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Quality audit is the process of systematic examination of a
quality system A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). I ...
carried out by an internal or external quality auditor or an audit team. It is an important part of an organization's
quality management system A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). I ...
and is a key element in the
ISO ISO is the most common abbreviation for the International Organization for Standardization. ISO or Iso may also refer to: Business and finance * Iso (supermarket), a chain of Danish supermarkets incorporated into the SuperBest chain in 2007 * Iso ...
quality system standard,
ISO 9001 The ISO 9000 family is a set of five quality management systems (QMS) standards that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 90 ...
.


Purpose

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 The ISO 9000 family is a set of five quality management systems (QMS) standards that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 90 ...
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 A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). I ...
(QMS) and the results that have been achieved through the implementation of a QMS. 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. 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 organization, 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 The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
, which requires quality auditing to be performed as part of its
Quality System Regulation Quality may refer to: Concepts *Quality (business), the ''non-inferiority'' or ''superiority'' of something *Quality (philosophy), an attribute or a property * Quality (physics), in response theory *Energy quality, used in various science discipl ...
(QSR) for medical devices (Title 21 of the US
Code of Federal Regulations In the law of the United States, the ''Code of Federal Regulations'' (''CFR'') is the codification of the general and permanent regulations promulgated by the executive departments and agencies of the federal government of the United States. ...
part 820). Several countries have adopted quality audits in their higher education system (New Zealand, Australia, Sweden, Finland, Norway and USA) 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.


Format

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 In process improvement efforts, quality costs or cost of quality is a means to quantify the total cost of quality-related efforts and deficiencies. It was first described by Armand V. Feigenbaum in a 1956 Harvard Business Review article. Prior to ...
or, more accurately, to the
Cost of poor quality Cost of poor quality (COPQ) or poor quality costs (PQC), are costs that would disappear if systems, processes, and products were perfect. COPQ was popularized by IBM quality expert H. James Harrington in his 1987 book ''Poor Quality Costs''. COP ...
. In analyzing quality costs, a cost of quality audit can be applied across any organization rather than just to conventional production or assembly processesHoward, W. Jeffery. ''The Cost of Quality Audit''. 2001.


See also

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DQS-UL DQS Holding GmbH based in Frankfurt am Main is the holding company of the worldwide DQS Group. The group provides assessments and certifications of management systems and processes of any type. History DQS was founded in 1985 in Berlin and wa ...
*
Final quality audit The final quality audit (FQA) process, in the electronic hardware manufacturing world, is the last process flow before shipping a product. This process is established to ensure the unit has gone through and passed all the manufacturing or test proc ...
*
Quality management Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only ...
*
SGS S.A. SGS (formerly Société Générale de Surveillance (French for ''General Society of Surveillance'')) is a Swiss multinational company headquartered in Geneva, which provides inspection, verification, testing and certification services. It has ...
* TÜV Rheinland


References

;Sources * Pyzdek, T, "Quality Engineering Handbook", 2003, * Godfrey, A. B., "Juran's Quality Handbook", 1999, * Seaver, M., "Implementing ISO9001:2000", 2001, {{Authority control
Audit An audit is an "independent examination of financial information of any entity, whether profit oriented or not, irrespective of its size or legal form when such an examination is conducted with a view to express an opinion thereon.” Auditing ...
Types of auditing