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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.
ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.
The ISO 9004:2009 document gives guidelines for performance improvement over and above the basic standard (ISO 9001:2000). This standard provides a measurement framework for improved quality management, similar to and based upon the measurement framework for process assessment. The last major revision was published on 15 September 2015.
Quality control separates the act of testing products to uncover defects from the decision to allow or deny product release, which may be determined by fiscal constraints. [6] For contract work, particularly work awarded by government agencies, quality control issues are among the top reasons for not renewing a contract. [7]
The company-wide quality approach places an emphasis on four aspects (enshrined in standards such as ISO 9001): [28] Elements such as controls, job management, adequate processes, performance and integrity criteria, and identification of records; Competence such as knowledge, skills, experiences, qualifications
System suitability – A test run each time an analysis is performed to ensure the test method is acceptable and is performing as written. This type of check is often run in a QC Lab. Usually, system suitability is performed by analyzing a standard material (House standard or reference standard) before the unknowns are run in an analytical method.