The Complete Guide to Internal Quality Audits: What, Why, and How to Succeed

Is your team regularly checking your quality process or system, or are you relying on assumptions and guesswork?

‘A strong internal quality audit keeps the foundation of any business steady.’

The statement feels true in the context of modern organizations striving to outpace their competitors in this customer-centric marketplace.

Internal quality audits not only verify whether the organization is adhering to internal policies, industry standards, and legal regulations but also ensure transparency and the long-term success of a business.

A robust internal quality audit is like the preventive maintenance of a high-performance machine. Just as regular maintenance helps keep a machine running smoothly, efficiently, and safely, preventing unexpected breakdowns—regular internal audits ensure that business processes constantly meet quality standards and avoid potential failures before they occur.

What is an internal quality audit, why is it important, and how to conduct it effectively? Let’s uncover some of the key aspects related to internal quality audits.

What is an internal quality audit?

An internal quality audit is a well-structured, independent review of the processes and quality management system conducted within the organization to ensure they align with internal and external quality guidelines and regulatory standards.

According to the global regulatory standards like ISO 9001 (clause 9.2.2) and 9004 (clause 10.5):

“The organization shall plan, establish, implement and maintain an audit program(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits.”

Furthermore, ISO 9001 emphasizes applying risk-based thinking to internal audit programs by focusing on processes and areas with a history of problems, ongoing issues, or a high likelihood of future nonconformities to help prioritize audit efforts.

Simply put, internal quality audits not only ensure that processes are executed as planned and are strictly aligned with the set standards but also identify ways to further improve and exceed the quality expectations of end-users.

Let’s understand the importance of internal quality auditing.

Understanding the Importance of Internal Quality Audits

1. Ensures compliance with standards and regulations

While planning an internal audit, organizations clearly outline the standards by which the existing processes and systems will be evaluated. It compares the processes and systems against established procedures, standards, and legal requirements, with the aim of proactively identifying gaps and recording nonconformities, ultimately ensuring compliance in the long run.

2. Identifies nonconformities and risks early

Regular internal audits play a crucial role in identifying issues early that can escalate into more significant problems. Indeed, even minor problems, including incomplete records, missed approvals, or incorrect measurements, can turn into bigger failures. Furthermore, it encourages quality teams to proactively report issues, thereby creating a culture where risks are quickly identified and addressed.

3. Drives continuous improvements

Internal auditing not only checks for nonconformance and deviations but also analyzes trends and spots patterns by reviewing previous audit data and performance metrics. Additionally, the detailed audit reports provide a comprehensive overview of how various aspects of your quality management, including training, technology, processes, and resources, can be improved to achieve better results.

4. Prepares for external audits

Internal audits procedures replicate the standards followed in an external audit. By ensuring clear, well-structured documentation, internal audits make external audits smoother, and more importantly, they help identify issues before external auditors do. This further enhances your audit preparedness and reduces the risk of non-compliance with findings and penalties.

5. Validates the effectiveness of corrective actions

When nonconformities arise, organizations take corrective and preventive actions to fix them and prevent them from happening. Again, how will you ensure those measures align with the set internal audit procedures and compliance?

Certainly, an effective internal quality audit examines the real cause, seeks a logical explanation for the actions taken, and reviews records and revised standards—ensuring that the CAPA process was not just reactive but truly effective.

Who Conducts Internal Quality Audits?

In regulated industries such as pharmaceuticals, healthcare, or manufacturing, internal quality audits are typically conducted by trained professionals within the organization. Often, these professionals are part of quality teams or from the compliance or quality control department.

ISO 9001 offers a clear guideline for selecting an internal auditor:

• Must be independent (not auditing their own work)
• Should be competent and trained in auditing
• Must understand the relevant processes and standards
• Should act impartially and objectively
• Aim to support continual improvement

Apart from a significant set of qualities, an internal quality auditor must:

• Understands the business process
• Informed about the industry-specific quality benchmarks
• Familiar with compliance and regulatory requirements

How to Conduct Internal Quality Audits and How a QMS Can Be Helpful

An effective internal quality audit process does more than check compliance—it drives real operational improvement. Below, we break down clear and practical internal audit procedures to help you carry out audits with greater confidence, consistency, and results.

1. Plan the audits

Planning the internal audit is the first crucial step. You can start by identifying which area, process, system, or department will be audited and against which compliance standards. The planning phase must also be utilized to define audit frequency, choose qualified auditors, and set internal benchmarks that will be considered a single source of truth throughout the process.

While you can always leverage a digital platform to create timelines, assign responsibilities, track tasks, and send reminders, it can also be used as a centralized space to create custom templates and store and access regulatory standards and related documentation.

