ISO17025实验室认可168问.docx
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ISO17025实验室认可168问
一实验室认可的意义..................................................................................................................................6
1.什么是实验室认可?
...............................................................................................................6
2.在实验室认可活动中的实验室有什么涵义?
.......................................................................6
3.实验室的顾客有哪些?
...........................................................................................................7
4.我国为什么要推行实验室认可?
...........................................................................................7
5.与实验室认可有关的组织有哪些?
.....................................................................................8
6.使用认可实验室如何有益于政府?
.......................................................................................9
7.认可实验室是如何得到国际承认的?
...................................................................................9
8.实验室为什么要申请认可?
.................................................................................................10
9.实验室是否需要申请多重认可?
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10.实验室申请认可需满足什么条件?
...................................................................................11
11.实验室认可是完全自愿的吗?
..........................................................................................12
12.认可和认证有什么不同?
..................................................................................................12
13.实验室认可和ISO9000认证有什么关系?
......................................................................13
14.实验室认可对全球测量一致性起什么作用?
...................................................................14
15.实验室认可和合格评定有什么关系?
...............................................................................14
二质量要素的理解....................................................................................................................................16
16.为什么要建立质量管理体系?
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17.最高管理者、技术管理层和质量主管在实验室中各担负哪些职责?
...........................16
18.纠正措施的实施由技术管理层负责,还是质量主管负责?
...........................................16
19.质量主管是否应对检测/校准质量承担领导责任?
..........................................................17
20.在检测/校准活动中,实验室员工应对顾客的什么信息承担保密责任?
......................17
21.如何绘制组织结构图?
......................................................................................................18
22.实验室可分配的资源和可使用的权利有哪些?
...............................................................18
23.什么是二级法人的实验室?
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24.二级法人的实验室如何做到质量活动的公正性?
...........................................................19
25.组织结构的功能是什么?
..................................................................................................20
26.如何进行实验室的组织设计?
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27.质量管理和全面质量管理的目标是什么?
.......................................................................21
28.实验室如何加强质量管理?
..............................................................................................22
29.监督员如何实施日常质量监督?
......................................................................................22
30.质量管理部门和监督员的工作有何不同?
.......................................................................23
31.怎样做到“足够的”监督?
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32.监督员由谁担任合适?
......................................................................................................24
33.委托代理应注意什么?
......................................................................................................25
34.授权签字人的数量多少较为合适?
...................................................................................25
35.如何制定实验室质量方针?
..............................................................................................25
36.如何制定实验室质量目标?
..............................................................................................26
37.质量承诺应包括什么内容?
..............................................................................................26
38.实验室有哪些质量管理体系文件?
...................................................................................27
39.如何对文件进行受控管理?
..............................................................................................27
40.如何获得外来文件发布或更新的信息?
...........................................................................28
41.如何获得外来技术文件的文本?
......................................................................................29
42.如何获得国际或外国标准?
..............................................................................................29
43.为什么要进行文件的定期评审?
......................................................................................30
44.如何进行文件的定期评审?
..............................................................................................31
45.外来文件的评审包括哪些内容?
......................................................................................31
46.哪些文件应进行受控管理?
..............................................................................................32
48.技术文件的格式是否需要经过批准?
.................................................................................32
50.何建立文件的识别编号?
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51.上发布文件应注意什么?
..................................................................................................34
52.表格的制定应注意什么?
..................................................................................................35
53.什么是要求的评审?
..........................................................................................................35
54.怎样进行要求、标书和合同的评审?
...............................................................................35
55.在检测/校准分包活动中,发包方和接包方分别承担什么法律责任?
..........................36
56.如何选择服务的供方?
......................................................................................................37
57.实验室如何选择供应商?
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58.采购合同包括什么内容?
..................................................................................................38
59.实验室如何验收设备?
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60.顾客是否有权进入实验室?
..............................................................................................39
61.顾客对质量管理体系起什么作用?
...................................................................................39
63.如何测量顾客满意程度?
....................................................................................................40
64.处理顾客抱怨?
..................................................................................................................41
65.理顾客抱怨应遵循什么原则?
..........................................................................................41
66.纠正措施和预防措施有什么区别?
...................................................................................42
67.纠正和纠正措施有什么区别?
..........................................................................................43
68.如何实施纠正和纠正措施?
..............................................................................................43
69.技术记录的信息包括哪些?
..............................................................................................44
70.什么是原始记录的标识?
..................................................................................................44
71.什么是原始记录的编号?
..................................................................................................45
72.技术记录应保存多长时间?
..............................................................................................45
73.什么是审核?
......................................................................................................................45
74.实验室审核有几种类型?
..................................................................................................46
75.内审和外审有什么不同?
..................................................................................................46
76.内审和管理评审有何不同?
..............................................................................................47
77.实验室内部审核可否履行实验室管理评审职能?
...........................................................47
78.如何在日常工作中验证质量管理体系运行的持续符合性?
...........................................48
79.什么情况下实施附加审核?
..............................................................................................48
80.内审是否必须涉及实验室所有部门和活动?
...................................................................49
81.质量主管在审核活动中的作用是什么?
...........................................................................49
82.内审员的配置应满足什么要求?
......................................................................................49
83.是否经过内审员培训就可以承担内审工作?
...................................................................50
84.内审中的不符合项是如何分类的?
...................................................................................50
85.审核记录包括哪些文件?
..................................................................................................51
86.管理评审主要对什么问题做出决策?
...............................................................................52
87.什么是质量管理体系的适宜性和有效性?
.......................................................................52
88.如何对管理评审提出的改进措施进行跟踪验证?
...........................................................52
89.实验室哪些人员必须经过授权?
......................................................................................53
90.授权签字人与对结果提出意见和解释的人有何不同?
...................................................54
91.操作什么设备应持证上岗?
..............................................................................................54
92.为什么要对关键人员进行授权?
......................................................................................55
93.实验室哪些人员应有任职条件的要求?
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