ISO 9001 certification is a strategic process where the parties involved must fulfill various requirements. ISO 9001 is a certification of an organization’s quality management systems (QMS). It applies to businesses of all sizes and industries. The entire certification workflow is a systematic procedure to determine if the organization’s QMS actively meets the quality objectives by reviewing and documenting all procedures, processes, and systems associated with product quality.
Audits are crucial to the ISO 9001 certification process. Organizations can conduct internal audits based on the audit plan across the departments/functions. They may take appropriate actions for the closure of the non-conformances raised during the internal audits. However, the first stage of the certification audit is the external audit. The Certification Body (CB or Registrar) verifies an organization’s readiness towards the final certification audit. They verify the QMS documentation and organizational structure to ensure that it aligns with ISO 9001. They communicate the potential issues through the first stage audit report that may hinder an organization’s final certification.
The final certification audit then takes place and is based on results, and the certification body recommends the ISO 9001 certification of the organization. You can refer to Aegis ISO certification audit service to handle the audit for your organization. You can outsource consultants to perform a gap analysis of your QMS and carry out an ISO 9001:2015 need analysis of the various processes. Addressing the identified gaps may require organizations to add new personnel, procedures, documents, and new quality controls. They should consider implementing Plan Do Check Act (PDCA) cycle to effectively fill these gaps, reduce errors, mitigate risks, and improve the current state to reach the desired goal.
Here are a few tips for a successful ISO 9001:2015 certification audit.
Stakeholders must prepare proactively and align the QMS towards the audit-ready stage. Thus, organizations must keep their systems and processes optimized to prepare for audits thoroughly. Internal audit is an efficient way to prepare for a customer or regulatory inspection. It prepares an organization for an external audit. Internal audits must be formal, impartial, objective, and organized. The internal audit team must inspect its processes and policies to ensure that it complies with those documented within the QMS.
Moreover, in the preparation stage, the process manager must get the staff ready for the audit workflow and train them appropriately to conduct themselves. They may prepare subject matter experts (SMEs) to interact with the auditor efficiently. The stakeholders must also review the documents for completeness and accuracy.
Be Transparent with Documentation
The QMS documentation provides a clear framework of the operations within the organization. The documentation processes must effectively define how you will complete reviews, approvals, and reapprovals. Ensure that the documentation is up-to-date, and keep it ready per the ISO 9001 guidelines.
Maintain an Audit Mindset
Organizations must actively incorporate the suggestions of auditors to eliminate the deficiencies in controls and cases of non-compliance with policies and procedures. The stakeholders must not consider the audit process an interrogation, but it is, in effect, a conversation. It can help you identify the loopholes and continually improve. It helps drive the improvement of both processes and products. Thus, when preparing for a certification audit, maintaining a positive outlook towards the audit process can help boost integrity and confidence in the QMS.
Employ Risk-Based Thinking
Risk-based thinking is a systematic approach to risk management. Organizations must incorporate it throughout the entirety of their QMS. Risk-based thinking helps identify, consider, and control risks throughout the design and use of QMS. The more risks you identify and document before the certification audit takes, the better you are prepared for the inspection. It will help them prioritize and focus on essential risks and apply preventive measures to mitigate them. Risk-based thinking under ISO 9001 helps organizations develop a culture of continual improvement and achieve greater consistency of quality of goods and services. You must consider risks both quantitatively and qualitatively.
Begin Remediation During the Audit
Before the auditor leaves, you can request a closing meeting that allows you to discuss and review the audit findings to get closure for the non-conformances. You should have a thorough understanding of these findings to respond to them and adopt suitable measures properly. When you resolve these findings, ensure that you document all actions, processes, and justifications to ensure accountability and transparency. Recording it will help you analyze the trends, examine the root cause, and eliminate the cause of the problems. You can start remediating during the audit and deploy corrective actions to pave the path for long-term success. You must consistently monitor and measure the actions to align with the end goals.
The entire certification process does not have to be challenging to tackle. Instead, a streamlined preparation and understanding can help meet each requirement effectively and lead to a successful audit stage that guarantees your organization’s certification.