GB/T 15000.7-2001 标准样品工作导则(7) 标准样品生产者能力的通用要求

ics01.120

A00

中华人民共和国国家标准

GB/T15000.7-2001

代替GB/T15000.7-1997

标准样品工作导则(7>

标准样品生产者能力的通用要求

Directivesfortheworkofreferencematerials(?)一

Generalrequirementsforthecompetenceof

referencematerialproducers

(ISOGuide34:2000,IDT)

2001一09一06发布2002一01一01实施

中华人民共和国发布

国家质量监督检验检疫总局

GB/T15000.7-2001

目次

前言········、、·····················皿

ISO前言····················································。·····。···············。·································……N

引言·········，·············································································。······。···················……V

1范围·····································································。···········。·····························……1

2规范性引用文件·····································································……二‘““二“·‘········……1

3术语和定义································。·········。···············。·················，·······················。·……1

4组织和管理要求···························，·····························································………‘…2

4.1质量体系要求·····························································。············。·····················……2

4.2组织和管理·········································································。·························……2

4.3文件和信息控制·····························································································……3

4.4申请、投标和合同评审········。··········，····························································。······……4

4.5合作者的选用················································································。···············……4

4.6服务和供给的获得································································……·‘·‘‘·········……””二4

4.7用户反馈························································································。·············……4

4.8不合格标准样品的控制··································································.········...……4

4.9纠正措施······································································································……5

4.10预防措施······································································································……5

4.11记录············································‘·······························································……5

4.12内部审核······································································································……6

4.13管理评审··························。···········································································……6

5技术和生产要求································································································，··…6

5.1管理、人员和培训·····························································································……6

5.2合作者········，···，，，·，，、··，、·······，··，、、·····、··················································……7

5.3生产策划······································································································……7

54生产控制······································································································……8

5.5环境··········。············································································。····················……8

5.6材料的处置和贮存···················································································……“二’“8

5.7发放后的服务·························································································……“·“二9

5.8材料制备·················································································。····················……9

5.9均匀性和稳定性评定·······················································································……9

5.10测量方法·10

5.11测量设备···································································································……10

5.12溯源性及确认·················································································。···········……10

5.13数据评估···································································································……11

5.14测定·········································································································……n

5·15特性值及其不确定度的确定·····················。···············································..·...……H

5.16提供给用户的证书和信息····················。····················································.·..·……12

l

GB/T15000.7-2001

附录A(资料性附录)标准样品特性值的溯源性实例········。··········································……13

A.1溯源性的概念········。····························。·······················································……13

A.2标准样品定值···················································································。·········……13

A.3实例·········································。·······························································……14

参考文献············································································································……17

GB/T15000.7-2001

前言

GB/T15000在《标准样品工作导则》的总标题下，分成7个部分，即:

GB/T15000.1-1994标准样品工作导则(1)在技术标准中陈述标准样品的一般规定

GB/T15000.2-1994标准样品工作导则((2)标准样品常用术语及定义

GB/T15000.3-1994标准样品工作导则((3)标准样品定值的一般原则和统计方法

GB/T15000.4-1994标准样品工作导则(4)标准样品证书内容的规定

GB/T15000.5-1994标准样品工作导则((5)化学成分标准样品技术通则

GB/T15000.6-1996标准样品工作导则((6)标准样品包装通则

GB/T15000.7-2001标准样品工作导则((7)标准样品生产者能力的通用要求

本部分是其中的第7部分。

本部分是等同采用ISO指南34:2000((标准样品生产者能力的通用要求》，对GB/T15000.7-1997

《标准样品工作导则标准样品生产者的质量体系》修订而成。

GB/T15000.7-1997是等同采用ISO指南34:1996版本制定的，该版指南中只规定了在标准样

品中如何实施ISO/IEC指南25和ISO9000族标准的解释，没有列人ISO/IEC指南25和ISO9000族

标准中关于生产能力的一般要求。而ISO指南34:2000则根据标准样品研制、生产发展的要求，规定了

标准样品生产者必须证明其生产能力满足质量体系运行的通用要求。所以本部分及时地等同采用了

ISO指南34:2000,

本部分与GB/T15000.7-1997相比，主要变化如下:

