Conducting and Preparing for ISO 9001 Internal Audits with Checklists and Procedures

Internal audits are vital for compliance and improvement, but SMEs often face challenges in managing them. Many struggle with tracking complex audit requirements, leading to incomplete audits and missed details. Scheduling can also be overwhelming, and without a proper system, documenting results can become disorganized and hard to interpret.

For SMEs, these issues can be tough due to limited resources. However, using automation software for scheduling and documentation, along with training audit teams, can streamline the process and reduce errors, making audits more efficient and manageable.

This blog will guide you through preparing for and conducting ISO 9001 internal audits effectively. You’ll learn how to avoid common pitfalls and create checklists to stay on track. But first, let’s understand what this internal audit means, even.

What is an ISO 9001 Audit Checklist?

An ISO 9001 audit checklist guides auditors through the internal audit process. It helps to verify all required areas of the ISO 9001 standard are covered. This checklist serves as a roadmap, making sure you don’t miss any critical audit steps.

Using an ISO 9001 internal audit checklist improves consistency in your organization’s Quality Management System (QMS). It helps you track compliance and identify areas needing improvement. With a checklist in hand, the audit process becomes more organized and efficient. 

But what will happen if you don’t use an ISO 9001 checklist? To understand this, you need to know about the impact it can have on your organization.

How does ISO 9001 Affect Your Organization?

Did you know that 85% of certified organizations experience benefits such as enhanced company reputation, increased demand for their products and services, and a larger market share? So, having an ISO 9001 internal audit checklist brings profits at different stages of your audit process. 

From initial efficiency gains to long-term improvements in compliance and market positioning, this tool helps elevate your organization’s performance. Here’s what you can expect from an internal audit:

• Early Stage: In the beginning, a checklist improves efficiency by organizing tasks, saving time, and reducing errors.
• Mid-Term: As you progress, it ensures consistency, making it easier to track compliance with ISO 9001 standards.
• Later Stages: Over time, the checklist helps improve documentation, resulting in more accurate audit records and fewer missed points.
• Long-Term: Ultimately, it improves your company’s reputation, attracts more customers, and boosts your market share.

Next, we will discuss the types of ISO 9001 Audits. Ready to move on?

Types of ISO 9001 Audits

ISO 9001 audits can be categorized into two main types: internal audits and external audits. Each serves a different purpose, but both are essential to maintaining compliance and improving processes.

Internal Audits

These audits are conducted within your organization. They help assess how well your processes align with ISO 9001 standards and internal procedures. Internal audits provide a chance to identify areas for improvement before any external reviews. Conducted by an organization’s own members, internal audits compare the company’s Quality Management System (QMS) to industry standards, such as ISO 9001. 

External Audits

These audits are performed by third parties, such as certification bodies, customers, or suppliers. External audits verify that your organization is complying with ISO 9001 standards. They are essential for certification and maintaining market trust. 

Since, for now, you are aiming for ISO 9001 internal audits, what are the requirements your organization must comply with? Let’s find out.

How to Conduct an ISO 9001 Internal Audit: Know the Requirements

With ISO 9001 audits, organizations face Fewer Losses and Defects and improve their profitability. These are your main goals as an industry leader, too. But how will you achieve these results? Follow the requirements listed below to check if your organization is ready to have an internal audit:

1. Plan and Maintain the Organization’s Audit Program
The audit program must outline the frequency, methods, and the individuals responsible for conducting audits. It should also verify that past audit results and recommendations are addressed and acted upon.

• The quality manager oversees the program, sets the audit requirements, and establishes reporting mechanisms to ensure audit findings are properly implemented.
• The program helps evaluate the QMS’s performance against the ISO 9001 standards.

2. Understand the Context of the Organization
Evaluate the internal and external factors that impact your ability to achieve desired results. This understanding guides the internal audit’s focus and scope.

3. Top Management Commitment to Quality
Top management must demonstrate leadership in quality. They should take responsibility for the QMS's effectiveness and integrate QMS requirements across all organizational processes.

4. Customer Focus
The organization should continuously monitor customer feedback and perceptions to understand their needs. Internal audits will assess how well the QMS supports customer satisfaction.

5. Adequate Resources
Ensure the necessary resources are provided to implement and maintain the QMS. This includes people, infrastructure, training, and monitoring tools.

6. Employee Competence
Internal audits should verify that employees are adequately trained and competent based on their skills, experience, and the training provided.

