国家实验室认可认证(ISO/OEC17025)咨询内容 发布时间: 2011-10-30 15:20 点击:

 

国家实验室认可认证(ISO/OEC17025)咨询内容
National Laboratory Accreditation ( ISO / OEC17025 ) advisory content
1)实验室情况调研:
1) laboratory investigation:
由咨询师实地参观、调查实验室的总体情况,结合认可的要求提出实验室存在的现状突出问题,确立认可工作的总体思路和目标。
By consulting division site visit, investigation laboratory overall situation, combined with the accreditation requirements presented laboratory existing prominent problems, establish the overall train of thought and target recognition.
2)实验室管理体系设计:
2) laboratory management system:
结合实验室的实际组织架构及实验室认可工作的基本要求,策划设计实验室的组织和管理机构,明确各部门和各岗位的分工,为实验室管理体系有效运行提供组织保证。
Combined with the actual laboratory construction and laboratory accreditation work of the basic requirements, planning the design of laboratory organization and management agencies, the departments and each post division of labor, for the laboratory management system and effective operation to provide organizational guarantee.
3)认可准则培训:
3) accreditation standards training:
通过全员参与认可标准的学习,理解认可工作的基本要求,明确认可准备工作的具体内容和工作方向,为认可工作的顺利进行做好思想总动员并奠定理论基础。
Through full participation recognized standards of learning, understanding the accreditation of the basic requirements, a clear recognition to the working contents and direction of the work, as recognition of work carried out smoothly the ideological mobilization and lay the theoretical foundation.
4)编写实验室管理体系文件:
4) preparation of laboratory management system documents:
实验室管理体系文件共有四个层次组成,第一、二层次文件由咨询师负责根据实验室情况完成初稿后,由实验室负责审查、修订;第三层次文件——作业指导书由实验室结合实际检测工作类型组织编写,咨询师可提供样本和指导;第四层次文件——质量和技术记录,其中的质量记录由咨询师提供样表,实验室结合实际情况进行修订,技术记录由实验室负责规划设计,咨询师进行指导。
Laboratory management system documents were composed of four layers, the first, two level document by consultants responsible for the completion of the first draft of the laboratory, the laboratory responsible for review by, revised; third level document -- instructions by laboratory combining with actual testing work type of tissue preparation, consultants can provide samples and guidance; Fourth level document -- quality and technical records, the records by consultants to provide sample table, laboratory combining with the actual situation are revised, technique of recording from laboratory is responsible for the planning and design, consulting division for guidance.
5)管理体系运行资料填写:
5) fill in the information management system:
在咨询师的指导下,结合认可工作的总体时间进程,填写管理体系运行资料,确保满足认可准则的总体要求。
The consultant under the guidance of the overall time, combined with the accreditation process, complete management system data, to ensure that meet the general requirements of acceptance criteria.
6)内审员培训:
6) internal auditor training:
咨询师负责对内审员进行培训,明确内审的总体要求和基本技巧,提供内审员培训教材,培训后进行书面考核,合格者颁发内审员资格证书。
Consultants responsible for internal auditor training, clear internal auditor general requirements and basic skills, to provide internal auditor training materials, training after the written examination, eligible to issue the certificate of internal auditor.
7)实验室管理体系文件宣贯:
7) laboratory management system implementation:
咨询师协助质量负责人进行实验室体系文件宣贯,确保实验室全体人员应按照体系要求开展认可的准备工作。
Consultant to assist the person responsible for quality control laboratory system document publicizing, ensure the laboratory staff should be in accordance with the system requirements to carry out recognition preparations.
8)实验室管理体系内部审核:
8) laboratory management system internal audit:
由质量负责人主持进行实验室管理体系内部审核,认真检查管理体系和检测活动的运行资料,找出存在的问题并与咨询师讨论确定不符合项,开出不符合项报告。咨询师指导质量负责人编写内部审核报告。
By the quality of person in charge of laboratory management system internal audit, check management system and testing activities of the operation data, find out the problem of existence and counselor discusses identify non-conformances, issue ncr. Consulting division guidance quality responsible to prepare audit report.
9)管理评审:
9) the management review:
咨询师提供管理评审的报告样本,实验室各部门进行工作总结并在咨询师的指导下,由实验室最高管理者组织主持管理评审会议,提出工作中存在的问题及改进的建议。通过会议研究确定需要改进的相关事项,质量负责人编写管理评审报告,咨询师负责管理评审报告的定稿审核。