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Developing an Effective ISO 9001 Internal Audit Checklist: Key Considerations

02/06/2023by admin0Read: 9 minutes

Are you tired of conducting the same old internal audits for ISO 9001 Internal Audit Checklist, only to find that they are not yielding the desired results? Are you looking for a way to revolutionise your approach to internal auditing, and ensure that your organisation is always compliant with ISO 9001 standards? Look no further! In this article, we will explore the top checklist questions that will help you to conduct a more effective, efficient, and insightful ISO 9001 Internal Audit Checklist. These questions have been carefully crafted by experts in the field and are designed to cover all the critical areas of the standard.

By incorporating these questions into your ISO 9001 Internal Audit Plan, you can rest assured that your organisation is always on track toward ISO 9001 compliance and that you are providing the best possible value to your clients and stakeholders. So, let’s get started and revolutionise your ISO 9001 internal audit today!

Overview of ISO 9001 Internal Audit

ISO 9001 is a quality management system that outlines the requirements necessary for an organisation to consistently provide products and services that meet customer and regulatory requirements. As part of this system, internal audits are essential to ensure compliance and identify areas for improvement.

The internal audit process within ISO 9001 involves a systematic review and evaluation of the organisation’s quality management system. This process is performed by trained auditors who are not part of the area being audited. The auditors examine the organisation’s policies, procedures, and records to determine whether they are compliant with ISO 9001 standards.

Checklist questions aid auditors in assessing compliance and identifying areas for improvement by providing a standardised set of questions that are relevant to the organisation’s quality management system. These questions cover all aspects of the system, including management responsibility, resource management, product realisation, measurement, and analysis. By answering these questions, auditors can assess the organisation’s level of compliance and identify areas where improvements can be made.

For example, if an auditor is reviewing a company’s measurement and analysis process, they may use a checklist question such as “Have you established procedures to monitor and measure customer satisfaction?” If the organisation cannot provide evidence of such a procedure, the auditor can identify this as an area for improvement.

So, the use of checklist questions can aid auditors in their assessment and provide a standardised approach to the audit process.

 

Developing an Effective Internal Audit Checklist

Developing an effective internal audit checklist is a critical component of maintaining a quality management system that is compliant with ISO 9001 requirements.

Some key considerations for developing an effective internal audit checklist include:

  1. Understanding ISO 9001 requirements:

    The first step in developing an effective internal audit checklist is to understand the requirements outlined in ISO 9001. This includes understanding the key principles, clauses, and sub-clauses of the standard. This understanding will help in developing an audit checklist that is comprehensive and aligned with the standard.

  2. Tailoring the checklist to the organisation’s specific context:

    While it is necessary to understand ISO 9001 requirements, it is also essential to tailor the audit checklist to the organisation’s specific context. This includes considering the organisation’s size, complexity, and industry. Organisations in different industries may have varying requirements, and the audit checklist should reflect these specific needs.

  3. Incorporating relevant process areas, activities, and controls:

    An effective internal audit checklist should include all relevant process areas, activities, and controls. The checklist should cover all areas of the organisation that are critical to the quality management system. This includes areas such as procurement, production, testing, and inspection.

  4. Ensuring clarity and specificity in the questions:

    The questions in the checklist should be clear and specific to ensure that auditors can understand them easily. Vague or ambiguous questions can lead to inaccurate or incomplete audit results.

Hence, an effective audit checklist is a critical component of maintaining a robust quality management system and ensuring compliance with the ISO 9001 standard.

Internal Audit Checklist Structure

Auditors use an internal audit checklist as a tool to assess the effectiveness of an organisation’s internal controls and processes. This structured approach helps auditors ensure that they review all aspects of the organisation’s operations.The structure of the internal audit checklist typically consists of the following sections:

Section 1: General Information and Scope – This section provides an overview of the audit process, including the objectives, scope, and methodology. It also includes information about the auditors and the organisation being audited.

Section 2: Leadership and Management Commitment – This section assesses the commitment of the organisation’s leaders and management to the implementation and maintenance of internal controls. This includes areas such as governance, ethics, and culture.

Section 3: Planning and Risk Management – This section evaluates the organisation’s ability to identify, assess, and manage risks. It includes areas such as strategic planning, risk assessment, and risk management processes.

Section 4: Resource Management – This section reviews the organisation’s management of resources, including human resources, financial resources, and physical resources. It looks at areas such as budgeting, staffing, and asset management.

