Codex HomeGlossaryCompareStarter PacksChecklistsClicarity.comLogin
ISO 9001

ISO 9001 Audit Readiness Checklist

Use this checklist to assess your readiness before a CB audit or surveillance visit. Items marked Critical will result in suspension if not in place. Items marked Major will result in a major nonconformance.

37 items ✎ Click to tick 📷 Print / Save PDF
0 / 37 complete (0%)
Context & Leadership0/0
Quality policy documented, approved by top management, and communicated to all staffEmployees should be able to describe the quality policy in their own words.
CRITICAL
Scope of the QMS defined in writing — what is included and excludedMust state what products and services are in scope and why any requirements are excluded.
CRITICAL
Interested parties identified — customers, regulators, employees, suppliersTheir relevant needs and expectations documented.
STANDARD
Management representative assigned with defined responsibilities
MAJOR
Quality objectives defined — specific, measurable, with owners and timelinesNot vague intentions — real numbers and deadlines.
MAJOR
Process Documentation0/0
Process map or list showing all key business processesHow inputs become outputs. Sequence and interaction of processes.
MAJOR
Documented procedures (SOPs) for all processes that affect product or service quality
CRITICAL
SOPs are current, approved, version-controlled, and accessible at point of useOutdated SOPs are a common major nonconformance.
CRITICAL
Work instructions for critical tasks (where absence of instructions would affect quality)
STANDARD
Document control procedure — how documents are created, approved, updated, and retired
MAJOR
Customer & Sales0/0
Customer requirements formally captured before acceptance of orders
MAJOR
Customer satisfaction measured — survey, complaint rate, repeat order rate
MAJOR
Customer complaint procedure with root cause analysis and CAPA
MAJOR
Customer complaints responded to within defined timeframe
STANDARD
Communication process with customers for queries, changes, and feedback
STANDARD
Supplier & Purchasing0/0
Approved supplier list maintained and reviewed periodically
MAJOR
Supplier evaluation criteria defined (quality performance, delivery, compliance)
MAJOR
Purchase orders specify product/service requirements clearly
STANDARD
Incoming material / service verification procedure in place
MAJOR
Supplier nonconformance records maintained with CAPA
STANDARD
Operations & Production0/0
Production / service delivery procedures documented and followed
CRITICAL
Stage-wise monitoring and measurement of products/servicesRecords showing what was checked, when, by whom.
CRITICAL
Nonconforming output procedure — identification, quarantine, disposition
MAJOR
Traceability of product through production stages
STANDARD
Equipment maintenance schedule maintained
STANDARD
Measuring equipment calibrated with current certificatesExpired calibration = immediate major finding.
CRITICAL
Competence & Training0/0
Skill matrix / competence records for all quality-affecting rolesRole requirements defined and current levels assessed.
CRITICAL
Training conducted and records maintained for all staff
MAJOR
Post-training assessment confirming competence improvementTraining attendance alone is not competence.
MAJOR
Induction training records for all new staff
STANDARD
Internal Audit & Review0/0
Annual internal audit programme documented and followedAll QMS areas audited within the year.
CRITICAL
Trained internal auditors — independent of areas they audit
CRITICAL
Audit reports issued for every audit with findings documented
CRITICAL
CAPA raised for every nonconformance with root cause and due date
MAJOR
CAPA effectiveness verified by auditor after implementation
MAJOR
Management review conducted with documented outputsAttended by top management — not delegated.
CRITICAL
Management review covers: audit results, customer feedback, KPIs, risk, resource needs
MAJOR
How to use this checklist: Tick each item you currently have in place. Items marked CRITICAL are highest-priority audit findings. Items marked MAJOR will result in a major nonconformance if absent. Use the Print button to save a PDF for your records or to share with your quality team.

This checklist is a readiness guide — not a substitute for a formal gap assessment. Engage a NABCB-accredited CB for a pre-assessment before your formal certification audit. Read the full ISO 9001 guide ↗
Last verified March 2026