What is an ISO Quality Audit?

An ISO quality audit is a management tool companies use to evaluate, confirm, and verify activities related to quality. 

The ISO 9000 quality audit determines the effectiveness of an organization’s quality management system (QMS). The results of the International Organization for Standardization (ISO) audit assesses the quality management program. This ISO audit scrutinizes objective evidence to determine the suitability, conformity, and effectiveness of the elements of an organization’s quality management system. 

The ISO 9001 international standard details the requirements for quality management systems. This standard is primarily aimed at manufacturing facilities and manufacturing support organizations.  The ISO 9001 quality audit is the most common ISO standard for audits. The ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify.  

The quality audit determines the suitability of the quality program to the business and to the ISO 9001 standard. The ISO quality audit monitors whether the operations of the quality system conform to the business’ documented quality program. The ISO 9001 quality audit verifies an organization’s quality planning, quality system implementation, quality system measurements, and quality system documentation.

The quality audit examines such things as a company’s policies and procedures, specifications, and quality manual for defined responsibilities and accountability. The quality audit compares an organization’s day-to-day activities to its established documentation. 

An organization should conduct an internal audit and evaluate all the elements and components pertaining to its quality system on a regular basis, according to the requirements of the ISO 9000 quality audit. 

What’s the goal of an internal audit?

The goal of an internal audit is to assess the effectiveness of a company’s quality management system as well as its overall performance. Internal audits demonstrate an organization’s compliance with the quality management system and how its processes are implemented and maintained. In other words, is the company doing what it says it is doing?

A company should carry out internal audits to determine whether various elements within its QMS are effective in achieving the organization’s stated quality objectives. Consequently, company management should develop an appropriate audit plan.

Internal ISO quality audits are conducted by the organization using an internal auditor. An internal auditor is a trained professional employed by an organization to provide independent and objective evaluations of its financial and operational business activities. 

During an ISO 9001 quality audit, the internal auditor verifies that the organization’s quality management system complies with ISO standards and meets the quality objectives of the business. The internal audit must cover all elements of the ISO 9001 standard within a 12 month period.  

Internal audits are an excellent way to prepare for the certification audit. Internal audits often take place during QMS implementation as well as after certification for continuous monitoring.  

In contrast, an ISO 9001 certification audit is the final step before companies receive ISO 9001 certification.  A Registrar from outside your organization must perform the audit to assess the QMS you have implemented with relevant documentation to determine if you have met all of the ISO 9001 requirements.   

Both ISO compliance and ISO certification are voluntary: These aren’t regulations, but recommendations from standards. That said, however, some organizations, such as manufacturers, may require their third-party suppliers to be ISO certified to ensure the quality of their own goods, services, and processes and the security of their information, systems, and networks.

When performed correctly, ISO quality audits are extremely beneficial. ISO quality audits can help a company find problems during implementation and enable the organization to take corrective actions to fix the problems before they are discovered during an external certification audit, the final step before obtaining ISO certification.