Document Control Audit Checklist - FREE PDF
Audit document control system per ISO 9001:2015 documented information requirements.
- Industry: Manufacturing / All Industries
- Frequency: Annual / Quarterly
- Estimated Time: 2-4 hours
- Role: Document Controller / Quality
- Total Items: 32
- Compliance: ISO 9001:2015 Clause 7.5, 21 CFR 820
Pre-Audit/Pre-Task Verification
Verify conditions before proceeding.
- Scope/area defined?
- Required documentation available?
- Required personnel available?
Process/System Evaluation
Evaluate processes per ISO 9001:2015 Clause 7.5 requirements.
- Procedures followed correctly?
- Equipment functioning properly?
- Controls effective?
- Records accurate and complete?
Compliance Verification
Verify compliance with ISO 9001:2015 Clause 7.5, 21 CFR 820.
- Standards requirements met?
- Objectives achieved?
- Improvement opportunities identified?
Findings and Actions
Document findings and required actions.
- Overall Result
- Findings Description
- Corrective/Preventive Actions
- Signature
Pre-Shift Verification & Setup
Initial verification before operations begin
- Operator / Inspector Name
- Date
- Shift Number
- Production Line / Area
- Previous shift handover notes reviewed?
Safety Protocols & Compliance
Verify all safety measures are in place per OSHA standards
- LOTO procedures verified for all equipment?
- All machine guards in place and secured?
- Emergency stop buttons tested and functional?
- Required PPE worn by all operators?
- Safety signage visible and current?
Equipment & Operational Readiness
Verify equipment is calibrated and operational
- Equipment calibration current and documented?
- All gauges and instruments reading correctly?
- Lubrication schedule maintained?
- Any abnormal sounds, vibrations, or leaks?
Quality Control Standards
Verify product quality meets specifications
- Current specifications/work instructions available?
- First article inspection completed?
- Measurement tools calibrated and in tolerance?
- Reject/scrap rate within acceptable limits?
Related Manufacturing Checklists
- Manufacturing Quality Control Inspection
- Shift Start Production Readiness Checklist
- End of Shift Shutdown & Handover Checklist - FREE PDF
- In-Process Quality Check Checklist
- Daily Preventive Maintenance Walkthrough
- Packaging Line Compliance Checklist