Section 5: Process Management – This section examines how the organisation manages its processes. It includes areas such as process documentation, process improvement, and internal controls.

Section 6: Performance Evaluation – This section assesses how the organisation measures and evaluates its performance, including the use of key performance indicators (KPIs) and metrics.

Section 7: Improvement and Corrective Actions – This section assesses the organization’s approach to continuous improvement, including how it identifies and addresses areas for improvement. It may include questions related to how it tracks and monitors corrective actions.

Sample Internal Audit Checklist Questions

The process monitoring and measurement section of an internal audit checklist typically focuses on assessing how well an organisation is monitoring and measuring its processes to ensure that they are efficient, effective, and meeting the desired outcomes. Here are some sample questions for this section, along with key areas to be assessed:

Documentation and Record Keeping:
  • How do you ensure that your documents and records are up-to-date and accurate?
  • How do you control the distribution and access to your documents and records?
  • How do you ensure that you properly identify, review, and approve your documents and records?
Leadership Involvement and Commitment:
  • How does top management demonstrate their commitment to quality management?
  • How does top management communicate the importance of quality management to the rest of the organisation?
  • How does the top management establish and review quality objectives?
Risk Identification and Mitigation:
  • How do you identify and assess risks associated with your products, services, and processes?
  • How do you prioritise, and address identified risks?
  • How do you continuously monitor and review your risk management processes?
Competence and Training of Personnel:
  • How do you determine the competency requirements for your personnel?
  • How do you train and qualify your personnel for their roles and responsibilities?
  • How do you evaluate the effectiveness of your training programs?
Process Monitoring and Measurement:
  • Are key process indicators (KPIs) established and monitored regularly?
  • Are there any trends or patterns in the data that suggest a need for process improvement?
  • Do companies adequately train their employees on how to monitor and measure their respective processes?
  • Do you take corrective actions when process performance falls below acceptable levels?
Customer satisfaction and feedback:
  • How does the organisation measure customer satisfaction? Are there formal surveys or feedback mechanisms in place?
  • How are customer complaints and feedback addressed, and what processes are in place to ensure that issues are resolved in a timely and effective manner?
  • Are there metrics in place to track customer satisfaction levels over time, and are these metrics being analysed and acted upon?
Corrective and preventive actions:
  • Are there processes in place to identify and address process inefficiencies or failures?
  • How are corrective and preventive actions identified and tracked?
  • Is the team tracking the effectiveness of corrective and preventive actions through metrics and analyzing and taking action upon them?

These sample questions cover various aspects of the ISO 9001 standard and can help organisations assess their compliance and identify areas for improvement.

How the checklist questions should be used during the internal audit process

You can use the Internal Audit Checklist as a valuable tool to ensure that you cover all necessary areas during the internal audit process and conduct a thorough audit. Use the checklist questions during the different stages of the internal audit to achieve this.

  1. Conducting interviews & observations:

    During the audit, the auditor should interview key personnel to understand the processes being audited. The auditor should use the checklist to ask all relevant questions during the interview and make observations to ensure that the documented processes are being followed.

  2. Reviewing documentation & records:

    The auditor should review relevant documentation and records to ensure that they meet the requirements of the ISO 9001 standard. You can use the checklist to verify that all necessary documents and records are present and meet the requirements of the standard.

  3. Assessing compliance with ISO 9001 requirements:

    The auditor should use the checklist questions to assess compliance with the requirements of the ISO 9001 standard. Each question should be reviewed to ensure that the relevant requirement is being met.

  4. Identifying nonconformities & areas to improve:

    Use the checklist to identify any nonconformities or areas that need improvement. Note any unmet requirement on the checklist and include it in the audit report. Additionally, the auditor should use the checklist to identify areas that could benefit from improvement, even if they are not currently nonconforming.

By using the checklist effectively, the auditor can ensure that the organisation’s QMS meets the requirements of the ISO 9001 standard and identify opportunities for improvement.

Adapting the Checklist to Organisational Needs

Customising the checklist to fit the specific requirements and processes of the organisation is crucial for ensuring effective implementation of quality management systems. Every organisation has its unique set of operational procedures and workflows, which means that a one-size-fits-all approach may not work for them.

Tailoring a customized checklist to the organization’s specific needs makes it easier to identify critical areas that require attention and ensures that the quality management system meets all its requirements.

For example, a manufacturing company with a highly automated production process may require more stringent monitoring of their equipment and machinery. Therefore, they would need to include specific checks in their checklist to ensure that all the equipment is functioning correctly and they can detect any defects early.

