ISO 9001 Audit: Explanation of the Process and Preparation Steps

ISO 9001 Audit: Explanation of the Process and Preparation Steps
5 min read
27 December 2022

ISO audit standards might vary widely from industry to industry. The purpose of an ISO audit is to determine whether or not a company's management systems adhere to all applicable regulations and guidelines. Existing and potential management system issues are identified and solutions are recommended during audits. Reach out to Aegis if you need help with an ISO 9001 audit.

An ISO audit is a comprehensive evaluation of your organization's infrastructure, personnel, and procedures to determine how well they measure up to the ISO standards to which your company has committed. Research has shown that businesses that implement ISO 9000-based quality standards see an improvement in customer satisfaction of 18% and a reduction in costs of 15%.

Audit Types

  • Internal

When a company does an internal audit, it is essentially doing an evaluation of its own Quality Management System (QMS). One of the numerous benefits of doing an internal audit is better preparation for any external audits that may be forthcoming. In order to give unbiased results, the internal auditor needs to be completely detached from the department under scrutiny. 

By having many auditors, we can be confident that no one will be requested to inspect their own department. ISO 9001 mandates regular internal audits, which are critical to the health of your quality management system.

  • External

"External audits" refer to inspections carried out by parties outside of the organization being audited. If a current or potential customer conducts an audit of your business, they are looking to ensure that you can fulfill their needs. 

Supply chain audits could be conducted on both active and prospective vendors. Audits of suppliers can be helpful for confirming that the organization is following the rules set forth by law for the administration of its vendors.

  • Certification

Once you've decided on a registrar, they'll perform an audit to ensure your company follows ISO 9001 standards before issuing a certificate. There are normally two parts to an audit performed for official certification. 

An auditor will interview key personnel on-site and/or through video conference and analyze all relevant documents to ensure your company is in compliance with ISO 9001 standards. Audits for maintaining certification are normally performed every three years.

  • Monitoring and Inspection

Consistent audits of your Quality Management System (QMS) and ISO standards will be performed by your registrar. The primary distinction between certification audits and surveillance audits is that the latter is not required for attaining or maintaining certification. Usually, your registrar will handle them once a year.

Auditing Methodology for ISO 9001

Conducting an internal audit in line with ISO 9001 is the best way to ensure that your Quality Management System (QMS) and associated processes are up to snuff. Here are four tips for conducting a more in-depth internal ISO 9001 audit:

  • Schedule The Audit

Make it a yearly goal to have an internal ISO 9001 audit performed. This, of course, varies from company to company, and, depending on the complexity of your QMS, may demand more frequent internal auditing. 

It is just as crucial to plan the audit's scope and criteria as it is to prepare the audit's schedule. This will provide the chosen auditors with a sound basis upon which to conduct their audit.

  • Gather the Audit Team

Depending on criteria including corporate size, complexity, and the extent of auditing services required, an auditing team might consist of anywhere from a specific individual to a large organization. A good auditing team will have neither a personal stake in the audit's results nor any prior familiarity with the audited processes or systems. 

It's a great method to acquire an objective perspective. Poorly trained internal auditors may miss important audit findings if they are not given precise auditing instructions, which could lead to a company failing to meet ISO 9001 standards.

  • Start ISO 9001 Auditing

After forming your ISO internal audit team and conducting rigorous training on the auditing procedure and goals during your first meeting, you can now begin the actual auditing process. 

As part of the ISO internal audit, we recommend looking into the following four areas:

  • Quality Management System (QMS) documentation review.
  • Engagement of staff to elicit varied reactions to outcomes.
  • Recognizing the inner workings of management and figuring out how everything fits together.
  • Examination of the actual functioning of the systems and processes.

It can be difficult for your team to perform a thorough examination of all of the systems and processes required for an internal ISO 9001 audit. Better audit results and complete conformance with ISO requirements can be achieved through the use of streamlined data-collecting tools, which also lessen the burden of having to remember and re-enter insights.

  • Thorough Examination Of The Data

One of the most prevalent barriers to achievement at this level is an inability to quickly and properly organize the data into clear and helpful reports. The QMS needs to be able to centralize audit data and provide meaningful reports for management review, but its primary purpose is to encourage a culture of continuous improvement beyond what is required by ISO's QMS standards.

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Sharukh Khan 7
Joined: 1 year ago
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