An internal audit plan is instrumental in successfully implementing a quality management system (QMS) for businesses. It is essential in driving continual improvement and ensuring compliance with industry standards.
A QMS helps ensure that products and services meet customer requirements, allowing businesses to continually improve their operations, thus leading to their success.
One of the critical components of QMS is the internal audit plan, which is pivotal to the overall growth of an organisation.
This blog discusses the importance of an internal audit plan for an organisation’s QMS, its key components, and how to create and implement an effective internal audit plan.
What is an Internal Audit Plan?
An internal audit plan systematically and independently evaluates a company’s quality management system. It aims to identify areas of non-compliance and potential areas of improvement within the QMS to help businesses overcome these shortcomings.
Importance of Internal Audit for a Quality Management System
Internal audits are beneficial for identifying potential gaps and weaknesses within a quality management system (QMS), ensuring it aligns with organisational objectives and comply with regulatory requirements such as the ISO 9001 Standard.
Furthermore, internal audits facilitate communication between staff, management, and other stakeholders, promoting accountability and transparent decision-making.
Benefits of Internal Audit for QMS
Some benefits of QMS internal audit are as given below:
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Ensuring Compliance:
Internal audits help organisations comply with relevant standards, regulations, and customer requirements. By identifying areas of non-compliance, companies can take corrective action to maintain certifications, avoid fines or other penalties, and meet customer expectations.
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Identifying Process Gaps:
Internal audits identify inefficiencies in existing processes, providing opportunities for improvement. Addressing these gaps can increase productivity, streamline operations, and overall cost savings.
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Evaluating Risks:
Internal audits serve as a risk management tool by assessing the organisation’s risk landscape and determining potential vulnerabilities. By pinpointing areas of high risk, businesses can implement appropriate mitigation measures to minimise negative consequences.
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Enhancing Continuous Improvement:
Internal audits foster a culture of continuous improvement by promoting open communication and collaboration across departments. It supports an environment where employees are encouraged to identify areas or inefficiencies that can be improved.
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Building Stakeholder Confidence:
Regular internal audits bolster stakeholder confidence by demonstrating the organisation’s commitment to quality and improvement. Organisations can achieve long-term growth goals with increased trust from investors, customers, and employees.
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Knowledge Transfer:
Internal audits facilitate sharing of best practices among departments or different company locations. This knowledge exchange enables employees to learn from one another’s strengths and challenges to improve their processes collectively.
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Monitoring Performance Metrics:
By tracking key performance indicators (KPIs) over time, internal audits provide valuable insights into an organisation’s progress towards its quality objectives.
Key Requirements to Conduct an Internal Audit
The following key requirements are crucial in conducting an internal audit:
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Qualified Auditors and Quality Management Consultant:
Ensure auditors possess the necessary knowledge to understand business processes and meet relevant auditing standards.
Involving a quality management consultant can be beneficial in conducting an internal audit. They can provide valuable insights into your quality management system and help you identify potential areas of improvement. A quality management consultant can also ensure that your audit complies with the ISO 9001 standard and provide guidance on implementing corrective actions.
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Risk-Based Approach:
Prioritise areas of high risk within the organisation for efficient resource allocation.
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Employee Participation:
Employee and staff contribution is critical in internal audits. They can provide valuable insights into the effectiveness and efficiency of your quality management system and help you identify potential areas of improvement.
Involve employees in the planning and conducting process to promote ownership of their respective roles. Employee and staff involvement also helps create a quality culture within your business and encourages participation in the quality management system.
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Top Management Commitment:
Encourage senior leadership to actively participate in internal audits to demonstrate their support for continual improvement.
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Documentation
Maintaining well-organised documentation facilitates the audit process by comprehensively understanding the QMS processes in place. This includes process maps, key performance indicators (KPIs), work instructions, records associated with corrective actions taken or root cause analysis reports.
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Knowledge of QMS Standards:
The consultant or internal auditor should understand the relevant QMS standards like ISO 9001, ISO 13485, or other applicable industry-specific standards.
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Knowledge of QMS Documentation:
The internal auditor or consultant should understand the QMS documentation, including policies, procedures, work instructions, and forms, to ensure that the audit scope is appropriate and covers all relevant areas.
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Identification of Relevant Processes:
They should identify the relevant QMS processes to audit. This includes determining the critical processes that need to be audited to ensure compliance with QMS standards and non-critical processes that may need improvement.
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Use of Audit Checklist:
The professionals should use an audit checklist to ensure that all relevant areas are covered during the audit. The checklist should be based on the QMS standards and the organisation’s QMS documentation.
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Gathering Evidence:
The internal auditor or QMS consultant should gather evidence to support their findings during the audit. This includes reviewing documentation, interviewing staff, and observing processes.
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Reporting Findings:
The internal auditor or consultant should report their findings clearly and concisely. It includes identifying non-conformities or areas for improvement, providing evidence to support their findings, and recommending corrective action.
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Follow-up and Verification:
The consultant or internal auditor should follow up to check if corrective action has been taken to address any non-conformities identified during the audit. The effectiveness of corrective action should also be verified to ensure that the quality management system continues to meet the organisation’s requirements.
Step-by-Step Internal Audit Plan
A well-structured internal audit plan is fundamental in managing risks, driving continual improvement, and achieving business success. The audit plan should outline the audit scope, objectives, frequency, resources needed, reporting guidelines, and an appropriate methodology for evaluating processes.
To create an Internal Audit Plan for a quality management system for Australian businesses, follow these steps:
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Define Scope:
Identify the key processes, departments, and activities to be audited, considering the requirements of the ISO 9001 standard and any applicable local regulations.
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Prioritise Risks:
Conduct a risk assessment to identify the highest risk areas within your organisation. This will help you focus your audit efforts on the areas posing the greatest impact on your business’s overall quality management system.
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Develop Audit Schedule:
Create a schedule that outlines regular and ad-hoc audits throughout the year. The audit frequency should reflect the prioritisation of risks identified in Step 2, with higher-risk areas being audited more often.
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Assign Audit teams:
Create small, cross-departmental teams of auditors with relevant expertise in the assessed areas. Ensure team members are well-versed in applicable Australian regulations and ISO 9001 requirements.
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Plan Individual Audits:
Identify objectives, scope, criteria, and assessment methods for each specific audit. Develop checklists and testing procedures tailored to your business and industry-specific requirements.
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Communicate with Stakeholders:
Notify relevant personnel about upcoming audits well in advance. Provide clear expectations for their role and availability during this process.
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Conduct Audit:
Follow your prepared plan for each specific audit, using established checklists and testing procedures to collect data.
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Document Findings:
Thoroughly record all audit findings, including non-conformities, observations, and opportunities for improvement.
Proper documentation is essential in supporting audit findings and recommendations. Maintaining detailed records during the audit—including data collection sheets, corrective action reports, and summaries—makes it easier for organisations to resolve issues efficiently.
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Document Important Dates
Document the date of commencing and ending an internal audit. Additionally, record dates when the software or any procedure was updated.
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Conduct Follow-up Activities:
Implement any necessary corrective actions based on findings from the audit process. Monitor progress regularly to ensure effectiveness and verify the resolution of identified issues.
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Track actions in due Time
Organisations should track actions in due time and evaluate all modules to take corrective measures.
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Improvement action plan
Create an Improvement action plan to sustain continual compliance with the latest rules and regulations. You can take help from experienced consultants.
By following this outline, you can create a comprehensive Internal Audit Plan for your quality management system in accordance with Australian regulations and the ISO 9001 standard.
Remember to keep your plan up-to-date and reassess risks regularly to ensure it continually mirrors your business objectives and any changes in regulatory requirements.
Things to Remember
- Implementing a risk-based approach to audits ensures that priority is given to high-risk areas.
- Communicating the purpose and benefits of the audit to all relevant parties increases their buy-in and support.
How can Anitech’s Quality Management Consultants help?
Anitech’s Quality Management Consultants can help in an internal audit by:
- Examining the organisation’s quality management system (QMS) to ensure its effectiveness and compliance with relevant standards.
- Identifying gaps, non-conformities, and areas for improvement in the QMS.
- Providing recommendations on how to address these issues and improve the QMS.
- Assisting in the preparation and implementation of corrective and preventive actions.
- Verifying that the implemented changes have effectively addressed the identified issues.
- Training staff on best practices and ensuring that they are competent in their roles related to quality management.
- Providing guidance on maintaining records and documentation required for internal audits.
- Ensuring the internal audit process is objective, consistent, and structured.
- Evaluating the level of risk associated with identified issues to prioritise remediation efforts.
- Helping to maintain a culture of continuous improvement within the organisation by identifying opportunities for streamlining processes and enhancing efficiency.
If you want Anitech’s experienced QMS consultants to help you create and implement an internal audit plan, call us at 1300 802 163 or email us at info@anitechgroup.com
Our team will be happy to help you!
