GB/T 19027-2025 质量管理 GB/T 19001-2016的统计技术指南

ICS03.120.10

CCSA00

中华人民共和国国家标准

GB/T19027—2025/ISO10017:2021

代替GB/Z19027—2005

质量管理GB/T19001—2016的统计

技术指南

Qualitymanagement—

GuidanceonstatisticaltechniquesforGB/T19001—2016

（ISO10017：2021，IDT）

2025⁃05⁃30发布2025⁃05⁃30实施

国家市场监督管理总局

国家标准化管理委员会发布

GB/T19027—2025/ISO10017:2021

目次

前言··························································································································Ⅲ

引言··························································································································Ⅳ

1范围·······················································································································1

2规范性引用文件········································································································1

3术语和定义··············································································································1

4GB/T19001实施中的统计技术····················································································1

5GB/T19001—2016中的定量数据和相关统计技术····························································2

6选定统计技术的适用性·······························································································8

7统计技术说明···········································································································8

7.1描述性统计········································································································8

7.1.1一般说明······································································································8

7.1.2益处··········································································································10

7.1.3局限性与注意事项························································································10

7.1.4应用示例····································································································11

7.2实验设计··········································································································11

7.2.1一般说明····································································································11

7.2.2益处··········································································································11

7.2.3局限性与注意事项························································································11

7.2.4应用示例····································································································12

7.3假设检验··········································································································12

7.3.1一般说明····································································································12

7.3.2益处··········································································································12

7.3.3局限性与注意事项························································································12

7.3.4应用示例····································································································12

7.4测量系统分析····································································································13

7.4.1一般说明····································································································13

7.4.2益处··········································································································13

7.4.3局限性与注意事项························································································13

7.4.4应用示例····································································································13

7.5过程能力分析····································································································14

7.5.1一般说明····································································································14

7.5.2益处··········································································································14

7.5.3局限性与注意事项························································································14

Ⅰ

GB/T19027—2025/ISO10017:2021

7.5.4应用示例····································································································15

7.6回归分析··········································································································15

7.6.1一般说明····································································································15

7.6.2益处··········································································································16

7.6.3局限性与注意事项························································································16

7.6.4应用示例····································································································16

7.7可靠性分析·······································································································16

7.7.1一般说明····································································································16

7.7.2益处··········································································································17

7.7.3局限性与注意事项························································································17

7.7.4应用示例····································································································17

7.8抽样················································································································18

7.8.1一般说明····································································································18

7.8.2益处··········································································································18

7.8.3局限性与注意事项························································································18

7.8.4应用示例····································································································18

7.9模拟················································································································19

7.9.1一般说明····································································································19

7.9.2益处··········································································································19

7.9.3局限性与注意事项························································································19

7.9.4应用示例····································································································19

7.10统计过程控制··································································································19

7.10.1一般说明···································································································19

7.10.2益处·········································································································20

7.10.3局限性与注意事项·······················································································20

7.10.4应用示例···································································································21

7.11统计容差法·····································································································21

7.11.1一般说明···································································································21

7.11.2益处·········································································································21

7.11.3局限性与注意事项·······················································································21

7.11.4应用示例···································································································22

7.12时间序列分析··································································································22

7.12.1一般说明···································································································22

7.12.2益处·········································································································23

7.12.3局限性与注意事项·······················································································23

7.12.4应用示例···································································································23

参考文献····················································································································24

