ISO 9001 Audits: What to Expect and How to Prepare

ISO 9001 is an internationally recognised standard that outlines the requirements for a quality management system (QMS). If your organisation is seeking ISO 9001 certification, you will need to undergo an audit to ensure compliance with the standard. This can be a daunting prospect, but with proper preparation, the audit can be a valuable learning experience that helps improve your organisation’s quality management system. In this article, we will explore what to expect during an ISO 9001 audit and provide tips on how to prepare for a successful outcome.

What is an ISO 9001 Audit?

An ISO 9001 audit is an evaluation of an organisation’s QMS to determine if it meets the ISO 9001 standard. The audit is conducted by an independent third-party auditor who reviews the organisation’s QMS documentation, processes, and procedures to ensure they meet the requirements of the ISO 9001 standard. The audit can be conducted internally or externally, depending on the organisation’s preference.

There are two types of ISO 9001 audits: a surveillance audit and a re-certification audit. A surveillance audit is conducted annually to ensure that the organisation’s QMS continues to meet the ISO 9001 standard. A re-certification audit is conducted every three years to determine if the organisation’s QMS still meets the ISO 9001 standard.

How to be Prepared for an ISO 9001 Audit?

To be prepared for an ISO 9001 audit, an organisation should follow these steps:

1. Understand the ISO 9001 Standard

The first step in preparing for an ISO 9001 audit is to understand the ISO 9001 audit requirements. This can be done by reviewing the standard and understanding its sections, clauses, and requirements. The organisation should also ensure that all employees are aware of the standard and its requirements.

2. Conduct an Internal Audit

Before the external audit, the organisation should create an internal audit checklist to identify any non-conformances and address them before the external audit. The internal audit should be conducted using the ISO 9001 standard as a reference and should involve employees from different departments.

3. Develop a QMS Documentation

The QMS documentation should include policies, procedures, work instructions, and forms that outline the organisation’s processes and procedures. The documentation should be reviewed and updated regularly to ensure it remains relevant and up to date.

4. Train Employees

All employees should be trained on the ISO 9001 standard and the organisation’s QMS. This will ensure that everyone understands their roles and responsibilities in implementing the QMS and meeting the ISO 9001 standard.

5. Conduct a Management Review

The organisation’s management should conduct a review of the QMS to ensure it is effective and efficient. The review should include an assessment of the organisation’s processes, procedures, and objectives.

6. Prepare for the External Audit

The organisation should prepare for the external audit by ensuring all documentation is up to date, all employees are aware of the audit, and any non-conformances identified during the internal audit have been addressed.

Conclusion

An ISO 9001 audit is an assessment of an organisation’s QMS to determine if it meets the ISO 9001 standard. To be prepared for an ISO 9001 audit, an organisation should understand the standard, conduct an internal audit, develop QMS documentation, train employees, conduct a management review, and prepare for the external audit. By following these steps, an organisation can ensure its QMS meets the ISO 9001 standard and is effective and efficient.

If you want to become ISO certified, you’ll need help from a qualified ISO consultant or auditor who can guide you through the process and ensure that you meet all the requirements of the standard. This is where ISO 9001 Consultants comes into play. We are the leading ISO standards consultant in Australia, providing expert guidance and support to organisations looking to achieve ISO certification. Contact us today to learn more about how we can help you with your 9001 ISO certification in Sydney.