Quality audit is the process of systematic examination of a quality system carried out by an

internal or external quality auditor or an audit team. It is an important part of organization's

quality management system and is a key element in the ISO quality system standard, ISO 9001.

Quality audits are typically performed at predefined time intervals and ensure that the institution
has clearly-defined internal system monitoring procedures linked to effective action. This can
help determine if the organization complies with the defined quality system processes and can
involve procedural or results-based assessment criteria.

With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the focus of
the audits has shifted from purely procedural adherence towards measurement of the actual
effectiveness of the Quality Management System (QMS) and the results that have been achieved
through the implementation of a QMS.

Audits are an essential management tool to be used for verifying objective evidence of processes,
to assess how successfully processes have been implemented, for judging the effectiveness of
achieving any defined target levels, to provide evidence concerning reduction and elimination of
problem areas. For the benefit of the organisation, quality auditing should not only report non-
conformances and corrective actions, but also highlight areas of good practice. In this way other
departments may share information and amend their working practices as a result, also
contributing to continual improvement.

Quality audits can be an integral part of compliance or regulatory requirements. One example is
the US Food and Drug Administration, which requires quality auditing to be performed as part of
its Quality System Regulation (QSR) for medical devices (Title 21 of the US Code of Federal
Regulations part 820[1]).

Several countries have adopted quality audits in their higher education system (New Zealand,
Australia, Sweden, Finland, Norway and USA) [2] Initiated in the UK, the process of quality audit
in the education system focused primarily on procedural issues rather than on the results or the
efficiency of a quality system implementation.

Audits can also be used for safety purposes. Evans & Parker (2008) describe auditing as one of
the most powerful safety monitoring techniques and 'an effective way to avoid complacency and
highlight slowly deteriorating conditions', especially when the auditing focuses not just on
compliance but effectiveness. [3]

The processes and tasks that a quality audit involves can be managed using a wide variety of
software and self-assessment tools. Some of these relate specifically to quality in terms of fitness
for purpose and conformance to standards, while others relate to Quality costs or, more
accurately, to the Cost of poor quality. In analyzing quality costs, a cost of quality audit can be
applied across any organization rather than just to conventional production or assembly
processes[4

A quality audit is a review in which an auditor analyzes and verifies various records and
processes relating to a company’s quality program. In general, the purpose of a
quality examination is to determine whether the company is complying with its
quality program or whether it needs to make changes to its business practices. A
company may also perform a quality audit in order to determine whether it is
complying with certain quality standards, like those set by the International
Organization for Standardization (ISO) 9000. Simply put, the ISO 9000 is a
certification that a company is following formal business procedures.

Usually, a quality audit is an external audit, meaning it is conducted by an independent auditor or

team of auditors who have expertise in the area. A company may also elect to perform an internal
audit of its quality control systems on a periodic basis. Members of the audit team are typically
professionals who have extensive knowledge about auditing standards, procedures, and
principles. In addition, auditors should have hands-on experience with examining, evaluating,
and reporting on whether each aspect of a quality system is deficient or satisfactory.

In a typical quality audit, the auditor first formulates a system audit plan. As a general rule, this
plan usually details the timeline, scope, and location of the audit. The plan also lists out any
written documentation that will need to be reviewed as well as any interviews that will need to
be conducted. For example, an auditor usually needs to review any of the company’s written
quality management policies, procedures, and manuals. When the plan has been prepared, the
auditor submits it to the company for approval.

Once the audit plan has been approved, the auditor generally meets with any individuals at the
company who are responsible for the company’s quality program. The auditor also examines any
applicable records and investigates whether the company’s businesses practices align with its
written quality program. If data suggests that the company is not complying with its quality
program, the auditor will investigate and document this information. Additionally, the auditor
will note any areas in which the company is complying.