Mohammad Zaid

Quality Audits
An audit is simply a comparison of observed activities and/or results with documented requirements. More formally, ISO 10011 Guidelines for Auditing Quality Systems, define a quality audit as A systematic and independent examination to determine whether quality activities and related results complied with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.

Benefits of conducting Quality Audits

Audits are conducted to determine if systems, processes and products comply with documented requirements. The evidence provided from audits form the basis of improvement in either the element audited, or in the requirements.

Types of Quality Audits

There are three basic types of Quality Audits: system, products and processes. System audits are the broadest in terms of scope. The system being audited varies, but the most commonly audited system is the Quality System. The Quality System is the set of activities designed to assure that the product or service delivered to the enduser complies with all the quality requirements. Product audits are performed to confirm that the system produced the desired results.

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Mohammad Zaid

Process audits are conducted to verify that the inputs, actions, and output of a given process match the requirements.

Product Audits
Product audits are generally conducted from the customer perspective. There are four facts of quality: quality due to defining the product to meet marketplace requirements; quality due to design; quality due to conformance with design; and quality due to product support. Traditionally, product quality audits were conducted primarily to determine conformance with design. However, modern quality audit standards are designed to determine all four facets of quality. One purpose of product audit is to estimate quality being delivered to customers, thus product audits usually takes place after inspections have been completed. The audit also provides information about how product quality can be improved. In addition, the audit provides another level of assurance beyond routine inspection. Product audits differ from inspection in a number of ways. Two fundamental differences exist: 1) audits are broader in scope than inspections and 2) audits go deeper than inspections.

Process Audit
Process audits focus on specific activities or organizational units. Example includes engineering, marketing, calibration, inspection, discrepant material control, corrective action etc. Processes are organized, value-added manipulations of inputs

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Mohammad Zaid

which results in the creation of product or service. Process audits compare the actual operations to the documented requirements of the operations.

System Audit
System is actually just arrangement of processes. The dictionary definition of a system is a group of interacting, interrelated or interdependent elements forming a complex whole. System audits differ from Process audits primarily in their scope. Where process audits focus on an isolated aspect of the system, system audits concentrate on the relationship between various parts of the system. In the case of quality audit, the concern is with the quality system. The quality system is the set of all activities designed to assure that all important quality requirement, determined, documented, and followed.

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