What to Expect From The ISO 9001 Certification Audit Questions?

What to Expect From The ISO 9001 Certification Audit Questions?

A third-party certification authority must conduct a certification audit once you have developed and implemented a Quality Management System (QMS) following the standards of ISO 9001:2015 to confirm that your QMS complies with the standard. You can only do this if you want to be able to advertise that you have a QMS and claim conformity with the standard.

Auditing is essential for establishing ISO 9001 certification for the company as it is due to internal and external audits that the company can establish the standards for quality management and implement knowing the quality gap analysis. To learn more about ISO 9001 Auditing, you can click here

Employees of a company may feel anxious during this period, particularly if they have never had an audit conducted by outsiders. Even people accustomed to internal audits may feel uneasy with external auditors. What will the auditors, therefore, inquire about when they visit your business for the initial certification audit?

What Queries Will The Auditor Make?

An auditor will use various techniques to attempt and get answers to their queries, including record reviews, employee observation, and employee interviews. Even though it is impossible to document every question that might be asked, it is useful to be aware of their primary inquiries and some potential information-seeking techniques:

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Is Each Standard Clause Addressed? 

The majority of these questions are addressed during the documentation internal audit, during which the auditors examine your company's recorded procedures and compare them to the criteria of ISO 9001 to ensure that each complies. However, certain operations are not documented. The auditors will then attempt to determine how these undocumented procedures are carried out to verify them to the specifications. They can ask, "Tell me how this procedure is done," "Show me how you conduct this process," or something similar. This will provide them with the data they need to confirm that your procedure complies with ISO 9001 standards.

Are The Procedures Reliable?

The consequences of the process must be consistent for it to be effective, even though certain tiny deviations across operators, such as the order in which a form is filled out, may be allowed. An auditor may conclude that an inconsistent process is problematic if they observe three purchasing personnel write a purchase order. At the same time, each follows a separate set of procedures, and the results of the purchasing process are so dissimilar that mistakes may be made. 

Has Every Procedure Been Examined?

The external auditors will want to confirm that you have performed your duties and begun assessing your QMS once they have verified that the relevant processes and policies have been established. This process is known as the internal audit process. The auditors will inquire about the internal audit schedule and documentation of completed internal audits, check that internal audit records like audit reports are present, and ensure that conclusions were communicated, addressed, and followed up on.

Have You Taken The Necessary Corrective Action?

The corrective action procedure is crucial in addressing any internal audit findings or other findings of systematic non-conformances. How has this procedure been put into practice? Are you completing your remedial actions on time? How successfully do you ensure that your corrective measures are working to stop an issue from happening again? You should be prepared to demonstrate this by reviewing numerous completed corrective actions.

How Have You Used Risk-Based Thinking In Practice? 

This is a new topic of the ISO 9001:2015 edition. Thus certification auditors will undoubtedly have questions about it. How have you begun integrating risk assessment into all critical areas, like contract, compliance, authorization and design? How have you modified the traditional preventive action procedure to account for risk?

Has The System Undergone A Management Review?

How well your senior management participates in assessing the QMS results and addressing any needs, such as allocating resources to correct problems, is just another area of third-party audit concern. Be prepared for the management review to be examined, and be able to present the review's findings. Did the examination result in the assignment of resources? Was every aspect examined? Was the review's main focus on problem areas?

How Have You Geared Up For Growth?

Constant improvement is one of the QMS's key goals and must be planned for. The auditors will anticipate that you have strategies to execute improvement work even though you might not have many of them finished. What kind of development are you expecting? What have been your quality goals, and how closely are you monitoring them to make progress? Can you name the areas where you hope to see improvement?

Prepare Your Employees To Make The Certification Audit Simpler.

Remembering that auditors are looking to confirm compliance rather than uncover something incorrect is crucial. Generally, the auditor only wants people to provide the information they are aware of during the audit rather than making it up; if they need to seek a particular document, that is okay. The auditor's ultimate goal is to show that the scheduled actions were carried out.

We're all anxious about the unknown, but employees who worry about providing the incorrect answer to a query in an audit for which they haven't even prepared tend to be more anxious than others. It will be much simpler for them to answer on the audit day if your staff knows the questions the auditors might ask and the data they are attempting to access. The finest preparation you can make is this.

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