EN ISO 9000 2026 Quality management-Fundamentals and vocabulary
VIP免费
BSENISO9000:2026
EUROPEAN STANDARD
NORMEEUROPÉENNE
EUROPÄISCHE NORM
EN ISO9000
May 2026
ICS 01.040.03;03.120.10;03.100.70 Supersedes EN ISO 9000:2015
English Version
Quality management-Fundamentals and vocabulary (ISO
9000:2026)
Management de la qualité-Principes essentiels et
vocabulaire(ISO 9000:2026)
Qualitätsmanagement - Grundlagen und Begriffe (ISO
9000:2026)
This European Standard was approved by CEN on 14 May 2026.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration.Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English,French,German).A version in any other language made by
translation under the responsibility ofaCENmember into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies ofAustria,Belgium,Bulgaria,Croatia,Cyprus,Czech Republic,Denmark,Estonia,
Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,
Poland,Portugal,Republic ofNorth Macedonia,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,Türkiye and
United Kingdom.
EUROPEAN COMMITTEEFOR STANDARDIZATION
COMITÉ EUROPÉENDE NORMALISATION
EUROPÄISCHESKOMITEEFÜRNORMUNG
CEN-CENELEC Management Centre:Rue de la Science 23,B-1040 Brussels
2026 CEN Allrights of exploitation in any form and by any means reserved Ref.No.EN ISO 9000:2026E
worldwide for CEN national Members.
EN ISO 9000:2026(E)
European foreword
This document (EN ISO 9000:2026)has been prepared by Technical Committee ISO/TC176 "Quality
management and quality assurance"in collaboration with CCMC.
This European Standard shall be given the status of a national standard,either by publication of an
identical text or by endorsement,at the latest by November 2026,and conflicting national standards
shall be withdrawn at the latest by November 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights.CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 9000:2015.
This document has been prepared under a standardization request addressed to CEN by the European
Commission.The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
Any feedback and questions on this document should be directed to the users'national standards
body/national committee.A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations,the national standards organizations of the
following countries are bound to implement this European Standard:Austria,Belgium,Bulgaria,
Croatia,Cyprus,Czech Republic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,
Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta, Netherlands,Norway, Poland,Portugal,Republic of
North Macedonia,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO9000:2026 has been approved by CEN as EN ISO 9000:2026without any modification.
iii
ISO 9000:2026(en)
Contents Page
Foreword....................................................................................................................................................... V
Introduction................................................................................................................................................ Vi
1 Scope
................................................................................................................................................... 1
2 Normative references ....................................................................................................................... 1
3 Terms and definitions...................................................................................................................... 1
3.1 Terms related to organization.................................................................................................. 1
3.2 Terms related to managemen..................................................................................................... 3
3.3 Terms related to proces............................................................................................................5
3.4 Terms related to system.......................................................................................................... 7
3.5 Terms related to requiremen..................................................................................................... 9
3.6 Terms related to action........................................................................................................... 10
3.7 Terms related to result........................................................................................................... 12
3.8 Terms related to data, information and documents............................................................... 15
3.9 Terms related to customer...................................................................................................... 17
3.10 Terms related to characteristic............................................................................................... 19
3.11 Terms related to determination...............................................................................................20
3.12 Terms related to audi............................................................................................................ 22
4Fundamentals of quality management ....................................................................................... 24
4.1 Genera ................................................................................................................................... 24
4.2Quality management princip...les……………………………………………………………………25
4.2.1 General....................................................................................................................... 25
4.2.2 Customer focus........................................................................................................... 25
4.2.3 Leadership...................................................................................................................26
4.2.4 Engagement of people.................................................................................................. 26
4.2.5 Process approach........................................................................................................27
4.2.6 Improvement................................................................................................................28
4.2.7 Evidence-based decision-making............................................................................... 29
4.2.8 Relationship managemen........................................................................................... 29
4.3 Fundamental quality management concepts........................................................................... 30
4.3.1 Quality....................................................................................................................... 30
4.3.2 Quality management....................................................................................................30
4.3.3 Quality management system (QMS..............................................................................31
4.3.4 Quality assurance....................................................................................................... 31
4.3.5 Quality contro............................................................................................................. 31
4.3.6 Quality planning...........................................................................................................32
4.3.7 Process management................................................................................................... 32
4.3.8 Risk-based thinking................................................................................................... 32
4.3.9 Organizational quality culture ................................................................................... 32
4.3.10 Continual improvemen............................................................................................. 33
4.4 Additional concepts relevant to quality managemen............................................................ 33
4.4.1 Context of an organization.........................................................................................33
4.4.2 Interested parties..................................................................................................... 33
4.4.3 Integrated management system................................................................................ 33
4.4.4 Circular economy........................................................................................................34
4.4.5 Emerging technologies............................................................................................... 34
4.4.6 Innovation.................................................................................................................... 34
4.4.7 Change managemen......................................................................................................35
4.4.8 Customer experience.................................................................................................. 35
4.4.9 Knowledge managemen..............................................................................................35
4.4.10 Information management........................................................................................... 36
4.4.11 People aspects ........................................................................................................... 36
4.4.12 Business continuity......................................................................................................36
4.5 Developing a QMS using fundamental concepts and principles............................................... 37
4.5.1 Attributes of a QM....................................................................................................... 37
◎ISO 2026-All rights reserved
摘要:
展开>>
收起<<
BSENISO9000:2026EUROPEANSTANDARDNORMEEUROPÉENNEEUROPÄISCHENORMENISO9000May2026ICS01.040.03;03.120.10;03.100.70SupersedesENISO9000:2015EnglishVersionQualitymanagement-Fundamentalsandvocabulary(ISO9000:2026)Managementdelaqualité-Principesessentielsetvocabulaire(ISO9000:2026)Qualitätsmanagement-Grundla...
声明:如果您的权利被侵害,请联系我们的进行举报。
相关推荐
-
医疗器械设计开发控制指南VIP免费
2024-04-12 383 -
YY∕T 0664-2020医疗器械软件软件生存周期过程核查表VIP免费
2024-04-12 411 -
创新医疗器械注册申报流程
2024-05-02 203 -
20221028_医疗器械生产现场核查缺陷分析交流(江苏药省监局审核查验中心) (1)VIP免费
2024-05-09 156 -
医疗器械网络安全漏洞自评报告VIP专享
2024-11-18 376 -
内审检查表 MDR法规VIP免费
2025-04-07 381 -
核查中心2025年第一批医疗器械飞行检查情况汇总.pdfVIP免费
2025-05-27 176 -
特定上市前提交审查的质量管理体系信息-2025草案_中英文版VIP专享
2025-11-03 104 -
医疗器械生产企业质量管理体系程序文件模板全套VIP免费
2026-05-11 47 -
医疗器械质量管理体系-质量手册-2026(国家局2025第107号)VIP专享
2026-06-04 149
作者:大傻蛋
分类:法规规范
价格:200质量币
属性:62 页
大小:1.05MB
格式:PDF
时间:2026-06-14

