ISO 9001:2015 is an international standard outlining the requirements for a quality management system. It is designed to help organisations improve their processes and customer satisfaction. An ISO 9001:2015 audit is a review of an organisation’s quality management system to ensure it meets the requirements of the standard. 

Here, our ISO accreditation consultants share the seven most crucial audit questions that organisations should be prepared to answer:

1. How Does the Organization Determine Its Context?

The first question an auditor will likely ask is how an organisation determines its context. Context refers to the internal and external factors that affect an organisation’s ability to achieve its objectives. The ISO 9001:2015 standard requires organisations to understand their context to ensure their quality management system is effective. Organisations must identify their stakeholders, their needs and expectations, and the internal and external factors that affect their ability to meet those needs.

2. How Does the Organization Determine Its Risks and Opportunities?

The ISO 9001:2015 standard requires organisations to identify and address risks and opportunities that could affect their ability to achieve their objectives. An auditor will want to know how an organisation determines its risks and opportunities, how it assesses them, and how it prioritises them. Organisations must have a process to identify and manage risks and opportunities, which must be documented.

3. How Does the Organization Ensure That It Meets Customer Requirements?

The ISO 9001:2015 standard requires organisations to meet customer requirements and enhance customer satisfaction. An auditor will want to know how an organisation determines customer requirements, how it ensures it meets those requirements, and how it measures customer satisfaction. Organisations must have a process in place to monitor customer satisfaction, and they must have a process to address customer complaints.

4. How Does the Organization Ensure the Competence of Its Personnel?

The ISO 9001:2015 standard requires organisations to ensure the competence of their personnel. An auditor will want to know how an organisation determines the competence of its personnel, how it ensures they have the necessary skills and knowledge, and how it measures their competence. Organisations must have a process in place to identify training needs, to provide training, and to assess the effectiveness of the training.

5. How Does the Organization Manage Its Processes?

The ISO 9001:2015 standard requires organisations to manage their processes effectively. An auditor will want to know how an organisation identifies its processes, how it documents them, how it monitors them, and how it measures their effectiveness. Organisations must have a process in place to monitor and measure their processes, and they must have a strategy to address any non-conformities.

6. How Does the Organization Manage Its Suppliers?

The ISO 9001:2015 standard requires organisations to manage their suppliers effectively. An auditor will want to know how an organisation selects its suppliers, how it assesses its performance, and how it addresses any non-conformities. Organisations must have a process in place to monitor and measure supplier performance, and they must have a process to address any non-conformities.

7. How Does the Organization Ensure Continual Improvement?

The ISO 9001:2015 standard requires organisations to improve their quality management system continually. An auditor will want to know how an organisation identifies opportunities for improvement, how it implements changes, and how it measures the effectiveness of those changes. Organisations must have a process in place to identify and implement improvements, and they must have a process in place to monitor and measure the effectiveness of those improvements.

Conclusion

Preparing for an ISO 9001:2015 audit can be a daunting task. Still, it is essential for organisations that want to improve their quality management system and get an ISO 9001 certification in Australia. The seven most important audit questions outlined in this article provide a starting point for organisations to prepare for an audit. By addressing these questions, organisations can ensure they are meeting the requirements of the standard and continually improving their processes.

The ISO Council is a specialised consulting company based in Australia, composed of a group of consultants with extensive experience in various industry sectors. Our services cover the entire ISO certification process, focusing on the creation, execution, and upkeep of ISO 9001, ISO 14001, ISO 45001, ISO 27001, and other relevant industry standards. Contact us to learn how we can help you with your ISO 9001 certification in Australia!