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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 [2]).
all overseen by management and quality audits. Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement procedures tailored to ...
A CQA is capable of using various evaluation techniques to identify a production system's strengths and weaknesses in quality control. [1] A quality audit is a process that involves the systematic identification and examination of a production quality system. A Certified Quality Auditor must analyze all elements of a quality system and assess ...
Other commonly audited areas include: secretarial and compliance, internal controls, quality management, project management, water management, and energy conservation. As a result of an audit, stakeholders may evaluate and improve the effectiveness of risk management, control, and governance over the subject matter.
The ISO 9000 family is a set of international standards for quality management systems.It was developed in March 1987 by International Organization for Standardization.The goal of it is to help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service. [1]
The terms "quality assurance" and "quality control" are often used interchangeably to refer to ways of ensuring the quality of a service or product. [3] For instance, the term "assurance" is often used in a context such as: Implementation of inspection and structured testing as a measure of quality assurance in a television set software project ...
Based on ISO 9001:1994, the quality management system includes all elements of QS-9000, with an additional four requirements specific to VDA 6.1 as follows: Element 06.3 on "Recognition of Product Risk ": This the risk of the product, failing to fulfil its stipulated function, and its effect on the whole assembly.
Generally Accepted Auditing Standards, or GAAS are sets of standards against which the quality of audits are performed and may be judged. Several organizations have developed such sets of principles, which vary by territory.