Courtesy: Internal Auditor ISO 13485 This standard adopted by CEN as EN ISO 13485:2012 is harmonized with respect to the European Medical Devices Directive 93/42/EEC. Mexico published on October 11, 2012, a national standard as a Norma Oficial Mexicana (NOM) to control manufacture of medical devices inside the country. NOM-241-SSA1-2012, Buenas Practicas de Fabricación para Establecimientos dedicados […]
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Courtesy: Internal auditor 13485 ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is a voluntary standard, 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. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 […]
Courtesy: Inspection specialist A home inspection is a limited, non-invasive examination of the condition of a home, often in connection with the sale of that home. Home inspections are usually conducted by a home inspector who has the training and certifications to perform such inspections. The inspector prepares and delivers to the client a written report of […]
Courtesy: Inspection specialist In international trade several destination countries require pre-shipment inspection. The importer instructs the shipper which inspection company should be used. The inspector makes pictures and a report to certify that the goods that are being shipped and produced are in accordance with the accompanying documents. Commodity inspection is other term that is used between buyers […]
Courtesy: Inspection specialist An inspection is, most generally, an organized examination or formal evaluation exercise. In engineering activities inspection involves the measurements, tests, and gauges applied to certain characteristics in regard to an object or activity. The results are usually compared to specified requirements and standards for determining whether the item or activity is in line with these targets, often with a Standard Inspection Procedure in place […]
Courtesy: Inspection and certification service Most fire equipment needs to be inspected to make sure in the event of a fire, every effort has been taken to make sure it doesn’t get out of control. Extinguishers are to be inspected every month by law and inspected by a servicing company at least once a year. […]
Courtesy: Inspection and certification services An inspection is, most generally, an organized examination or formal evaluation exercise. In engineering activities inspection involves the measurements, tests, and gauges applied to certain characteristics in regard to an object or activity. The results are usually compared to specified requirements and standards for determining whether the item or activity is in line with these targets, often with a Standard Inspection […]
Courtesy: Inspection and certification services Another common type of certification in modern society is product certification. This refers to processes intended to determine if a product meets minimum standards, similar to quality assurance. Different certification systems exist in each country. For example, in Russia it is the GOST R Rostest. Other types include: A type certificate is issued to signify […]
Courtesy: Inspection and certification service Certification is the provision by an independent body of written assurance (a certificate) that the product, service or system in question meets specific requirements. It is the formal attestation or confirmation of certain characteristics of an object, person, or organization. This confirmation is often, but not always, provided by some form of […]
Courtesy : Inspection and certification service The Testing, Inspection and Certification (TIC) sector consists of conformity assessment bodies who provide services ranging from auditing and inspection, to testing, verification, quality assurance and certification. The sector consists of both in-house and outsourced services. Definition of Testing, Inspection and Certification services The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), international standard-setting bodies composed of representatives from various national standards organizations, […]