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Document management: Quality management software enables companies to manage all product and quality records and documents, including product specifications, work instructions, standard operating procedures (SOPs), quality policies, and training records, among other things, to fulfill highly regulated requirements.
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.
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.
A management system is a set of policies, processes and procedures used by an organization to ensure that it can fulfill the tasks required to achieve its objectives. [1] These objectives cover many aspects of the organization's operations (including product quality, worker management, safe operation, client relationships, regulatory ...
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.
Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...
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