ISO 9001 Internal Audits Overview

ISO 9001 Internal Audits is a requirement of ISO 9001:2015 standard as per clause 9.2. These audits are used to assess the effectiveness of an organization's quality management system, identify areas for improvement, and meet the requirements of ISO 9001:2015 Standards. In this article, we'll provide you with a comprehensive guide to plan, conduct and complete the ISO 9001 Internal Audits process.

Preparation for ISO 9001 Internal Audits

Before conducting an ISO 9001:2015 Internal Audit, it's essential to prepare effectively. The preparation process involves several steps,

Establish Audit Objectives

Start by determining the scope of your audit and what specific areas you want to assess. This will help you define your audit objectives and ensure that you conduct a thorough and comprehensive audit.

Determine the Audit Criteria

Audit criteria refer to the standards and regulations against which you'll assess your quality management system. You need to identify the applicable standards and regulations and use them as a basis for your audit.

Develop an audit schedule  Audit Plan

The audit schedule will indicate the overall plan for the year, including periodicity. 

Internal audit frequency shall be based on a defined procedure, based on the importance of the process, based on previous performance of the internal audit, or based on a significant change in the process including roles and responsibilities.

Based on the audit schedule audit plan shall be prepared to indicate the organization process, audit date, audit time, and auditor details. scope of the audit, audit criteria. 

Selection of internal auditor

The internal auditor shall know the requirements of ISO 9001:2015 standard and the Organization's overall Quality management system and Process procedure. The internal auditor shall not audit their own function to maintain impartiality

Organizations train internal auditors by providing internal auditor training. This training can be provided by external component agencies or internal competence personnel. 

Comminate audit plan

The audit plan shall be communicated to the respective auditee in advance may be one month prior to the scheduled internal audit. And one week earlier it can be reconfirmed.

Reference documents 

Internal audit schedule (editable format)

Internal audit plan (editable format)

Qualified internal auditor list (editable format)

How to conduct ISO 9001:2015 Internal Audits

As per the audit plan internal audit will contact the respective auditee. 

Internal audit needs to be conducted as per defined criteria which means an applicable clause of ISO 9001:2015 standard requirement, and applicable procedure of the process. 

During the audit, the internal auditor will verify documents, records, and other forms of evidence to conclude the implementation level. It's important to note that the internal auditor shall note  compliance, non-compliance, and opportunities for improvement observed during the audit and report it. If there is any non-conformity reported during the audit it is important that the respective audit understand and accept the non-conformity.

Reporting on ISO 9001 Internal Audits

Once the respective process audit is complete, the internal auditor will prepare an audit report per the defined organization format and communicate the findings to the auditee.

It is advisable to share the first non-conformity if any since Auditee needs to take corrective action on raised non-conformity. Overall audit results shall be shared with top management.

Reference documents 

Internal audit report (editable format)

Corrective action (editable format)

Follow-Up on Corrective Actions

Follow-up on corrective actions is an integral part of the internal audit process and helps to ensure that nonconformities are addressed appropriately.

Reference documents 

Internal audit report (editable format)

Corrective action (editable format)

Conclusion

In conclusion, ISO 9001 Internal Audits are crucial for organizations to assess the effectiveness of their quality management systems and identify areas for improvement. Preparation is key to conducting a successful audit, including establishing audit objectives, determining audit criteria, developing an audit plan, selecting internal auditors, and communicating the audit plan to the auditee. During the audit, the internal auditor verifies documents and records to conclude the implementation level and notes both compliance and non-compliance. Reporting on the audit findings is an essential step, and follow-up on corrective actions is necessary to ensure non-conformities are addressed appropriately. By following this comprehensive guide, organizations can conduct successful ISO 9001 Internal Audits and continually improve their quality management systems.