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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 these standards 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.
Quality management software centralizes the storage of these documents. Regulatory compliance: To decrease compliance risks, quality management software is used within companies to make sure they comply with ISO, OSHA, FDA, and other industry norms and requirements. The software makes closed-loop corrective and preventive action procedures ...
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". [1] This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): [2] [3]
The standard provides a framework for organizations to define a quality model for a software product. On doing so, however, it leaves up to each organization the task of specifying precisely its own model. This may be done, for example, by specifying target values for quality metrics which evaluates the degree of presence of quality attributes.
As the period for transition from the 1994 to 2000 standards passed, AS 9100B was released in 2004 as an administrative revision to delete Section 2 of the Revision A standard. [12] AS 9100 Revision C (2009), Quality Management System – Requirements for Aviation, Space and Defense Organizations
This is a list of published [note 1] standards and other deliverables of the International Organization for Standardization (ISO). [note 2] For a complete and up-to-date list of all the ISO standards, see the ISO catalogue. [1] The standards are protected by copyright and most of them must be purchased.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
The Standard distinguishes between customer-oriented processes, supporting processes and management processes. This process-oriented approach is intended to improve the overview of the whole process. This is not an isolated process, but a combination of all interacting business processes which affect the quality performance of a firm.