Get Started For Free

Perform ISO 9001-2015 Gap Analysis Assessment using eAuditor

ISO 9001-2015 Gap Analysis is a structured assessment used to compare an organization’s current quality management system (QMS) against the requirements of the ISO 9001-2015 standard. The goal is to identify gaps, or areas where the existing processes do not meet the standard, so that targeted improvements can be made before pursuing certification or recertification.

Performing an ISO 9001-2015 Gap Analysis Assessment using eAuditor ensures a thorough evaluation of an organization’s Quality Management System (QMS) against the requirements of the ISO 9001-2015 standard. It helps uncover non-conformities, partial alignments, and areas of opportunity within existing systems while maintaining a clear trail of digital evidence, corrective actions, and continual improvement efforts. eAuditor’s cloud-based features empower organizations to conduct efficient, clause-by-clause assessments with real-time collaboration, detailed analytics, and streamlined reporting—preparing for both internal reviews and third-party certification audits.

1. Preparing for the ISO 9001-2015 Gap Analysis in eAuditor

1.1 Define Audit Goals and Scope

• Clarify the purpose of the gap analysis:
  • Pre-certification assessment
  • Internal audit benchmarking
  • Surveillance audit preparation
• Determine organizational scope:
  • Site-wide or department-specific
  • Entire QMS or selected clauses
• Identify key stakeholders:
  • Process owners
  • Department heads
  • Senior management

1.2 Review ISO 9001-2015 Standard Requirements

• Break down the 10 clauses of ISO 9001-2015 into audit-ready elements:
  • Clause 4: Context of the Organization
  • Clause 5: Leadership
  • 6th Clause: Planning
  • Clause 7: Support
  • Clause 8: Operation
  • 9th Clause : Performance Evaluation
  • Clause 10: Improvement

1.3 Prepare Internal Documentation

• Collect current QMS-related documents:
  • Policies, procedures, and work instructions
  • Risk assessments and quality objectives
  • Audit reports and management review records
  • Training logs and competency records
  • Customer feedback and complaint logs

1.4 Set Up eAuditor for the Audit

• Customize or download a ready-made ISO 9001-2015 checklist template from the eAuditor Public Library.
• Include:
  • Clause references
  • Clear compliance criteria
  • Scoring system (Compliant, Partial, Non-Compliant, N/A)
  • Comment sections for auditor notes
  • Evidence capture fields (images, attachments, GPS)
  • Action creation section for immediate non-conformity handling

2. Performing the Gap Analysis Using eAuditor

2.1 Conduct On-Site or Remote Inspections

• Open the checklist via the eAuditor mobile or desktop app.
• Review processes and records against each ISO 9001-2015 clause.
• Use structured audit questions to assess:
  • Documented procedures and records
  • Process implementation and consistency
  • Employee awareness and engagement
• Rate each item:
  • Compliant: Fully meets ISO 9001 requirements
  • Partially Compliant: Incomplete or inconsistently applied
  • Non-Compliant: Missing or ineffective
  • Not Applicable: Clause not relevant to business scope

2.2 Document Observations in Real Time

• Capture detailed evidence for each gap:
  • Photos of records, processes, or conditions
  • Voice notes or typed observations
  • Embedded hyperlinks to digital documentation
• Tag departments or individuals responsible
• Use the GPS and time-stamping feature for audit integrity

2.3 Collaborate Across Teams

• Enable live syncing so multiple auditors can contribute simultaneously.
• Notify relevant stakeholders of findings instantly.
• Discuss observations and assign follow-up actions within the app.
• Use digital signatures for acknowledgment and verification.

3. Post-Audit Activities in eAuditor

3.1 Generate Automated Reports

• Create instant reports with full clause-by-clause breakdown:
  • Compliance percentage per clause
  • Non-conformity heatmaps
  • Attached visual and written evidence
• Export in preferred formats:
  • PDF for sharing with auditors and management
  • Web link for live collaboration
  • Excel for data manipulation

3.2 Assign and Track Corrective Actions

• For each gap identified:
  • Create a Corrective or Preventive Action (CAPA) task
  • Assign it to the appropriate individual or department
  • Set priority levels: High, Medium, Low
  • Define clear deadlines for resolution
• Enable real-time tracking:
  • Audit trail of action updates
  • Status labels: Open, In Progress, Overdue, Closed
  • Notifications and reminders for pending tasks

3.3 Analyze and Monitor Results

• Use eAuditor’s analytics dashboard to:
  • View performance trends across audits
  • Compare compliance across multiple teams or locations
  • Identify recurring non-conformities
  • Highlight top-risk clauses or departments
• Schedule follow-up audits to ensure continuous improvement

4. Breakdown of ISO 9001-2015 Clauses in the eAuditor Checklist

Clause 4 – Context of the Organization

• Are internal and external issues documented?
• Have interested parties been identified?
• Is the QMS scope clearly defined and justified?

Clause 5 – Leadership

• Is the quality policy aligned with business strategy?
• Is leadership actively promoting process-based approaches?
• Are responsibilities and authorities clearly defined?

Clause 6 – Planning

• Are risks and opportunities identified and addressed?
• Are measurable quality objectives set and monitored?
• Is there a documented plan for change management?

Clause 7 – Support

• Are adequate resources available (people, infrastructure)?
• Is there a system for training and evaluating competence?
• Is communication structured and effective?

Clause 8 – Operation

• Are operational processes planned and controlled?
• Have customer requirements been reviewed and met?
• Are design, procurement, and production processes compliant?

Clause 9 – Performance Evaluation

• Are monitoring and measurement tools effective?
• Have internal audits been scheduled and performed?
• Are management reviews comprehensive?

Clause 10 – Improvement

• Are non-conformities handled with documented actions?
• Is there a process for continual improvement?
• Are corrective actions evaluated for effectiveness?

5. Benefits of Using eAuditor for ISO 9001-2015 Gap Analysis

• Structured clause-by-clause reviews with clear visual dashboards
• Mobile-first auditing—conduct audits directly on phones or tablets
• Multimedia evidence capture to strengthen findings
• Instant corrective action assignment with reminders and status tracking
• Powerful data analytics for identifying patterns and improvement areas
• Audit trail storage for certification or surveillance audit readiness
• Multi-location standardization using cloned templates and comparative reporting

Summary

Using eAuditor to perform an ISO 9001-2015 Gap Analysis Assessment transforms the traditional, paperwork-heavy process into a dynamic, digital quality assurance solution. Every clause of the ISO standard is systematically reviewed with detailed observations, photo evidence, and automatic action tracking, enabling organizations to eliminate inefficiencies, ensure compliance, and continuously improve their QMS. With real-time collaboration, transparent reporting, and data-driven insights, eAuditor supports both large-scale enterprises and small businesses in achieving ISO 9001-2015 alignment with confidence and agility.

Get Started For Free