Home/Resources/ISO 9001 Checklist
✅ Free Checklist — 80 Points · ISO 9001:2015

ISO 9001:2015 Certification Preparation Checklist for Manufacturers

Know exactly where you stand before your auditor walks in. This 80-point checklist covers every requirement across all 10 clauses of ISO 9001:2015 — tailored for Indian manufacturing companies. Interactive and printable.

0 of 80 complete (0%)

📋 Clause 4 — Context of the Organization

Internal and external issues affecting the QMS are identified and documented
Include regulatory changes, customer expectations, technology shifts
Interested parties (customers, suppliers, regulators) and their requirements are listed
Maintain a documented register of stakeholders
Scope of the QMS is defined and documented — products/services, locations, exclusions
QMS processes are identified with inputs, outputs, sequence, and interactions defined
Process owners are assigned for each core QMS process
Risks and opportunities arising from context analysis are documented

🎯 Clause 5 — Leadership & Commitment

Top management demonstrates commitment — quality policy signed, QMS resources allocated
Look for management review minutes, signed policy, resource approvals
Quality Policy is documented, communicated, and understood at all levels
Quality Policy is reviewed for continuing suitability (at least annually)
Organizational roles, responsibilities, and authorities are defined and communicated
Org chart, job descriptions, QMS responsibility matrix
Customer focus — customer requirements and statutory/regulatory requirements are determined and met
Customer satisfaction is measured and monitored consistently

📐 Clause 6 — Planning

Risks and opportunities from Clause 4 analysis are addressed with documented plans
Quality objectives are measurable, monitored, and linked to the quality policy
Objectives must have target values, responsible owners, and timelines
Plans for achieving quality objectives are documented with who, what, when, and how to evaluate
Changes to the QMS are planned and controlled — documented change log maintained

🛠️ Clause 7 — Support & Resources

Adequate resources (people, infrastructure, environment) are determined and provided
All personnel affecting quality have documented competency requirements
Education, training, skill records per employee
Training records are current — gaps identified and addressed
Monitoring and measuring equipment is calibrated with records maintained Records
Calibration certificates, frequency schedule, traceability
Documented information (procedures, records) is controlled — access, retrieval, storage, retention
External documents (customer specs, regulatory requirements) are identified and controlled
Employees understand the quality policy and how their work affects quality outcomes
Awareness verified through training records or interviews

⚙️ Clause 8 — Operations

Operational planning and control: criteria for processes are defined, documented, and maintained
Customer communication process is established — enquiries, orders, complaints, changes
Requirements for products/services are determined and reviewed before commitment Critical
Order review process documented, customer PO review records
Design and development controls (if applicable) — plans, inputs, outputs, reviews, verification
Supplier/external provider evaluation criteria and approved vendor list maintained Records
Incoming inspection / incoming quality control process documented and followed
Production control: work instructions, SOP, in-process inspection records available at workstations
Product identification and traceability maintained throughout production Critical
Lot numbers, batch records, tags, traveller cards
Customer or external provider property is identified, protected, and any loss reported
Preservation of product quality during storage, handling, and delivery is maintained
Post-delivery activities are considered (warranty, installation support, statutory requirements)
Release of products/services — evidence that criteria are met before release Records
Nonconforming products are identified, controlled, and dispositioned — NCR records maintained

📊 Clause 9 — Performance Evaluation

What, when, and how to monitor/measure/analyze/evaluate is determined and documented
Customer satisfaction is measured — surveys, complaint data, on-time delivery data
Internal audit programme is established — schedule, criteria, auditor qualifications
Internal audit reports are documented and corrective actions tracked to closure
Management review is conducted at planned intervals with documented records Critical
Minutes must include inputs: audit results, KPIs, customer feedback, resource needs
Management review outputs include decisions on QMS changes, resource needs, improvement actions
Key quality KPIs are tracked: rejection rate, customer complaints, OTD, NCR closure rate

🔄 Clause 10 — Improvement

Nonconformities are analysed for root cause — documented corrective action process (8D or 5-Why)
Corrective actions are verified for effectiveness before closure
Lessons learned are applied to similar processes or products
Continual improvement opportunities are identified and actioned — CAPA log maintained

📁 Document Readiness Check

Quality Manual or equivalent QMS documentation is current and approved
All mandatory ISO 9001:2015 procedures are documented and implemented
Scope, quality policy, quality objectives, competency, calibration, NCR, internal audit, management review
Records retention policy is defined — minimum 3 years for quality records
All documents are version-controlled — current versions available, obsolete versions removed

📥 Download as PDF

Enter your email to unlock the printable PDF version + a blank scoring template for your pre-audit gap analysis.

  • 80-point interactive checklist
  • Blank scoring sheet for gap analysis
  • Common audit findings by clause
  • Document requirements quick-reference

No spam. Unsubscribe anytime.

🖨️ Print this checklist