论文部分内容阅读
文件是质量管理体系策划的结果,是实施体系有效运行的基础,也是进行质量改进的依据。为了使文件的适宜性、符合性、有效性与国家相关法律法规及质量体系标准的要求相符合,确保质量管理体系有效运行,血站按照“一法两规”[1~3]的要求,定期(通常为1年)对文件进行评审。但在督导检查中发现,文件评审仍存在一些问题,甚至有些盲点。我们结合自己的实践,谈一些体会。
Documents are the result of quality management system planning, the basis for the effective operation of the implementation system, and also the basis for quality improvement. In order to make the suitability, conformity and validity of the documents in conformity with the requirements of relevant national laws, regulations and quality system standards, and ensure the effective operation of the quality management system, Requirements, regular (usually 1 year) to review the document. However, in the supervision and inspection found that the file review there are still some problems, and even some blind spots. We combine their own practice, talk about some experience.