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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 ]
ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization 's Technical Committee 212 (ISO/TC 212).
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 ensures that an organization, product or service consistently functions as intended. It has four main components: quality planning, quality assurance, quality control, and quality improvement. [1] Quality management is focused both on product and service quality and the means to achieve it.
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent.
Management Representative: A designated representative communicates with top management and ensures the quality management system is effectively implemented. Certification Operations Personnel : Individuals directly involved in the day-to-day operations of the certification process.
GMP is typically ensured through the effective use of a quality management system (QMS). [1]: " The Basis for GMP", [ 2 ] Good manufacturing practice, along with good agricultural practice , good laboratory practice and good clinical practice , are overseen by regulatory agencies in the United Kingdom, United States, Canada, various European ...
American Society for Quality (ASQ) Abbreviation: ASQ: Formation: 16 February 1946; 78 years ago (): Founder: George D. Edwards: Type: Professional association: Purpose: To provide the quality community with training, professional certifications, and knowledge to a vast network of members of the global quality community.
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