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ISO 9001 gap analysis checklist template

ISO 9001 gap analysis checklist template

Conduct a thorough gap analysis of your quality management system based on ISO 9001 requirements and prepare for successful certification.

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The Lumiform application helps frontline teams uphold internal standards effortlessly.
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ISO 9001 gap analysis checklist template

Conduct a thorough gap analysis of your quality management system based on ISO 9001 requirements and prepare for successful certification.

Use this template with Lumiform

The Lumiform application helps frontline teams uphold internal standards effortlessly.
  • Customize this template or build your own
  • Fill out templates via mobile app
  • Assign and track corrective actions
  • Get reports and analyse your data
Prices start from ░░░ per month
Book a demo
Learn more
or Download template as PDF

This ISO 9001 gap analysis checklist turns the complex requirements of ISO 9001 into a practical assessment tool for evaluating your quality management system’s compliance status. By working through the clauses systematically, you gain clear visibility into areas requiring attention before certification.

To keep their certification, organizations need to complete yearly surveillance audits while showing ongoing progress. When facing an upcoming ISO 9001 audit, you can use this checklist to conduct a thorough self-assessment, pinpointing specific gaps in your processes and documentation that might otherwise lead to non-conformities during official certification.

Related categories

  • Quality management templates
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Preview of the template
Page 1
Context of the Organization
Understand the organization and its context
Determine the scope of the quality management system
Identify interested parties and their requirements
Leadership
Top management demonstrates leadership and commitment
The quality policy is established
Organizational roles, responsibilities and authorities are defined
Planning
Actions to address risks and opportunities are planned
Quality objectives and planning to achieve them
Planning of changes
Support
Necessary resources are determined and provided
Competence of personnel is ensured
Awareness of personnel is promoted
Communication needs are determined
Documented information is controlled
Operation
Operational planning and control
Requirements for products and services
Design and development of products and services
Control of externally provided processes, products and services
Production and service provision
Release of products and services
Control of nonconforming outputs
Performance Evaluation
Monitoring, measurement, analysis and evaluation
Internal audit
Management review
Improvement
General
Nonconformity and corrective action
Continual improvement

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Frequently asked questions

How do you prioritize the gaps identified through this checklist?

Prioritize gaps based on their impact on customer satisfaction, product/service quality, and business objectives. Focus first on major non-conformities that would prevent certification, then on items affecting core processes. Consider implementation difficulty, resource requirements, and interdependencies between processes when creating your action plan to address gaps systematically.

What should you do if you find major gaps when using this checklist?

When discovering major gaps, document them thoroughly and develop a structured improvement plan with clear responsibilities and timelines. For complex issues, consider bringing in external expertise or creating focused improvement teams. Break larger gaps into manageable steps and establish regular progress reviews to ensure accountability and maintain momentum toward closing the gaps.

Can you customize this checklist for different departments or processes?

Yes, you can adapt this checklist to focus on specific departments by adding department-specific questions while maintaining the core ISO 9001 requirements. You might include specialized questions for manufacturing, service delivery, or support functions while keeping the structure aligned with the standard. This targeted approach helps make the assessment more relevant and actionable for each area of your organization.

What evidence should you collect when conducting the gap analysis with this checklist?

Collect documented procedures, records of activities, examples of completed forms, interview notes with process owners, observation records, and performance data. For each requirement, gather evidence that demonstrates both the existence of processes and their effectiveness. Having this documentation ready will not only support your gap analysis but also prepare you for formal certification audits.


This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.
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