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Helps manufacturers to monitor, control, and document quality processes electronically to guarantee that goods are made within tolerance, meet all necessary requirements, and are defect-free. Quality management software is often used in the manufacturing industry to identify potential issues before they occur. [5] [13]
Chapter 10: Improvement; The process-oriented approach to business processes that is addressed in the ISO 9001:2015 is the base of the standard. It looks at the business processes in a process environment in which there are interactions and interfaces that need to be recognized, mapped and controlled by the quality management system.
ISO 9001 states that the Quality Management System requirements of the standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides, however, ISO has also published separate standards which specify Quality Management System requirements for specific industries.
ISO 10007 "Quality management — Guidelines for configuration management" is the ISO standard that gives guidance on the use of configuration management within an organization. [1] [2] "It is applicable to the support of products from concept to disposal." [3] The standard was originally published in 1995, and was updated in 2003 and 2017.
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.
All products that are produced according to such quality management systems can refer to a specific DMR that was used to produce it. The DMR will specify exactly what plastic moulds to use, what software builds to install etc. The production history is part of the Device History Record (DHR).
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