Transcription of ISO 13485 差異分析 - twap.sgs.com
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ISO 13485 差異分析 - twap.sgs.com
ISO 13485 2016 Mar 1/7 ISO 13485 Medical devices Quality management systems Requirements for regulatory purposes ISO 13485 :2016 2003 (medical device file) (software validation) Regulatory Validation Sterile Software Proportionate to the risk associated with the medical device 8 3 2019 2 2003 2016 2003 2016 Foreword Foreword 0 Introduction Introduction -- General General -- Process approach Clarification of concepts -- Relationship with other standards Process approach -- Relationship with ISO 9001 -- -- -- Relationship with ISO/TR 14969 -- -- -- ISO 13485 2016 Mar 2/7 2003 2016 Compatibility with other management syst
ISO 13485 差異分析 2016 Mar 2/7 2003 2016 0.4 Compatibility with other management systems 0.4 Relationship with ISO 9001 與ISO 9001 之關連性
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