Ⅱ

GB/T19027—2025/ISO10017:2021

前言

本文件按照GB/T1.1—2020《标准化工作导则第1部分：标准化文件的结构和起草规则》的规

定起草。

本文件代替GB/Z19027—2005《GB/T19001—2000的统计技术指南》，与GB/Z19027—2005相

比，除结构调整和编辑性改动外，主要技术变化如下：

——更改了标准的适用范围（见第1章，2005年版的第1章）；

——增加了术语和定义（见第3章）；

——更改了在GB/T19001—2016各条款的相关活动中可能会涉及的定量数据（见表1，2005年

版表1）；

——更改了选定统计技术的适用性说明（见第6章，2005年版的第4章）；

——更改了每种统计技术的相关技术要求（见第7章，2005年版的第4章）。

本文件等同采用ISO10017:2021《质量管理ISO9001:2015的统计技术指南》。

请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。

本文件由全国质量管理和质量保证标准化技术委员会（SAC/TC151）提出并归口。

本文件起草单位：中国标准化研究院、上海市质量协会、北新集团建材股份有限公司、海信集团控

股股份有限公司、潍柴动力股份有限公司、扬子江药业集团有限公司、山东景阳冈酒厂有限公司、华夏

认证中心有限公司、北京军友诚信检测认证有限公司、中创新海（天津）认证服务有限公司、电能（北京）

认证中心有限公司、中联认证中心（北京）有限公司、江西省质量和标准化研究院、云账户技术（天津）

有限公司。

本文件主要起草人：段琦、刘中华、高峰、郭建军、赵传新、石二奎、冀润景、殷红、虞积安、尹慧琼、

周育清、丛德政、周学礼、杨晖、亢国存、张婧姝。

本文件及其所代替文件的历次版本发布情况为：

——2001年首次发布为GB/Z19027—2001，2005年第一次修订；

——本次为第二次修订。

Ⅲ

GB/T19027—2025/ISO10017:2021

引言

众所周知，在所有过程与活动的执行实施和结果中都存在着固有的变异，甚至在明显稳定的状况

下也是如此。在产品的整个生命周期、过程的可量化特性以及最终产品和服务中，都能观察到变异。

统计技术有助于变异的测量、描述、分析、解释和建模（无论是处理相对有限的数据还是大型数据

集）。对数据的统计分析能更好地理解变异的性质、程度和原因，从而帮助解决甚至预防由这些变异可

能引发的问题，并降低由这些变异可能带来的风险。

使用统计技术分析数据可以帮助做出决策，因而有助于提高过程和最终输出的绩效。统计技术适

用于各行各业的数据，具有潜在的有益结果。

确定统计技术需求的准则以及所选择的统计技术是否适宜，由组织做出最终决定。

本文件旨在帮助组织根据GB/T19001—2016所定义的质量管理体系要素，识别统计技术。应用

这些统计技术能在质量、生产力和成本方面产生一定的收益。

本文件也可用于支持其他管理体系（如环境管理体系、职业健康安全管理体系）及其支持性标准。

Ⅳ

GB/T19027—2025/ISO10017:2021

质量管理GB/T19001—2016的统计

技术指南

1范围

本文件提供了选择适宜的统计技术的指南，与组织规模或复杂性无关。这些技术对组织开发、实

施、保持和改进符合GB/T19001—2016要求的质量管理体系能有用。

本文件不提供如何使用这些统计技术的指南。

2规范性引用文件

下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注日期的引用文

件，仅该日期对应的版本适用于本文件；不注日期的引用文件，其最新版本（包括所有的修改单）适用于

本文件。

GB/T19000-2016质量管理体系基础和术语（ISO9000:2015，IDT）

ISO3534⁃1统计学词汇及符号第1部分：一般统计术语与用于概率的术语（Statistics—Vo⁃

cabularyandsymbols—Part1:Generalstatisticaltermsandtermsusedinprobability）

ISO3534⁃2统计学词汇及符号第2部分：应用统计（Statistics—Vocabularyandsymbols—

Part2:Appliedstatistics）

ISO3534⁃3统计学词汇及符号第3部分：实验设计（Statistics—Vocabularyandsymbols—

