Checklist template

ISO Gap Analysis

A ready-to-use checklist with 37 items in 6 sections, covering Context of the Organization, Leadership & Governance, Planning & Risk Management, Support & Competence, Operation & Control, Performance Evaluation & Improvement. Use it as-is in InspectLoop, or adapt it to your own standards in minutes.

  • 6 Sections
  • 37 Items
  • 30 Yes / No checks
  • 6 Scored ratings
  • 340 Points

Use this template How audits work

1. Context of the Organization 6 items

  1. Has the organization formally documented its internal and external issues relevant to its strategic direction? Yes / No 10 pts
  2. Are the requirements and expectations of all interested parties (customers, regulators, shareholders) identified? Yes / No 9 pts
  3. Is the scope of the Management System clearly defined, documented, and physically or digitally accessible? Yes / No 10 pts
  4. Are the core operational processes mapped out along with their inputs, outputs, and interdependencies? Yes / No 9 pts
  5. Has the scope of the system been reviewed within the last 12 months to reflect business changes? Yes / No 8 pts
  6. Organizational Alignment: Rating
    • Strategic Scope Defined 10 pts
    • Process Mapping Incomplete 5 pts
    • Scope Undefined 0 pts

2. Leadership & Governance 6 items

  1. Has top management demonstrated commitment by establishing and signing a formal corporate policy? Yes / No 10 pts
  2. Are organizational roles, responsibilities, and authorities clearly assigned, communicated, and understood? Yes / No 10 pts
  3. Does leadership ensure that the management system requirements are integrated into core business processes? Yes / No 9 pts
  4. Are resource requirements (human, infrastructure, environmental) reviewed and approved by executive management? Yes / No 9 pts
  5. Is there a designated Management Representative or steering committee actively overseeing compliance? Yes / No 8 pts
  6. Leadership Commitment: Rating
    • Fully Engaged 10 pts
    • Governance Gaps 5 pts
    • Deficient Oversight 0 pts

3. Planning & Risk Management 6 items

  1. Is there a structured framework to identify risks and opportunities that could affect performance? Yes / No 10 pts
  2. Are formal action plans documented to mitigate identified risks and exploit strategic opportunities? Yes / No 10 pts
  3. Are measurable objectives established at relevant functional levels and aligned with corporate policy? Yes / No 9 pts
  4. Do corporate objectives explicitly state what will be done, what resources are required, and who is responsible? Yes / No 9 pts
  5. Is there a documented process for managing organizational changes to preserve system integrity? Yes / No 8 pts
  6. Risk Architecture: Rating
    • Proactive/Risk-Based 10 pts
    • Reactive Planning 5 pts
    • No Formal Risk Control 0 pts

4. Support & Competence 6 items

  1. Are competence requirements defined for personnel performing work affecting system performance? Yes / No 9 pts
  2. Is there verifiable evidence (training logs, certifications, CVs) of employee competence on file? Yes / No 10 pts
  3. Have targeted awareness sessions been conducted regarding the policy, objectives, and individual contributions? Yes / No 8 pts
  4. Are internal and external communication protocols (what, when, whom, and how to communicate) defined? Yes / No 8 pts
  5. Is a formal process established to control documented information (creation, update, distribution, and retention)? Yes / No 10 pts
  6. Resource Readiness: Rating
    • Certified & Controlled 10 pts
    • Administrative Lag 5 pts
    • Competence Unverified 0 pts

5. Operation & Control 6 items

  1. Are operational processes planned, implemented, and controlled using documented criteria? Yes / No 10 pts
  2. Are outsourced processes or vendor dependencies clearly identified, monitored, and controlled? Yes / No 10 pts
  3. Is there a formal process to review and control unintended operational changes to minimize negative impacts? Yes / No 9 pts
  4. Are product or service requirements clearly reviewed and confirmed before commitment to customers? Yes / No 9 pts
  5. Is there a structured system to manage and segregate non-conforming outputs to prevent unintended use? Yes / No 10 pts
  6. Operational Rigor: Rating
    • Process Controlled 10 pts
    • Minor Control Gaps 5 pts
    • Uncontrolled Variations 0 pts

6. Performance Evaluation & Improvement 7 items

  1. Are monitoring, measurement, analysis, and evaluation methods defined to track system health? Yes / No 10 pts
  2. Is customer satisfaction actively monitored, analyzed, and treated as a key performance indicator? Yes / No 9 pts
  3. Is an internal audit program planned, established, and executed at scheduled intervals? Yes / No 10 pts
  4. Are management reviews conducted regularly by executive leadership to evaluate system suitability? Yes / No 10 pts
  5. Is there a formal corrective action system to address non-conformities and prevent recurrence? Yes / No 10 pts
  6. Continuous Improvement: Rating
    • Optimization Driven 10 pts
    • Assessment Lags 5 pts
    • No Evaluation Framework 0 pts
  7. Final summary Comments

About this template

This checklist is part of the InspectLoop template library. Yes / No checks score 1 point when met; ratings score the points shown for each option. The overall score is the percentage of points earned, with N/A answers excluded. In InspectLoop you can add photos, assign corrective actions, require sign-off and compare results across sites.

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