What Is Auditing?

Quality Glossary Definition: Audit

Auditing is the on-site verification activity, such as inspection or examination, of a process or Quality Systems, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step.

As defined in ISO 19011:2011—Guidelines for auditing management systems, an audit is a “systematic, independent and documented process for obtaining audit evidence [records, statements of fact or other information which are relevant and verifiable] and evaluating it objectively to determine the extent to which the audit criteria [set of policies, procedures or requirements] are fulfilled.” Several audit methods may be employed to achieve the audit purpose.

There are three discrete types of audits: product (which includes services), process, and system. However, other methods, such as a desk or document review audit, may be employed independently or in support of the three general types of audits.

Some audits are named according to their purpose or scope. The scope of a department or function audit is a particular department or function. The purpose of a management audit relates to management interests such as assessment of area performance or efficiency.

An audit may also be classified as internal or external, depending on the interrelationships among participants. Internal audits are performed by employees of your organization. External audits are performed by an outside agent. Internal audits are often referred to as first-party audits, while external audits can be either second-party, or third-party.

According with the Mexican GMP’s Regulations recently published, The Internal Audits could be also identified as Self-Inspections. The External Audits are identified as Supplier Audits, Meanwhile the Third Party Audits are performed by Certification Organizations or any Regulatory Authority.