Run about 30 days before a scheduled audit to give time for corrective actions. For each checklist item, mark compliance, record evidence, capture any finding, and assign an action with an owner and due date.

Be concrete: evidence might be a document name, record ID, calibration tag number, or internal audit report reference. This form saves findings so teams can track closure and demonstrate readiness.

Assessment date

Enter the date of this readiness check (YYYY-MM-DD).

Site / Department

Where is this checklist being run?

Assessor (name)

Who is completing this checklist?

Document control – are SOPs and controlled documents current and accessible?

Includes revision control, approval records, and accessibility at point-of-use.

Evidence for document control

List document IDs, revision numbers, or location (e.g., Document: SOP-123 Rev 4).

Finding severity (document control)

Choose the severity of any gap discovered.

Action owner (document control)

Who will close this gap?

Action due date (document control)

Enter due date (YYYY-MM-DD).

Action status (document control)

Traceability – lot/serial identification and trace routes in place?

Can you trace product from lot/serial to raw materials and records?

Evidence for traceability

List example lot/serial numbers and record locations.

Finding severity (traceability)

Action owner (traceability)

Action due date (traceability)

Enter due date (YYYY-MM-DD).

Control plans – are control plans and work instructions in place and followed?

Evidence for control plans

Reference control plan IDs, process sheets, or example records.

Finding severity (control plans)

Action owner (control plans)

Action due date (control plans)

Calibration records – instruments calibrated and records available?

Include calibration due dates and sticker/tag references.

Calibration evidence

Finding severity (calibration)

Action owner (calibration)

Action due date (calibration)

CAPA – are corrective actions closed with evidence (or in progress with plan)?

Check closure evidence, root-cause analysis, and verification records.

CAPA evidence

List CAPA IDs or attach references.

Finding severity (CAPA)

Action owner (CAPA)

Action due date (CAPA)

Internal audits – are internal audit records and follow-ups available?

Internal audit evidence

Finding severity (internal audit)

Action owner (internal audit)

Action due date (internal audit)

Training matrix – training records up to date and traceable?

Verify records for personnel performing regulated tasks.

Training evidence

Finding severity (training)

Action owner (training)

Action due date (training)

Other findings (process, supplier, equipment, cleanliness, safety)

Capture any additional observations not covered above.

Overall readiness (1 = low, 5 = high)

Rate overall readiness for a customer or ISO audit. Lower scores indicate more work needed.

1.0 10.0

Recommendation

A quick recommendation to help scheduling decisions.

Go—ready for audit

Hold—address major gaps first

Defer—significant remediation required

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Quality System Audit Readiness Checklist (ISO / Customer)

Quality System Audit Readiness Checklist (ISO / Customer)

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