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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 ). [ 1 ]
Quality audit is the process of systematic examination of a quality system 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 and is a key element in the ISO quality system standard, ISO 9001 .
Failure Reporting (FR). The failures and the faults related to a system, a piece of equipment, a piece of software or a process are formally reported through a standard form (Defect Report, Failure Report). Analysis (A). Perform analysis in order to identify the root cause of failure. Corrective Actions (CA).
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
A measurement system analysis (MSA) is a thorough assessment of a measurement process, and typically includes a specially designed experiment that seeks to identify the components of variation in that measurement process. Just as processes that produce a product may vary, the process of obtaining measurements and data may also have variation ...
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.
Statistical process control is appropriate to support any repetitive process, and has been implemented in many settings where for example ISO 9000 quality management systems are used, including financial auditing and accounting, IT operations, health care processes, and clerical processes such as loan arrangement and administration, customer ...
For example, if a machine is planned to run 100 hours a week, but in reality runs only 50, then the availability is 50%. [3] Performance – compares the ideal output and the actual output. For example, if a certain process is planned to take 10 minutes, but actually takes 20, then the productivity is 50%. [3]