To ensure that quality is maintained throughout the pharmaceutical or healthcare organization, frequent audits, both internal and external, are required to assess the quality and effectiveness of the processes, systems, and personnel employed by the company. Audits are an important part of quality assurance and the quality management system. In essence, the audit verifies the effectiveness of a quality management system and acts as a hands-on management tool for achieving continual improvement.

As defined in ISO 19011:2018—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.”

An audit can also be defined as a process that is planned, risk-based, and centred on continuous improvement, not only concerned with making assessments to determine whether agreed upon requirements are met but with also examining ways to increase those standards.

A quality audit is a systemic and independent examination and evaluation to determine whether quality activities and results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.

Audits are about assessing compliance, which can be taken as an affirmative indication or judgment that the supplier of a product or service has met requirements.

Compliance is an affirmative indication or judgement that the supplier of a product or service has met the requirements of the relevant specifications, contract or regulation; also, the state of meeting the requirements.

Compliance is something that meets both the text and the spirit of a requirement. Where compliance is not met, this is a ‘non-compliance’ (or ‘non-conformance’, depending on which audit standard is followed). Conformance is an affirmative indication or judgment that a product or service has met the requirements of the specs or regulations, and a non- conformance is the opposite of this. All non-conformances must be addressed through corrective and preventative actions, based on action plans, implementing a revision, and then assessing the success of that revision after an appropriate time period has elapsed (an efficacy check).