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4.1.2内部因素和外部因素A公司在建立IS09001:2015和ISO13485:2016质量管理体系时,应根据自身实际进行内部因素和外部因素的识别、分析,对影响其实现质量管理体系预期结果的各种外部和内部因素进行必要的管控。这些内部因素和外部因素可以包括需要考虑的正面和负面要素或条件。B内部环境因素要考虑公司的内部管理、价值观、...
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ISO 15223-2-2010 医疗器械.用于医疗器械标签、作标记和提供信息的符号.第2部分符号的制定、筛选和批准 高清.pdf PD CEN TR 17223-2018 关于EN ISO 13485_2016 (医疗器械,质量管理体系,监管要求)和欧洲医疗器械法规和体外诊断医疗器械法规之间关系的指导.pdf ISO TR 24971-2020 中文医疗器械ISO14971应用指南.pdf...
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