香港ISO13485認證 ISO13485醫療器械質量體系發展簡介 发布时间: 2020-10-02 11:16 点击:
香港ISO13485認證 ISO13485醫療器械質量體系發展簡介
Brief introduction to the development of ISO13485 medical device quality system in Hong Kong
隨著曆史的發展,ISO組織在此基礎上又將此標准進行了修訂,升級爲ISO13485:2003。大多數醫療設備生産廠家在建立質量管理體系時,開始把ISO9001:2000版+ISO13485:2003版+CE認證作爲壹攬子解決方案來考慮。
With the development of history, ISO revised the standard and upgraded it to ISO13485:2003. Most medical equipment manufacturers began to consider ISO9001:2000 + ISO13485:2003 + CE certification as a package solution when establishing quality management system.
醫療器械行業壹直將ISO 13485標准(中國等同轉換標准號爲YY/T0287)作爲質量管理體系認證的依據。這個標准是在ISO 9001:1994標准的基礎上,增加了醫療器械行業的特殊要求制定的,也就是所謂1+1的標准。
The medical device industry has been taking ISO 13485 standard (Chinese equivalent conversion Standard No. YY / T0287) as the basis of quality management system certification. This standard is based on the ISO 9001:1994 standard, adding the special requirements of the medical device industry, that is, the so-called 1 + 1 standard.
因此,滿足ISO 13485標准也就符合ISO 9001:1994標准的要求。ISO 9001:2000標准頒布以後,ISO/TC 210又頒布了新的ISO 13485:2003標准(中國等同轉換的YY/T 0287-200X標准正在報批)。
Therefore, to meet the requirements of ISO 13485 is to meet the requirements of ISO 9001:1994. After the promulgation of ISO 9001:2000 standard, ISO / TC 210 issued a new ISO 13485:2003 standard (YY / T 0287-200x standard of equivalent conversion in China is being submitted for approval).
日前,BS EN ISO 13485:2012(《醫療器械質量管理體系用于法規的要求》)已更新,但此次更新沒有改變標准的主體內容(僅前言和附件部分修改)且僅限歐洲範圍(EN標准),後續更新進程還請關注中鴻認證服務。
Recently, BS EN ISO 13485:2012 (medical device quality management system for regulatory requirements) has been updated, but this update does not change the main content of the standard (only the introduction and annex part of the modification) and is limited to the European scope (EN standard). Please pay attention to Zhonghong certification service in the follow-up update process.
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