ISO 9001 Audit Survival Guide: How to Ace Your Next Audit – Part 2
As we mentioned in Part 1 of this series, an ISO 9001 audit can be a daunting...
ISO 9001 is a widely recognised standard for quality management systems that sets out the requirements for organisations to achieve customer satisfaction and continuous improvement. To maintain compliance with this standard, organisations must undergo regular audits to validate their adherence to the requirements. The audit process can be challenging, but understanding the steps involved can help organisations prepare and ensure a successful outcome.
In this multi-part series. we’ll take a deep dive into how you can survive an ISO 9001 audit, starting with a breakdown of its process. By following these tips, you’ll be well-equipped to navigate the audit process and ensure a successful outcome.
The audit process begins with the planning phase, where the audit team determines the scope, objectives, and criteria for the audit. The audit team will also identify key stakeholders and plan the logistics of the audit, such as dates and times and necessary documentation. During this phase, the organisation being audited will also be notified of the audit and provided with an overview of the audit process.
The next phase of the audit process involves a review of the organisation’s documentation, including policies, procedures, work instructions, and records. The audit team will assess whether the documentation meets the requirements of the ISO 9001 standard and whether it accurately reflects the organisation’s processes.
The on-site audit is the most critical phase of the audit process. The audit team will visit the organisation’s facilities and observe the processes in action. They will interview employees, review records, and assess the effectiveness of the organisation’s quality management system. The audit team will also identify any non-conformances or areas of improvement that need to be addressed.
After the on-site audit is complete, the audit team will compile an audit report. The report will include a summary of the audit findings, including any non-conformances found, as well as recommendations for improvement. The organisation will have an opportunity to review the report and provide feedback before it is finalised.
If non-conformances are identified during the audit, the organisation must take corrective action to address them. This may involve updating policies or procedures, improving training programs, or implementing new processes or controls. The corrective action must be documented and communicated to all relevant stakeholders.
After the corrective action has been taken, the organisation will undergo a follow-up audit to ensure that the non-conformances have been addressed. The follow-up audit may be conducted on-site or remotely, depending on the severity of the non-conformance. If the follow-up audit is successful, the organisation will be deemed in compliance with the ISO 9001 standard.
Maintaining compliance with the ISO 9001 standard can be a challenging but rewarding process. By following the steps outlined above, organisations can ensure that they are adequately prepared for the audit process and can achieve continuous improvement in their quality management systems.
The ISO 9001 audit process can be challenging, but it is a crucial step in maintaining compliance with the standard and achieving continuous improvement in quality management systems. By understanding the steps involved in the audit process, organisations can adequately prepare and ensure a successful outcome. The benefits of compliance with the ISO 9001 standard are significant, including improved customer satisfaction, increased operational efficiency, and enhanced competitive advantage.
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