7. Quality Planning
Quality planning involves controlling the processes that meet product and service requirements. Internal audits ensure the planning process aligns with the desired outcomes.

8. Design of Products and Services
Internal audits will assess whether the design process is effectively planned and controlled to avoid errors and meet intended outcomes.

9. Processes to Resolve Customer Complaints
There must be a system to receive and document customer complaints. Auditors check whether the process includes identifying root causes and resolving issues.

10. Corrective Actions
Internal audits verify that non-conformities are addressed. The audit should evaluate whether corrective actions are taken to prevent recurrence.

11. Assessing Process Conformity
Internal audits evaluate whether processes meet ISO 9001 requirements and identify any deviations or nonconformities. Any identified gaps should be addressed immediately.

12. Evaluating Performance for Continuous Improvement
Internal audits assess the effectiveness of the QMS and identify areas for further improvement. This will guide the path for continuous improvement.

Auditors identify non-conformities before the external audit, allowing your organization time to correct them. By maintaining these twelve requirements, you can be prepared for an internal audit and are ready to conduct one. Now, getting prepared for the audit might seem hectic due to your busy schedule. 

Let BPR Hub help your business focus on what matters most. Their all-in-one solution for multiple standards works seamlessly for busy leaders like you.

Preparation of an ISO 9001 Audit Checklist

Preparing for an ISO 9001 internal audit requires a structured approach. This checklist will guide you through six critical steps in the preparation process, with key questions to ask at each stage. Each step builds on the previous one so that you can conduct a thorough audit.

Step 1: Understand the Scope of the Audit

Before starting, it's essential to define the scope of the audit. This step involves understanding the specific areas to be audited and the boundaries of the Quality Management System (QMS).

Example Questions:

• Have the key processes in the organization been identified for this audit?

• Have there been any changes in the QMS since the last audit that need to be reviewed?

• What specific areas of the organization require a deeper audit focus?

• Is there any new legislation or regulation that could impact the audit?

• Are there any customer complaints or issues that need to be included in the audit?

Step 2: Review Relevant Documentation

This step involves reviewing key documents and records related to the QMS. Documentation should align with ISO 9001 standards and reflect the organization’s actual practices.

Example Questions:

• Has the latest version of the QMS documentation been reviewed?

• Are the procedures in place to manage non-conformities and corrective actions up to date?

• Does the audit include reviewing previous audit findings and corrective actions?

• Are training records for employees being audited available and complete?

• Have you reviewed past performance data to identify areas of focus?

Step 3: Identify and Select Auditors

Choosing the right auditors for the internal audit is crucial. Auditors must have a clear understanding of ISO 9001 standards and be impartial.

Example Questions:

• Are the selected auditors independent of the areas being audited?

• Do the auditors have the necessary expertise and training in ISO 9001?

• Have the auditors been briefed on the scope and objectives of the audit?

• Are the auditors familiar with the organization’s processes and procedures?

• Are all auditors equipped with the necessary tools and documents to carry out the audit?

Step 4: Communicate the Audit Plan

Clear communication is vital to ensure all stakeholders are informed about the audit. This step includes notifying employees and management about the audit schedule, scope, and objectives.

Example Questions:

• Has the audit plan been shared with top management and key departments?

• Are all employees involved in the audit aware of their roles and responsibilities?

• Have the audit dates and timeframes been confirmed with all parties?

• Is the audit schedule aligned with the organization’s operational hours?

• Have all potential conflicts with normal operations been resolved?

Step 5: Prepare for Audit Execution

The final preparation step involves gathering materials and resources for the audit. This includes creating checklists, forms, and review criteria.

Example Questions:

• Have the necessary tools, checklists, and forms been prepared for the audit?

• Is there a system in place to track findings and non-conformities during the audit?

• Are all necessary resources, such as IT systems and documents, available for the audit team?

• Have all the audit criteria been established, and are they aligned with ISO 9001 standards?

• Is there a plan for reporting audit results and corrective actions?

Step 6: Execute the Audit

Executing the audit involves actual data collection, interviews, and observation of processes. The audit team needs to adhere to the planned schedule while remaining flexible to follow up on any unexpected findings.

Example Questions:

• Are the auditors following the established audit plan and schedule?

• Are the processes being audited clearly documented and understood by those responsible?

• Is the audit team documenting findings accurately and in real time?

