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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.
ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 does not necessarily mean compliance with ISO 9001 (and vice versa).
Because 'International Organization for Standardization' would have different acronyms in different languages (IOS in English, OIN in French), our founders decided to give it the short form ISO. ISO is derived from the Greek word isos (ίσος, meaning "equal"). Whatever the country, whatever the language, the short form of our name is always ...
CLSI participates in the development of international standards as the Secretariat of ISO Technical Committee (TC) 212, clinical laboratory testing and in vitro diagnostic test systems. This responsibility was delegated to CLSI by the American National Standards Institute (ANSI), an ISO member body. CLSI also serves as the administrator for the ...
DNV Healthcare is a Norwegian-US health care accrediting organisation providing a quality management system constructed in accordance with ISO 9001 and approved by the U.S. Centers for Medicare and Medicaid Services (CMS). ACSA International is a Spanish healthcare accreditation scheme implemented in Spain, Portugal and Brazil.
This is a list of abbreviations used in medical prescriptions, including hospital orders (the patient-directed part of which is referred to as sig codes). This list does not include abbreviations for pharmaceuticals or drug name suffixes such as CD, CR, ER, XT (See Time release technology § List of abbreviations for those).
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Standards for validation and verification of medical laboratories are outlined in the international standard ISO 15189, in addition to national and regional regulations. [1] As per United States federal regulations, the following analytical tests need to be done by a medical laboratory that introduces a new testing device: