ISO 9001 GAP Analysis

ISO 9001 is a globally recognized standard for Quality Management Systems (QMS). It provides a framework that organizations can use to establish and maintain processes that consistently meet customer and regulatory requirements. ISO 9001 certification can bring many benefits to an organization, including improved customer satisfaction, increased efficiency, and enhanced reputation. However, before obtaining certification, organizations must conduct a gap analysis to identify areas where their current processes do not align with the standard’s requirements.

What is a Gap Analysis?

A gap analysis is a tool used to compare an organization’s current processes with the requirements of a standard or best practice. In the case of ISO 9001, a gap analysis identifies areas where an organization’s Quality Management System does not meet the requirements of the standard. The analysis provides a roadmap for addressing these gaps and achieving certification.

Conducting an ISO 9001 Gap Analysis

To conduct an ISO 9001 gap analysis, organizations should follow these steps:

  1. Read and Understand the Standard: The first step in conducting an ISO 9001 gap analysis is to read and understand the standard’s requirements. This will provide a foundation for the analysis and ensure that the organization is aware of what is required to meet the standard.
  2. Gather Information: The organization should gather information on its current processes, including policies, procedures, and records. This information will be used to compare the current processes with the standard’s requirements.
  3. Identify the Gaps: Using the information gathered in step two, the organization should identify areas where its processes do not meet the standard’s requirements. This may involve comparing the organization’s processes with the standard’s requirements clause by clause.
  4. Prioritize Gaps: After identifying the gaps, the organization should prioritize them based on their impact on the QMS and the ease of addressing them. This will help the organization focus its resources on the most critical gaps.
  5. Develop an Action Plan: With the gaps identified and prioritized, the organization should develop an action plan for addressing them. The action plan should include specific steps, timelines, and responsible parties for each gap.
  6. Implement the Action Plan: The organization should implement the action plan to address the identified gaps. This may involve developing new policies and procedures, providing training to employees, or making changes to existing processes.
  7. Review and Monitor Progress: Once the action plan is implemented, the organization should review and monitor progress regularly. This will ensure that the changes made are effective and that the QMS continues to meet the standard’s requirements.

Benefits of Conducting an ISO 9001 Gap Analysis

Conducting an ISO 9001 gap analysis can bring several benefits to an organization. These benefits include:

  1. Improved QMS: By identifying gaps and addressing them, the organization can improve its QMS and ensure that it meets the standard’s requirements. This can lead to improved customer satisfaction, increased efficiency, and enhanced reputation.
  2. Cost Savings: Improving the QMS can lead to cost savings through increased efficiency, reduced waste, and fewer errors.
  3. Competitive Advantage: ISO 9001 certification can provide a competitive advantage by demonstrating to customers and stakeholders that the organization is committed to quality and continuous improvement.
  4. Compliance: ISO 9001 certification can help organizations comply with regulatory requirements and contractual obligations.


Conducting an ISO 9001 gap analysis is a critical step for organizations seeking to achieve certification. It provides a roadmap for addressing gaps and improving the QMS, leading to improved customer satisfaction, increased efficiency, and enhanced reputation. By following the steps outlined in this article, organizations can conduct a thorough and effective gap analysis and set themselves on the path to ISO 9001 certification.

Contact us to help build your ISO 9001 Management System including a GAP Analysis.