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ISO 15189. 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).
In India, NABL accreditation is usually the precursor to various government/ regulator/ statutory body recognition's. NABL being a governmental body conducts integrated assessments with regulators such as FSSAI, EIC, APEDA, etc. Integrated assessments simplify the process of recognition, as the laboratory can get accredited and recognized by ...
Website. www.iso.org. The International Organization for Standardization (ISO / ˈaɪsoʊ / [3]) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member countries. [4] Membership requirements are given in Article 3 of the ISO Statutes.
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The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is a global professional association that promotes the fields of clinical chemistry and laboratory medicine. [1] It was established in Paris in 1952 as the International Association of Clinical Biochemists to organize the various national societies of these fields ...
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ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice. ISO 14163:1998 Acoustics – Guidelines for noise control by silencers. ISO 14164:1999 Stationary source emissions – Determination of the volume flowrate of gas streams in ducts – Automated method.
ISO/TS 16949:2009 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); the latest version is based on ISO 9001:2008. The emphasis on a process approach is stronger than in ISO 9001:2008. ISO/TS 16949:2009 contains the full text of ISO 9001:2008 and automotive industry-specific requirements.
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