It is also essential to note that quality management systems are continually evolving, and organisations need to update their checklists regularly to reflect changes in their processes. Regular updates help to ensure that the organisation remains compliant with regulations and standards.

Ready-to-use ISO 9001 Checklist

Here is a general ISO 9001 Checklist to help organisations check the readiness of their management system to get certified:

1) Context

a) Organisation

  • Have you identified internal and external factors impacting the quality system?

Interested Parties

  • Have relevant internal and external stakeholders and their requirements been identified?

c) Scope

  • Is the scope of the quality system clearly defined and documented?

d) Leadership

2) Leadership & Commitment

  • Can top management demonstrate leadership and commitment to the quality system?

a) Customer Focus

  • Is customer focus maintained by understanding and meeting requirements to ensure customer satisfaction?

b) Quality Policy

  • Is the documented quality policy communicated and accessible?

c) Roles & Responsibilities

  • Are roles and responsibilities for quality effectively communicated?
  • Planning

Risk & Opportunities

  • Have quality-related risks and opportunities been identified, addressed, and documented?

a) Scope (Again)

  • Is the scope of the quality system well-defined and documented?

b) Quality Objectives

  • Have quality objectives been established, monitored, measured, communicated, and recorded?

c) Change

  • Are changes to the quality system planned and controlled?

4) Support

Resources

  • Are necessary resources in place for the quality system, including personnel, infrastructure, and the work environment?

b) Organisational Knowledge

  • Is organisational knowledge retained and shared effectively?

c) Awareness

  • Are personnel aware of the policy, relevant objectives, and their responsibilities?

d) Control of Documents

  • Are documents and records effectively controlled?

e) Measurement

  • Is measuring equipment calibrated, and are records maintained?

f) Competence

  • Is personnel competence ensured and recorded?

g) Communication

  • Are processes for internal and external communication relevant to quality determined?

5) Operations

a) Operational Planning and Control

  • Are procedures established and maintained to meet quality system requirements?

b) Design & Development

  • Are design processes controlled, including inputs, outputs, changes, verification, and reviews?

c) Product & Service Provision

  • Is production and service provision undertaken in a controlled way, with documentation available?

d) Customer & External Supplier Property

  • Is customer and external supplier property safeguarded, and are records maintained?

e) Post Delivery

  • Are processes in place for post-delivery requirements, including contractual obligations and maintenance?

f) Release of Products & Services

  • Are products and services released to customers in a controlled manner, with records demonstrating conformity?

g) Requirements for Products & Services

  • Are customer, statutory, and regulatory requirements for products and services determined and recorded?

h) External Providers

  • Are processes established for the selection, evaluation, and monitoring of suppliers and contractors, with effective communication?

i) Identification & Traceability

  • Are outputs identifiable, and are traceability records maintained?

j) Preservation

  • Are processes in place to manage preservation during production, including controls for packaging, handling, storage, and transportation?

k) Control of Changes

  • Are changes to production or service provision reviewed and controlled, with records maintained?

l) Non-Conforming Outputs

  • Are non-conforming outputs controlled to prevent release, with records maintained?

6) Performance Evaluation

a) Monitoring & Measurement

  • Are processes, operational controls, and equipment requiring maintenance or calibration monitored, measured, analysed, evaluated, and recorded?

b) Management Review

  • Does top management review the quality system at planned intervals, with records maintained?

c) Customer Satisfaction

  • Is customer perception assessed, monitored, and reviewed?

d) Internal Audit

  • Are internal audits planned and conducted to ensure conformity and effective implementation of the quality system, with records maintained?

7) Improvement

a) Non-Conformity & Corrective Action

  • Are processes in place for reporting, investigating, and taking action on incidents and corrective actions, with records maintained?

b) Continual Improvement

  • Is the quality system continually improved?

For a tailored ISO 9001 Checklist for your business, feel free to contact our team at 1300 802 163 or e-mail – sales@anitechgroup.com.

Conclusion

In conclusion, the ISO 9001 internal audit checklist is a valuable tool for organisations to assess the effectiveness of their Quality Management Systems. By providing a structured approach and standardised set of questions, the checklist ensures thorough and consistent assessments of compliance with ISO 9001 requirements. It aids auditors in identifying areas for improvement, promoting continuous quality improvement.

Customising the checklist to organisational needs enhances its effectiveness, allowing organisations to address specific processes and workflows.

Overall, the internal audit checklist plays a crucial role in maintaining a robust QMS and delivering high-quality products and services.

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