Part3:Designofexperiments）

ISO3534⁃4统计学词汇及符号第4部分：调查抽样（Statistics—Vocabularyandsymbols—

Part4:Surveysampling）

3术语和定义

GB/T19000—2016、ISO3534⁃1、ISO3534⁃2、ISO3534⁃3、ISO3534⁃4界定的以及下列术语和定

义适用于本文件。

3.1

统计技术statisticaltechnique

统计方法statisticalmethod

与研究的产品、过程、服务和现象的变异相关的定量数据的分析方法，以提供关于研究对象的

信息。

注：如果定性（非数字）数据能转换为定量（数字）数据，统计技术同样适用于这种数据。

4GB/T19001实施中的统计技术

统计技术有助于评价、控制、改进过程及其输出，以及评价和提高质量管理体系的有效性。

已经广泛使用且在GB/T19001实施中得到有益应用的统计技术或统计技术系列，包括：

——描述性统计（见7.1）；

1

GB/T19027—2025/ISO10017:2021

——实验设计（DOE）（见7.2）；

——假设检验（见7.3）；

——测量系统分析（MSA）（见7.4）；

——过程能力分析（见7.5）；

——回归分析（见7.6）；

——可靠性分析（见7.7）；

——抽样（见7.8）；

——模拟（见7.9）；

——统计过程控制（SPC）（见7.10）；

——统计容差法（见7.11）；

——时间序列分析（见7.12）。

其中一些技术能与其他技术结合使用，或作为其他统计技术的子集使用。

本文件给出的统计技术既不全面也不详尽，不应排除使用被认为对组织有益的任何其他技术（统

计技术或其他技术）。本文件不拟规定宜使用哪些统计技术，也不对如何实施这些统计技术提出建议。

5GB/T19001—2016中的定量数据和相关统计技术

表1给出了在GB/T19001—2016各条款的相关活动中可能会涉及的定量数据。对应已识别的

定量数据给出的是使用这些数据时，可能对组织具有潜在益处的统计技术。

如果定量数据不易与GB/T19001—2016条款相关联，则未能识别出统计技术。

本文件给出的统计技术仅限于众所周知的技术。每种统计技术的简要说明见第7章。

组织能对表1给出的各统计技术的相关性和价值开展评价，并确定其是否适用于该条款。

表1定量数据和可能的统计技术

GB/T19001—2016的条款涉及的定量数据统计技术

1.范围不适用—

2.规范性引用文件不适用—

3.术语和定义不适用—

4.组织环境

有关内外部因素的数据，例如:

——财务

——员工调查描述性统计

——市场调查统计过程控制

4.1理解组织及其环境

——销售抽样

——产品和服务绩效时间序列分析

——竞争/标杆比对

——顾客调查

描述性统计

有关相关方期望的主观和客观数据（如市

4.2理解相关方的需求和期望抽样

场调查、顾客调查、员工调查）

时间序列分析

4.3确定质量管理体系的范围未识别出定量数据—

4.4质量管理体系及其过程

2

GB/T19027—2025/ISO10017:2021

表1定量数据和可能的统计技术（续）

GB/T19001—2016的条款涉及的定量数据统计技术

4.4.1未识别出定量数据—

4.4.2未识别出定量数据—

5.领导作用

5.1领导作用和承诺

5.1.1总则未识别出定量数据—

5.1.2以顾客为关注焦点未识别出定量数据—

5.2方针

5.2.1制定质量方针未识别出定量数据—

描述性统计

5.2.2沟通质量方针确定对质量方针理解程度的数据

抽样

5.3组织的岗位、职责和权限未识别出定量数据—

6策划

6.1应对风险和机遇的措施

6.1.1评估风险的业务数据描述性统计

6.1.2评估所采取措施有效性的业务数据描述性统计

6.2质量目标及其实现的策划

6.2.1有助于建立质量目标的历史绩效数据—

6.2.2有助于建立质量目标的历史绩效数据—

6.3变更的策划有助于建立质量目标的历史绩效数据—

7支持

7.1资源

7.1.1总则与能力相关的汇总数据描述性统计

7.1.2人员未识别出定量数据—

描述性统计

与设备（硬件和软件）和运输的性能和可

7.1.3基础设施过程能力分析

靠性相关的定量数据