A Comprehensive Guide to Building an ISO 9001 Audit Plan

Achieving ISO 9001:2015 certification is a significant milestone, but maintaining it requires more than just documented processes—it demands regular, strategic audits. The ISO 9001 audits go beyond compliance checks and serve as powerful tools to identify inefficiencies, enhance operational performance, and foster continuous improvement.

Read on to learn more about the ISO 9001:2015 standard, the pivotal role of audits in maintaining it, and how to conduct effective ISO 9001 internal audits with digital software.

Understanding ISO 9001:2015 Standard

ISO 9001:2015 is a globally recognized standard set by the International Organization for Standardization (ISO) that outlines the requirements for a Quality Management System (QMS). Its primary goal is to enhance an organization’s ability to consistently deliver products and services that meet customer requirements and expectations.

Importance of ISO 9001:2015 in Quality Management 

ISO 9001:2015 emphasizes the importance of a systematic approach to quality management. The standard helps organizations ensure their processes are efficient, consistent, and continuously improving.

By adopting ISO 9001, companies can provide a consistent product or service, meet customer expectations, comply with regulatory requirements, and continually improve processes. This, in turn, leads to higher customer satisfaction, better performance, and more efficient resource use.

Role of ISO 9001:2015 Audits

ISO 9001:2015 audits act as a strategic checkpoint, ensuring an organization’s QMS meets international ISO standards and adapts to evolving business needs. More than just a compliance exercise, these audits uncover opportunities for process optimization, risk mitigation, and sustainable growth, creating a culture of quality that extends beyond certifications.

There are three key types of ISO audits: internal audits, conducted by the organization to monitor QMS performance; external audits, carried out by certification bodies to verify ISO compliance; and supplier audits, which assess suppliers’ quality management practices.

The ISO 9001:2015 certification audit cycle includes the following stages:

• ISO 9001 Stage 1 audit for documentation review.
• ISO 9001 Stage 2 audit which is an on-site assessment.
• ISO 9001:2015 surveillance audits are conducted annually to verify ongoing compliance.
• ISO 9001 recertification audits are conducted every three years to maintain certification and continuous improvement.

Benefits of Conducting Regular ISO 9001 Internal Audits

Conducting regular ISO 9001 internal audits brings several benefits to an organization:

• Ensuring Compliance: ISO 9001 self-inspections ensure that the company remains compliant with the required standards. This compliance is crucial for maintaining certifications and demonstrating to stakeholders that the organization is committed to maintaining high-quality standards.
• Identifying Areas of Improvement: Regular audits help identify gaps or inefficiencies in the organization’s processes. These insights can lead to improvements in the QMS, such as streamlining workflows, enhancing communication, or resolving issues before they escalate.
• Customer Satisfaction: By identifying potential issues and rectifying them through internal audits, you can enhance the overall customer experience. A well-maintained QMS leads to the production of high-quality products and services, which results in higher customer satisfaction, loyalty, and retention.
• Reputation: ISO 9001 certification and regular internal audits bolster a company’s reputation. They show that the organization is committed to quality and consistently evaluates its practices to ensure efficiency and effectiveness. This reputation can lead to better business relationships, improved market positioning, and a competitive edge in the industry.

ISO 9001 Internal Audit Plan: How to Conduct an ISO 9001:2015 Internal Audit?

Implementing a successful ISO 9001 internal audit process requires careful planning, execution, and follow-up. Here is a step-by-step guide on how to conduct an ISO 9001:2015 internal audit:

Planning as Per the ISO 9001 Internal Audit Requirements

According to ISO 9001:2015, organizations are required to establish an internal audit plan that aligns with their QMS requirements. This audit plan is not just a formality—it serves as a strategic tool to ensure continuous improvement, compliance, and operational efficiency.

An effective ISO 9001 audit plan should clearly define the scope, objectives, and frequency. Additionally, it should specify the resources needed, such as time, personnel, and tools required for thorough audits.

Another critical element is the selection of qualified auditors. Auditors should have a deep understanding of ISO 9001 standards and the organization’s specific processes to ensure objective, comprehensive evaluations. The plan should also consider risk-based thinking, focusing more on areas with higher risks to product or service quality.

Lastly, the audit plan should be flexible, allowing adjustments based on organizational changes, audit outcomes, and evolving risks. This dynamic approach ensures that the internal audit process remains relevant, proactive, and aligned with the organization’s quality objectives.

Conducting the Audit

Once the audit plan is in place, auditors can begin the assessment process. Auditors must review processes, procedures, and records to ensure compliance with ISO 9001:2015. Interviews with staff members, process walkthroughs, and document reviews help gather the necessary evidence.

Auditors can use checklists to ensure thorough coverage of all ISO 9001 requirements. The digital checklists combined with the ISO 9001 auditing app allow auditors to record findings in real time, capture photos, and share reports directly with the team, streamlining the process and improving accuracy.

Reporting Audit Findings

After conducting the audit, the auditors must compile a report that outlines the findings. This report should include both positive and negative observations, along with any non-conformities or areas requiring corrective action.

With quality inspection software like GoAudits, auditors can generate reports that are pre-populated with attached reports, assigned actions, time stamps, geo-location, and more. The reports can also be emailed to the department heads and quality assurance officers within the app.

Corrective Action and Follow-Up

Once the audit findings are reported, corrective actions must be taken to address any non-conformities or inefficiencies. Corrective action plans should specify the steps that will be taken to resolve issues, timelines for implementation, and the individuals responsible for executing the actions. 

After corrective actions have been implemented, follow-up audits are necessary to ensure that the changes are effective and that the issue has been fully resolved.

Best Practices to Build an ISO 9001 Internal Audit Program

Here are some recommended practices and tips for effective internal audits and the overall QMS as per the ISO 9001 inspection standards:

Implement an Internal Audit Schedule

An internal audit schedule helps ensure that audits are conducted regularly and consistently. By setting a timetable for audits, organizations can plan for the necessary resources and ensure that audits cover all relevant processes. Scheduling audits at regular intervals also guarantees that the QMS remains up-to-date and continuously evaluated.

Mandate Usage of ISO 9001 Audit Process Checklists

Audit checklists are useful tools for auditors to ensure they cover all relevant areas during the audit. ISO 9001 audit procedure checklists help confirm that each aspect of the standard is assessed and that no key area is overlooked. These checklists can be customized to fit the organization’s specific processes and can help streamline the auditing process.

Use ISO Internal Audit Management Software

ISO audit software allows for easier scheduling, documentation, and tracking of audit findings. It can also help manage corrective actions, monitor the implementation of improvements, and provide a centralized repository for audit reports and other related documents.

This software ensures that the internal audit program is managed efficiently and that all audits are documented in compliance with ISO 9001:2015.