一一第4章“组织要求”改为“组织和管理要求”，内容增加“组织和管理”、“文件和信息控制”、“申

请、投标和合同的评审”、服“务和供给的取得”、“用户反馈”、“不合格标准样品的控制”、“纠正

措施”、“预防措施”、“内部审核”、“管理评审”等有关规定，并将“环境”、“管理、人员和培训”、

材“料的处置和贮存”、“发放后的服务”等条，经调整列人第5章

—第5章“生产控制”改为“技术和生产要求”。

本部分的附录A是资料性附录。

本部分自实施之日起，代替GB/T15000.7-1997

本部分由全国标准样品技术委员会提出并归口。

本部分起草单位:全国标准样品技术委员会秘书处。

本部分主要起草人:陈柏年、高良才、张光伟、林卓然、伍千思、马岂和。

本部分1997年首次发布。

GB/'r15000.7-2001

ISO前言

ISO和IEC为世界范围标准化构成了专门体系。ISO或IEC成员的国家机构均通过参加技术委员

会的活动参与国际标准的制定，技术委员会由参加特定技术领域的有关组织组成。ISO和IEC技术委

员会在共同感兴趣的技术领域中合作。与ISO和IEC保持联系的其他国际组织(官方的和非官方的)也

可参加国际标准的制定。

指南是按ISO/IEC导则第3部分规则起草的。

由相应委员会或工作组负责的指南草案要分发给各国家机构投票表决，在得到至少75%的参加投

票的国家会员同意后，一个指南才能批准出版。

要注意:本指南的某些要素可能具有专利权，但ISO和IEC不负责确定这些专利权。

ISO指南34是ISO/REMCO制定的

本版发布后，1996年发布的第一版废止。本版是1996年版的修订版。

指南中附录A是资料性附录。

GB/T15000.7-2001

引言

标准样品的使用使得被“测量值”或“被赋予的量值”在检验、分析和测量实验室之间的传递成为可

能。标准样品被广泛应用于测量仪器的校准和测量方法的评定或确认。在有些情况下，采用标准样品可

以使特性很方便地以任意的单位表述。

随着标准样品生产者数量不断增加，为了确保标准样品的质量，当前对生产者的科学技术能力提供

证明成为一项基本要求。同时，在科学技术领域中由于测量仪器精密度的提高以及对更可靠准确数据的

需求，因而对新的、高质量标准样品的需求也日益增加。一些以前可接受的标准样品可能不再满足这些

更为严格的要求，所以标准样品生产者不仅需要以报告、证书和说明书的形式提供标准样品的信息，而

且还需要证明它有生产质量合格的标准样品的能力。

ISO指南34的1996年版规定了在标准样品生产中如何实施ISO/IEC指南25和ISO900。族标准

的解释，而对ISO/IEC指南25和ISO9000族标准中的一般要求没有列人。自从1996年发布ISO指南

34的第一版以来，情况的发展已经到了把对标准样品生产者的能力评定提到日程上来的程度。所以

2000年版本中规定了标准样品生产者必须证明其运行能够满足所有通用要求。

由药典主管机构建立和分发的药典标准和药物可遵循本标准的一般原则。但是应注意:药典主管机

构采用不同的方式向用户提供由分析证书和有效期给出的信息。而且，所赋予值的不确定度不用表述，

因为它同药典规定的专门分析方法确定的限值相比较可以忽略不计。

GB/T15000.7-2001

标准样品工作导则(7>

标准样品生产者能力的通用要求

范围

1.1GB/T1500。的本部分规定了标准样品生产者生产标准样品应有能力的通用要求。

1.2本部分适用于标准样品生产者建立、运行其质量体系，同时也适用于认可机构、认证机构以及其他

有关评定标准样品生产者能力的机构。

1.3本部分规定了标准样品生产应符合的质量体系要求，它应是标准样品生产者总的质量保证(QA)

程序的一个组成部分。

2规范性引用文件

下列文件中的条款通过GB/T15000的本部分的引用而成为本部分的条款。凡是注日期的引用文

件，其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本部分，然而，鼓励根据本部分达成

协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件，其最新版本适用于本

部分。

GB/T3935.1标准化和有关领域的通用术语第1部分:基本术语

GB/T19000质量管理体系基础和术语

GB/T15000.2标准样品工作导则(2)标准样品常用术语和定义

GB/T15000.3标准样品工作导则((3)标准样品定值的一般原则和统计方法

GB/T15000.4标准样品工作导则(4)标准样品证书内容的规定

GB/T15481校准和测试实验室能力的通用要求

GB/T19022.1测量设备的质量保证要求第1部分:测量设备的计量确认体系

VIM国际计量学通用的基础术语(由ISO,IEC,BIPM,IFCC,IUPAC,IUPAP和OIML发布)

术语和定义

GB/T3935.1,GB/T15481,GB/T15000.2,GB/T19000,VIM确立的以及如下术语和定义适用

于GB/T15000的本部分。

11

标准样品生产者referencematerialproducer

技术上有能力的机构(组织或公司，公营或私营)，它应对其按GB/T15000.3和GB/T15000.4生

产和供应的标准样品的标准值或其他特性值负全部责任。

3.2

合作者collaborator

技术上胜任的机构(组织或公司，公营或私营)，它以合同形式或自愿方式为标准样品生产者进行标

准样品(有证标准样品)的制作或测定工作。

GB/T15000.7-2001

4组织和管理要求

4.1质f体系要求

4.1.1总则

标准样品生产者应建立、实施和维持一个适合其工作范围的质量体系，包括承担生产的标准样品的

类型、范围和数量。

应当清楚地认识到:一个标准样品的测定主要是要达到其预期使用目的所要求的准确度水平(即合

适的测量不确定度)。标准样品生产者应规定一个确定材料质量的程序，并把该程序作为整个质量体系

的一个组成部分

标准样品生产者应根据标准样品的应用、测量方法(在均匀性、稳定性和测定研究中采用的)以及材

料基体的限制来规定它们的范围。

4.1.2质f方针

标准样品生产者应规定质量方针、目标和承诺，并形成文件以确保和维护标准样品生产的各个环节

的质量，包括材料质量(例如均匀性和稳定性)、测定(例如设备校准和测量方法的确认)、特性值的确定

(例如应用适当的统计程序)以及材料处理、贮存和运输程序。

必要时，质量方针应包括采用在各自测量领域具有活力和能力的实验室进行实验室间测定研究。因

此，该方针应包括承诺同测试技术界的