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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.
ARMA International defines records management as "the field of management responsible for establishing and implementing policies, systems, and procedures to capture, create, access, distribute, use, store, secure, retrieve, and ensure disposition of an organization's records and information". Such a system may be paper-based (such as index ...
Follow regulatory standards that affect the laboratory Customer relationship management Handle the demographic information and communications for associated clients Document management Process and convert data to certain formats; manage how documents are distributed and accessed Instrument calibration and maintenance
This is a list of proprietary laboratory information management systems (LIMS) from businesses and organizations which have articles about them in Wikipedia. BaseSpace Clarity LIMS from Illumina BIOVIA ONE Lab LIMS from Dassault Systèmes
ISO/IEC 27001 is an international standard to manage information security.The standard was originally published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) in 2005, [1] revised in 2013, [2] and again most recently in 2022. [3]
Governance activities ensure that critical management information reaching the executive team is sufficiently complete, accurate and timely to enable appropriate management decision making, and provide the control mechanisms to ensure that strategies, directions and instructions from management are carried out systematically and effectively. [12]
The principles of RIHA are: [3] Principle of legality: data shall be processed in a database belonging to the state information system in the course of performance of public duties, for the purpose of performance of obligations prescribed by an Act, legislation issued on the basis thereof, or an international agreement.
The ISO also produces international standards such as ISO/IEC 27002 to help organizations meet regulatory compliance with their security management and assurance best practices. [5] Some local or international specialized organizations such as the American Society of Mechanical Engineers (ASME) also develop standards and regulation codes. They ...