• Are any immediate corrective actions being taken for non-conformities identified during the audit?

• Are all relevant employees cooperating and providing the necessary information during the audit?

By following this checklist, you are ready for an ISO 9001 internal audit. However, there is no denying that businesses face challenges in implementing the checklist. What are those, and how can you overcome them?

Challenges in Implementing the ISO 9001 Internal Audit Checklist and Software Solutions 

Implementing an ISO 9001 internal audit checklist can present several challenges, especially in terms of managing documentation, tracking actions, and coordinating teams. However, software solutions like BPR Hub, Greenlight Guru, MasterControl, and AuditHub can significantly smooth the process and reduce the burden on your team. Let’s explore some common challenges and how these tools provide effective solutions.

1. Managing Audit Data and Documentation

Keeping track of audit documentation, findings, and historical records is a significant challenge. Without an organized system, it’s easy for audit data to become fragmented or lost.

How Software Solutions Help:
Platforms like Greenlight Guru and AuditHub provide centralized, cloud-based document management systems. These tools organize and store all relevant audit records, audit trails, and findings in one place, making them easy to access and review. You can also quickly reference past audits and corrective actions, saving time and ensuring that everything is up-to-date and compliant.

2. Tracking Non-Conformities and Corrective Actions

A key challenge in ISO 9001 audits is addressing non-conformities and tracking corrective actions. Without proper systems in place, this process can become tedious and lead to delayed resolutions.

How Software Solutions Help:
Solutions like BPR Hub and MasterControl offer automated workflows that help you track non-conformities promptly. These platforms help assign tasks, set deadlines, and receive automated reminders so nothing is overlooked. The ability to track the status of corrective actions in real time also enhances accountability.

3. Coordinating Audit Schedules and Resource Allocation

Coordinating audit schedules and managing resources effectively is a challenge, especially when dealing with multiple departments and auditors.

How Software Solutions Help:
With BPR Hub and AuditHub, you can create and manage audit schedules, assign auditors, and ensure that the necessary resources are allocated. These platforms provide visibility into who is responsible for what, reducing scheduling conflicts and making it easier to plan audits efficiently.

4. Maintaining Continuous Improvement

One of the important goals of ISO 9001 audits is to drive continuous improvement. Without the right tools, it can be difficult to track improvements and ensure they are implemented across the organization.

How Software Solutions Help:
Tools like BPR Hub and AuditHub help you continuously monitor the performance of your QMS and track improvements over time. These systems allow for easy identification of trends and areas of improvement, enabling you to take action before small issues become larger problems.

Wrapping Up: The Role of BPR Hub in ISO 9001 Internal Audits

With the right software tools, like BPR Hub’s Audit Hub, preparing for ISO 9001 audits becomes much more efficient and effective. From managing compliance to tracking audit efficiency, this platform brings user-friendliness at an affordable price. 

You can directly Mail BPR Hub at hello@bprhub.com and book a free demo to understand better.

Frequently Asked Questions

1. What is the difference between an internal audit and an external audit?

An internal audit is conducted by the organization itself, typically by trained employees, to assess compliance with ISO 9001 and internal processes. An external audit is conducted by an independent third-party auditor to verify compliance with ISO 9001 standards for certification or recertification.

2. How often should internal audits be conducted for ISO 9001?

ISO 9001 requires that internal audits be conducted at planned intervals. The frequency depends on factors like the size of the organization, the complexity of the processes, and the results of previous audits. Typically, audits are performed annually, but more frequent audits may be needed based on organizational needs or risks.

3. What should be included in an ISO 9001 internal audit report?

An ISO 9001 internal audit report should include an overview of the audit process, the areas audited, identified non-conformities, corrective actions taken, and recommendations for improvement. The report should also document any areas of compliance or concern that need follow-up.

4. How do you ensure the effectiveness of an ISO 9001 internal audit?

To ensure the effectiveness of an internal audit, auditors must be adequately trained and independent. Regular audits should be conducted, audit findings should be tracked, and corrective actions should be implemented promptly. Using audit software, like BPR Hub or AuditHub, can help maintain a structured, comprehensive approach to tracking audit results and implementing corrective actions.

5. What happens if an organization fails an ISO 9001 audit?

If an organization fails an ISO 9001 audit, it will need to address the identified non-conformities by taking corrective actions. The organization may be given a certain period to fix the issues. Failing to address these issues may result in delayed certification or loss of certification.