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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.
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
Download QR code; Print/export ... ISO members by country Country A2 code Country A3 code Country code No. ... CV: CPV: 132: Cape Verde ...
The sortable table below contains the three sets of ISO 3166-1 country codes for each of its 249 countries, links to the ISO 3166-2 country subdivision codes, and the Internet country code top-level domains (ccTLD) which are based on the ISO 3166-1 alpha-2 standard with the few exceptions noted. See the ISO 3166-3 standard for former country codes.
IATF 16949:2016 replaced ISO/TS 16949 in October 2016 by International Automotive Task Force. [ 2 ] [ 3 ] The goal of the standard is to provide for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the automotive industry supply chain and assembly process.
The ISO 3166/MA updates ISO 3166-1 when necessary. A country is normally assigned new ISO 3166-1 codes if it changes its name or its territorial boundaries. In general, new alphabetic codes are assigned if a country changes a significant part of its name, while a new numeric code is assigned if a country changes its territorial boundaries.
ISO/IEC 7816 is an international standard related to electronic identification cards with contacts, especially smart cards, and more recently, contactless mobile devices, managed jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).
ISO 45001 was proposed at the ISO in October 2013. The committee ISO/PC 283, created in 2013, had direct responsibility for the standardization process. [10] At least 70 countries contributed to the drafting process. [11] Preparation and committee work lasted until December 2015.
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