Free checklist

Every document you need for ISO 9001 certification -- personalized by audit stage and organization size

  • Select certification stage (initial, surveillance, recertification) and organization size
  • Check off documents as you prepare them -- progress saves automatically
  • Copy the report, share the link, or print it for your audit preparation files

Proof: Covers 7 ISO 9001:2015 clause areas, ~40 documents, and 3 organization size profiles

Get a personalized list of every document needed for ISO 9001:2015 certification -- based on your certification stage and organization size.

  • Covers context analysis, quality policy, risk registers, competence records, supplier evaluations, internal audits, corrective actions, and management review records.
  • Adapts to certification stage: initial certification requires full documentation, surveillance audits focus on key areas, and recertification covers the complete scope.
  • Differentiates by organization size: small (1-50), medium (50-250), and large (250+) with additional requirements for larger organizations.

Free, no signup, and your progress saves automatically in your browser.

ISO 9001 certification requires documented evidence across organizational context, leadership, planning, support, operations, performance evaluation, and improvement. Missing documentation is the number one reason audits result in nonconformities. This tool builds a complete checklist tailored to your organization so nothing falls through the cracks.

Free, no signup, and progress saves in your browser until you need it.

Audit checklist

Select your certification stage and organization size below. Check off documents as you prepare them.

Disclaimer: This checklist is for informational purposes only and does not constitute professional certification or auditing advice. ISO 9001 requirements are interpreted differently by certification bodies and auditors. Consult a qualified ISO consultant or your certification body for guidance specific to your organization.

Last updated: January 2026

Showing 33 documents for Initial Certification at Small (1-50 employees) organization

0 of 33 documents complete

Interested parties analysisRequiredClause 4.2
Scope of QMS statementRequiredClause 4.3
QMS process map / interaction diagramRequiredClause 4.4
SWOT analysis or equivalentRecommendedClause 4.1
Quality policyRequiredClause 5.2
Quality objectives (measurable, per function)RequiredClause 5.1.1
Management review recordsRequiredClause 5.6
Organizational roles, responsibilities, and authoritiesRequiredClause 5.3
Customer focus evidenceRequiredClause 5.1.2
Risk and opportunity registerRequiredClause 6.1
Risk treatment plansRequiredClause 6.1
Quality objectives action plansRequiredClause 6.2
Competence records (training, education, experience)RequiredClause 7.2
Training plan and recordsRequiredClause 7.2
Calibration records for monitoring and measurement equipmentRequiredClause 7.1.5
Document control procedureRequiredClause 7.5
Documented information retention scheduleRequiredClause 7.5.3
Operational planning recordsRequiredClause 8.1
Customer requirements review recordsRequiredClause 8.2
Design and development records (if applicable)RecommendedClause 8.3
Supplier evaluation and re-evaluation recordsRequiredClause 8.4
Production/service provision control recordsRequiredClause 8.5
Nonconforming output recordsRequiredClause 8.7
Release and delivery recordsRequiredClause 8.6
Customer satisfaction data and analysisRequiredClause 9.1.2
Internal audit program and reportsRequiredClause 9.2
Management review minutesRequiredClause 9.3
Process performance metrics and KPIsRequiredClause 9.1.1
Monitoring and measurement resultsRequiredClause 9.1.1
Corrective action recordsRequiredClause 10.2
Root cause analysis documentationRequiredClause 10.2
Continual improvement evidenceRequiredClause 10.3
Nonconformity and corrective action logRequiredClause 10.2

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Why ISO 9001 documentation matters

ISO 9001 is not just about having a quality manual. Auditors expect documented evidence of a functioning quality management system across your entire organization.

01

Pass certification

Certification bodies audit against specific documented information requirements. A single missing document can result in a major nonconformity, delaying certification by months. This checklist ensures you have every document auditors expect to see.

02

Reduce audit stress

The weeks before an audit are often chaotic. Having a tracked checklist means your quality manager knows exactly what is ready and what still needs work -- no last-minute scrambling to find documents or create records that should have existed for months.

03

Continuous improvement

ISO 9001 is a living system, not a one-time project. Proper documentation creates the feedback loops that drive continual improvement -- from corrective action tracking to management review outputs to lessons learned. The documentation is the improvement engine.

Preparing for an ISO 9001 audit? Auto-organize your QMS documents as they come in.

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Frequently asked questions

What documents are required for ISO 9001 certification?

ISO 9001:2015 requires documented information including a quality policy, quality objectives, scope of the QMS, records of competence, operational planning records, monitoring and measurement results, internal audit reports, management review records, and corrective action records. The exact set depends on your organization size and the processes you operate.

Does this checklist adapt to different certification stages?

Yes. The checklist adjusts based on whether you are preparing for an initial certification, a surveillance audit, or a full recertification. Surveillance audits focus on a subset of clauses, while initial certification and recertification require evidence across all ISO 9001 clauses.

Can I save my progress?

Yes. Your progress saves automatically in your browser using local storage. You can close the tab, come back days later, and pick up exactly where you left off. No account or signup required. Progress is saved separately for each certification stage and organization size combination.

How often should ISO 9001 documents be reviewed?

Most ISO 9001 documents should be reviewed at least annually as part of your management review process. However, some documents like the risk register, quality objectives, and corrective action log should be living documents updated whenever relevant changes occur. Internal audits should follow a planned schedule that covers all QMS processes within each certification cycle.

Does this checklist replace a qualified auditor?

No. This checklist is a free reference tool to help you identify and track the documents typically required for ISO 9001:2015 compliance. It does not replace a qualified auditor or consultant. Every organization should work with an accredited certification body and consider engaging an experienced QMS consultant to ensure all requirements are met.