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ISO 17025:2017 – TESTING AND CALIBRATION LABORATORIES

ISO 17025:2017 – TESTING AND CALIBRATION LABORATORIES What is ISO 17025? ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO 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. In many cases, […]

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Shamkris Group

ISO 15189:2012 – MEDICAL LABORATORIES ACCRIDITATION

ISO 15189:2012 – MEDICAL LABORATORIES ACCRIDITATION What is 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). ISO/TC 212 assigned ISO 15189 to a working group to

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ISO 17065:2012 – PRODUCT CERTIFICATION BODIES ACCREDITATION

ISO 17065:2012 – PRODUCT CERTIFICATION BODIES ACCREDITATION What is ISO 17065? ISO 17065 is a Product Certification Bodies Accreditation Standard. As the name says it loud and clear, this standard is for the bodies that are certifying the quality of a product. The product can either be a physical one or some process or any

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ISO 17020:2012 – INSPECTION BODY

ISO 17020:2012 – INSPECTION BODY What is ISO 17020? ISO 17020 conformity assessment requirements for the operation of varied sorts of bodies performing inspection are developed so as to create confidence within the inspection bodies. Accreditation to inspection bodies may be a procedure by which an authoritative body provides formal recognition of technical competence for

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ISO 17021-1:2015 – CERTIFICATION BODY

ISO 17021-1:2015 – CERTIFICATION BODY What is ISO 17021-1? ISO 17021-1:2015 contains principles and requirements for the competence, consistency, and impartiality of bodies providing audit and certification of all types of management systems. Certification bodies operating to ISO 17021-1:2015 do not need to offer all types of management system certification. Certification of management systems is

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Fairtrade Certification

Fairtrade Certification What is Fairtrade Certification? Fairtrade Certification is a product certification within the market-based movement fair trade. The most widely used fair trade certification is FLO International’s, the International Fairtrade Certification Mark, used in Europe, Africa, Asia, Australia and New Zealand.  Fair Trade Certified Mark is the North American equivalent of the International Fairtrade Certification Mark. As of January 2011, there were over 1000 companies certified to the

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US FDA 510K

US FDA 510K What is US FDA 510K? FDA Medical Device Classification is different from the EU MDR classification. The classification method and criteria also differ.  FDA 510k device classification depends on the intended use and indications of the use of the device. The US FDA has established classifications for approximately 1700 different generic types of devices and

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USA FDA COSMETIC REGISTRATION

USA FDA COSMETIC REGISTRATION What is USA FDA Cosmetic Registration? FDA Cosmetic registration (VCRP) is voluntary. Manufacturers are not required to register their facilities nor their products with the US FDA. The FDA’s voluntary cosmetic registration program is for manufacturers, packers, and distributors of cosmetic products within the United States. VCRP is also called as Voluntary Cosmetic

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