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ISO 15189要求实验室对其自行制定的程序或者质量管理体系中那些与既定要求不相符合的事项进行辨识,并采取相应的纠正措施或者预防措施的调查程序。ISO15189还要求实验室管理层对质量体系的适应性和有效性以及支持患者医疗的活动实施评审,并进行必要的变更。
ISO 15189 requires labs to identify issues that are not in conformity with established requirements in their own procedures or in the quality management system and to take appropriate corrective or preventive investigation procedures. ISO15189 also requires laboratory management to review the conformity and effectiveness of the quality system and the activities that support patient care and make any necessary changes.