Perform an ISO 9001 2015 Audit using eAuditor
ISO 9001 2015 Audit is a systematic, independent, and documented process for evaluating whether an organization’s Quality Management System (QMS) complies with the ISO 9001 2015 standard. The audit examines how effectively the QMS is implemented and maintained, and how well it supports consistent delivery of products or services that meet customer and regulatory requirements.
Performing an ISO 9001 2015 Audit using eAuditor allows organizations to systematically assess the effectiveness, compliance, and continual improvement of their Quality Management System (QMS). With eAuditor, the audit process becomes fully digital, enabling real-time evaluations of quality processes, documentation of evidence, assignment of corrective actions, and generation of instant audit reports. This ensures audit consistency, traceability, and readiness for certification or surveillance audits.
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Preparation for ISO 9001 2015 Audit Using eAuditor
1.1 Define the Audit Scope and Type
- Audit Type:
- Internal Audit (first-party)
- Supplier Audit (second-party)
- Certification/Surveillance Audit (third-party)
- Scope:
- Entire organization or selected functions (e.g., procurement, production, customer service)
- Processes, departments, or geographical locations
1.2 Collect and Review Relevant Documents
- ISO 9001 2015 standard clauses
- Quality Manual and QMS documentation
- Quality policy and objectives
- Process maps and SOPs
- Previous audit reports and corrective actions
- Risk and opportunity registers
- Customer feedback and complaint records
1.3 Build or Customize eAuditor Checklist
Develop a digital checklist in eAuditor that mirrors the ISO 9001 2015 clauses (4 to 10). Ensure it includes:
- Clause-by-clause breakdown
- Compliance ratings (Conformant, Partial, Non-Conformant)
- Fields for findings, observations, and comments
- Photo/document upload capabilities
- Corrective action assignment sections
- Tags for audit type, department, or risk
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Conducting the ISO 9001 2015 Audit Using eAuditor
2.1 Evaluate Each Clause of ISO 9001 2015
Clause 4: Context of the Organization
- Has the organization identified internal/external issues?
- Are the interested parties and their requirements documented?
- Is the QMS scope clearly defined?
Clause 5: Leadership
- Is the quality policy appropriate and communicated?
- Has top management demonstrated leadership and accountability?
- Are roles and responsibilities defined?
Clause 6: Planning
- Are risks and opportunities identified and addressed?
- Are quality objectives measurable and aligned with the policy?
- Is planning documented and monitored?
Clause 7: Support
- Are adequate resources and competent personnel provided?
- Is awareness and communication well-managed?
- Is the documented information controlled?
Clause 8: Operation
- Are operational processes planned, implemented, and controlled?
- Have customer requirements been determined and met?
- Are nonconforming products managed properly?
Clause 9: Performance Evaluation
- Is performance monitored through KPIs?
- Are internal audits and management reviews conducted regularly?
Clause 10: Improvement
- Are corrective actions implemented for nonconformities?
- Is there a process for continual improvement?
2.2 Record Findings in Real Time
- Use eAuditor on a mobile device or desktop to:
- Log responses and audit notes per clause
- Upload photographic or document-based evidence
- Mark findings as compliant, partial, or noncompliant
- Use digital signatures, timestamps, and GPS for traceability
2.3 Collaborate with Relevant Departments
- Share the audit form with QA managers, department heads, or process owners
- Use @mentions to tag stakeholders in key findings
- Assign in-app corrective actions instantly
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Post-Audit Actions and Reporting
3.1 Generate the ISO 9001 2015 Audit Report
eAuditor automatically compiles a full audit report featuring:
- Clause-by-clause findings and compliance status
- Highlighted nonconformities and risks
- Evidence: photos, documents, and commentary
- Corrective actions with assigned owners and due dates
- Audit score, status, and location details
- Export formats: PDF, Excel, or secure web links
3.2 Assign and Track Corrective Actions
- Create actions directly from nonconformities
- Assign to the responsible team members
- Set deadlines, attach files, and update statuses
- Monitor open vs. closed actions in real time
3.3 Analyze Audit Data with eAuditor Analytics
- Use visual dashboards to:
- Track audit trends by clause, team, or site
- Identify frequently recurring nonconformities
- Compare audit scores across locations
- Monitor overdue corrective actions
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Key Areas to Include in the ISO 9001 2015 eAuditor Checklist
- Organizational context and interested parties
- Quality policy and leadership commitment
- Quality objectives and risk planning
- Staff training, competence, and awareness
- Product/service delivery controls
- Customer satisfaction and complaint handling
- Internal audit program and management review
- Corrective actions and continuous improvement logs
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Benefits of Using eAuditor for ISO 9001 2015 Audit
- Standardized audit templates aligned with ISO clauses
- Real-time data collection with offline capability
- Embedded photos and documentation as audit evidence
- Instant audit reports ready for management or certification bodies
- Corrective action tracking with full accountability
- Analytics dashboard to monitor audit trends and performance
- Cloud-based access to all records and audit trails
Summary
Performing an ISO 9001 2015 Audit using eAuditor streamlines QMS evaluations by digitizing the entire process—from clause-level checks to evidence collection and action tracking. It ensures your quality system is aligned with the standard, supports audit readiness, promotes transparency, and drives continual improvement across all operations.