2. Preparing for the audit

The internal auditors or responsible teams must collect all relevant records, documentation, quality manuals, previous audit reports, process maps, and other relevant materials for the areas being audited. These documents are evaluated for their alignment with established policies or standards. You can also create a detailed quality audit checklist to ensure consistent evaluation throughout the audit process.

A digital QMS eases this by offering features like metadata integration, dedicated repositories, detailed activity logs, and lists—allowing quick retrieval of essential documents. You can also create dedicated SOP libraries, standardize templates for different audit types, and create version-controlled quality audit checklists for auditors to save time, improve accuracy, and ensure readiness.

3. Conduct the audit

At this stage, internal auditors directly engage with the actual processes, records, or systems to gather necessary evidence for assessing compliance, effectiveness, and areas of improvement. They review historical records and documentation and verify the authenticity of the actions taken during a specific process.

In a SharePoint environment, you can streamline the audit execution process by allowing internal auditors to access work manuals, protocols, and SOPs; review version-controlled records; and track timestamped actions—all in one place. This ensures faster and more traceable internal audits.

4. Document and report findings

Once the audit is conducted and all the relevant evidence is gathered, documenting and reporting those audit findings becomes important. The primary aim of this phase is to convert the raw observations into detailed, actionable insights.

Apart from the basic overview, an audit report consists of clearly described issues, observations, severity levels, affected processes or records, recommendations, and, most importantly, opportunities for further improvement.

However, by using pre-built templates and workflow automation, auditors can not only document the findings but also route them to designated authorities for review, approval, or feedback. Also, an integrated QMS that fosters cross-functional collaboration offers a significant advantage in assessing audit findings and effectively planning corrective actions based on their recommendations.

5. Take corrective actions and follow up

Once all the audit findings are in front of you, it’s important to make a shift from identifying issues to resolving them. From nonconformities to recommendations, every issue is not only acknowledged systematically but is prevented from reoccurring.

The focus should be on eliminating the root cause instead of treating the symptoms. Similarly, implementing corrective and preventive actions, verifying their effectiveness, planning a follow-up audit or review, and formally closing the audit loop are among the few crucial steps that need to be performed.

You start by assigning clear roles and responsibilities to individuals or teams, setting priorities, monitoring progress, or adding reminders to help them stay on track. Also, changing SOPs or protocols based on the audit findings and training employees for changed processes becomes essential to prevent such issues from recurring.

If you are in a SharePoint environment, you can easily define a document retention policy and store all the audit documentation for future reference.

Internal Quality Audit Tips to Identify and Eliminate Gaps

1. Audit with purpose

Instead of treating it as a routine task, organizations must carefully plan and define the purpose of an internal quality audit. Not only the processes but also the quality management system and its effectiveness should be part of the audit process.

Try to identify areas that have changed recently or are lacking efficiency. For instance, if you are seeing delays in order fulfillment, include supply chain-related processes in your audit scope.

2. Centralize audit planning

Decentralized planning can lead to misalignment and ineffective audits. Select a single centralized location for audit-related activities, or you can come up with a dedicated audit management module to further streamline the internal audit procedure.

Centralize your quality audit checklists, schedules, planning templates, documentation, records, and related tasks, and allow your cross-functional teams to access, modify, and share them effectively within the organization.

3. Use the latest process information

Outdated information can lead to unfair assessment, thereby defeating the overall purpose of the auditing process. Ensure that the audit teams have access to the most updated version of the documentation that reflects the actual process.

You can leverage document control features, document versioning, audit trails, and metadata integration to improve the accuracy of the audits and reduce rework and miscommunication.

4. Review past findings and actions

Each action taken in the past offers context for understanding the issue more deeply and identifying any recurrence. What issues were previously found, what corrective actions were taken, and were those actions implemented effectively?

Allow your auditing teams to access and analyze previous audit records and data to identify long-term trends and plan accordingly. An interactive dashboard could be the right tool for this.

5. Audit the QMS itself

Make your QMS part of the internal audit, just like any other process. Is it helping your team stay compliant, act on issues quickly, and maintain accurate, trustworthy records across your quality processes?

A QMS internal audit is not just about having workflows and records—it’s about how well the system actually supports your team. Check user adoption, ease of access, and how smoothly actions flow in an effective internal quality audit.

BizPortals QMS: Transforming the Way You Manage Internal Quality Audits

BizPortals QMS, a SharePoint-based quality management system, is here to help you streamline your internal quality auditing process.

Its features, like robust document control, configurable modules, custom internal audit templates, dedicated activity logs, cross-module integration, and automated workflows, not only offer a seamless auditing experience but also empower you to fully control your processes and align them with your organizational objectives.

Leverage a digital, secure, and centralized platform that fosters a culture of accountability, ensures compliance, and supports long-term organizational success.

Curious how BizPortals can elevate your internal quality audits? Book a free session with our experts and explore its powerful, transformative features firsthand.