[The Activity to Successfully Acquire ISO 15189 Accreditation].

Junko Shoji, Shin-Ichi Fujimaki, Mitsuo Kaku
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Abstract

Our facilities acquired ISO 15189 accreditation in April 2011. The lead time was a little less than 2 years. I reported on the lead time and activity after ISO 15189 acquisition. I reported how creating a quality manual and SOP was advanced as preparation work. I showed the examination method in detail and the process after examination. I think an increase in per- sonnel as internal auditors is important for quality management system maintenance.

[成功获得ISO 15189认证的活动]。
我们的设施于2011年4月获得ISO 15189认证。交付时间不到2年。我报告了获得ISO 15189后的交货时间和活动。汇报了制作质量手册和SOP的准备工作。我详细展示了考试方法和考试后的过程。我认为增加内部审核员的数量对质量管理体系的维护是很重要的。
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