Quality Audit and Quality Auditing

A quality audit is a systematic and independent examination or assessment of an organization's QMS.

It is done to evaluate the effectiveness of an organization's quality controls, identify areas of improvement, and ensure all areas are quality-compliant.

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Quality audit is a verification effort intended at evaluating the degree of conformance to meet a standard specification or procedure of the product, design, process, or system. The quality audit has two components: one is the analysis of the system within which the items of product or service are brought into being, commonly referred to as quality system audits. The other is an analysis of the items themselves, which is called a product or service quality audit and is often part of quality auditing and assurance services.

What is a Quality Audit?

A quality audit is typically conducted by an external or internal quality auditor or audit team at agreed time intervals, ensuring that an organization has a clearly defined system for quality monitoring. It is an essential element of the ISO 9001 quality system standard.

What is Quality Auditing?

Quality auditing is the systematic, independent, and documented review and evaluation of an organization’s Quality Management System (QMS) to determine whether quality activities and results comply with a strategic arrangement that is effectively implemented and appropriate to achieve the organization’s objectives, making it a critical audit in quality management system practices. It also forms a critical part of quality assurance auditing, supporting consistent compliance, risk reduction, and continual improvement.

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Why are Quality audits important?

To ensure the greatest benefit for an organization, audits are crucial for assessing the success of processes, products, and systems—whether existing or newly implemented—ensuring alignment between quality and audit objectives across the organization. This is an important tool for:

Determining the conformity or nonconformity of the quality system elements with specified requirements

Verifying objective evidence of processes

Providing evidence for the reduction and elimination of any problem areas

Ensuring whether the products are fit for use, safe for the consumers and regulations are being followed

Identifying whether the quality policies of organizations meet quality standards adequately

Taking corrective action for deficiencies

Recognizing improvement opportunities

What is the role of the auditor?

An auditor is a professional who understands the business and industry standards and conducts audits as per those standards. Auditors may be internal or external. Internal auditors are employees, whereas external auditors are hired from approved agencies to evaluate systems and products. They play a key role in quality auditing and assurance services, supporting effective audit and quality assurance practices across regulated industries.

What are the types of Quality Audits?

There are different types of quality audits, broadly categorized as follows:

Process audit

A process audit specifies whether a company’s processes are working within defined limits. It measures conformance to any predefined requirements or industry standards along with the effectiveness and adequacy of the process controls as established by procedures, work instructions, training, and process specifications.

Product audit

Product audit inspects whether a particular product or service complies with customer requirements, specifications, and performance standards.

System audit

A system audit confirms that all elements of a management system are effective and appropriate, and have been developed, implemented, and documented as per the specified requirements, validating the performance of the organization’s quality audit system. A quality management system audit measures an organization’s existing quality management system to assure its conformance with contract commitments, company policies, and regulatory requirements, making it a fundamental audit in quality management system activities.

Process audit

A process audit specifies whether a company’s processes are working within defined limits. It measures conformance to any predefined requirements or industry standards along with the effectiveness and adequacy of the process controls as established by procedures, work instructions, training, and process specifications.
Product audit

Product audit inspects whether a particular product or service complies with customer requirements, specifications, and performance standards.
System audit

A system audit confirms that all elements of a management system are effective and appropriate, and have been developed, implemented, and documented as per the specified requirements. A quality management system audit measures an organization’s existing quality management system to assure its conformance with contract commitments, company policies, and regulatory requirements.

First-party, second-party, and third-party audits

First-party audit:

A first-party audit is an internal quality audit designed to measure the performance of the organization’s objectives, identification of problem areas, and to find opportunities for continuous improvement. This audit is conducted by auditors who are employed by the organization being audited.

Second-party audit:

A second-party audit is an external audit conducted by auditors who are hired from outside the organization to conduct an independent audit. Second-party audits are more conventional than a first-party audit as the audit results may impact the buying decisions of the customer.

Third-party audit:

A third-party audit is performed by an external independent organization without conflict of interest resulting in recognition, certification, license approval, a penalty, or a fine being issued by the third-party organization.