How Should Nonconformities Be Handled During The Iso 9001 Certification Audit?

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Currently, one of the most widely used quality management system standards is ISO 9001. It gives procedures a framework to steadily enhance every aspect of a company. With good cause, more than a million businesses of all kinds are accredited to the ISO 9001 standard worldwide. Due to its adaptability, it may influence organizations in different areas to make necessary adjustments. The ISO 9001 quality management system is the solution if you're looking to create a culture of ongoing improvement. Root and branch process improvements must be made throughout your firm as part of the adoption of an ISO 9001-compliant quality management system. Planning to support risk management strategies and highlight opportunities is a part of this.

The flexibility of the ISO 9001 standard is one of its primary key features. It is utilized by a wide range of companies and customized to meet their particular business needs. The goal of quality management systems like ISO 9001, which provide best-practice procedures and standards to guarantee the most effective operations, is to increase performance in a manufacturing environment.

Understand ...
... first How are audit findings applied? A set of criteria, such as the ISO 9001 requirements, along with quality policies and ISO 9001 procedures, are taken into consideration by the auditor during an audit, and evidence is gathered to show if the criteria are being met. This proof can be in the form of documents, declarations of fact, or other details about the audit criteria. For instance, the ISO 9001 standards for record control mandate that you have controls in place to identify, store, safeguard, retrieve, and keep documents. The auditors will examine your records to ensure that they meet each of these requirements during the audit.

The auditors will assess whether the criteria were met after gathering the audit evidence and comparing it to the criteria. The comparison is intended to demonstrate that the process complies with the requirements, but it may also demonstrate that it does not. An audit nonconformity is noted in the audit report if the process is found to be non-conforming based on the audit findings.

What exactly are audit nonconformities and what do they imply?
Nonconformities found during a registration audit are often categorized by certifying organizations into two categories: major and minor. Both nonconformities need to be addressed, but each can mean a different thing when it comes to the organization certification being granted.

Significant nonconformities are frequently seen as a lack of compliance with a quality management system requirement (QMS). For instance, according to the ISO 9001 requirements, you must stop inadvertent usage of old documents. You might specify in your procedure that employees must utilize the latest edition of ISO 9001 documents that are accessible on your network rather than printing copies to retain at their desks to address this issue. This may be viewed as a significant nonconformity if the auditors discovered that many different employees throughout your organization were using printed versions of outdated procedures for their work.

A minor nonconformity arises when a problem is discovered that is more limited in extent throughout your organization. If the evidence for printed versions of old documents presented above occurred just with one or two persons in one department, the matter would be classified as a minor nonconformity.

What should you do if a nonconformity is discovered?

Whether an audit nonconformity is big or minor, you should still address it by following the corrective action process to make the necessary corrections. The only significant distinction between a corrective action raised internally within the organization and one raised as a result of a certification audit nonconformity in this procedure is who should assess the sufficiency of your plan and carry out the follow-up. While your certification body auditor will document your answer to the nonconformity in their audit report and follow up on the completion of the remedial action at their subsequent audit, this should be done with them when dealing with a certification audit nonconformity.

The certification can be granted when the corrective action plan is received, and the audit team will follow up at the next maintenance audit by the certification body if any minor non-conformities are still present. Minor non-conformities are frequently found during an audit and frequently need to be addressed within a certain timeframe. If there are significant nonconformities, the certification may not be awarded until the necessary corrective action has been taken and has been evaluated by the certifying body auditors.

Source: https://qms9001certificationprocedures.wordpress.com/2023/03/17/how-should-nonconformities-be-handled-during-the-iso-9001-certification-audit/