ISO 9001:2026 已正式发布，2015 版证书需在 2029 年 9 月 30 日前完成转版。这一版容易被低估的第一处硬变化：质量文化与道德行为，写进要求了。
▌ 条款 5.1.1 领导作用
变化点：
- 新增 i)：推动相适应的质量文化与道德行为；
- 新增 k)：基于风险和机遇的思维；
- 新增注 2：质量文化 = 共同的价值观、态度、惯例和行动。
要做的事：
- 管理评审增加质量文化议题，由高层汇报举措；
- 把文化要求写进制度和岗位职责。
▌ 条款 7.3 / 7.1.4 意识与环境
变化点：
- 7.3 新增 e)：员工知晓质量文化与道德行为及其贡献；
- 7.1.4 新增注：社会、心理、激励因素可能受文化影响。
要做的事：
- 全员宣贯培训，签到、课件、考核留痕；
- 环境识别表补充文化类因素（例如"隐瞒不良的氛围"）。
▌ 要动的文件清单
- 质量手册 5.1 章节、岗位职责说明；
- 管理评审输入清单；
- 培训计划、入职教材、意识培训记录；
- 过程运行环境识别表。
记一句：文化补不了文件，只能补日常。
续创做转版辅导时反复强调：文化不是墙上的标语，而是审核员访谈一线员工时感受到的东西。
需要 ISO 9001:2026 转版差距分析与落地辅导？欢迎联系续创信息技术咨询。
ISO 9001:2026 has been published, and 2015 certificates must complete transition by 30 September 2029. The first hard change in this edition is also the easiest to underestimate: quality culture and ethical behaviour are now requirements.
▌ Clause 5.1.1 Leadership
What changed:
- New item i): promoting a suitable quality culture and ethical behaviour;
- New item k): a risk-and-opportunity-based mindset;
- New Note 2: quality culture = shared values, attitudes, practices and actions.
What to do:
- Add quality culture to the management review agenda, with top management reporting actions;
- Write culture requirements into procedures and job responsibilities.
▌ Clauses 7.3 / 7.1.4 Awareness and environment
What changed:
- 7.3 adds e): personnel are aware of quality culture and ethical behaviour and their contribution;
- 7.1.4 adds a note: social, psychological and motivational factors can be influenced by culture.
What to do:
- Run awareness training for everyone, keeping sign-in sheets, slides and assessment records;
- Add culture-related factors (for example, an atmosphere that hides nonconformities) to the process environment register.
▌ Documents to update
- Quality manual clause 5.1, job responsibility descriptions;
- Management review input list;
- Training plan, onboarding material, awareness training records;
- Process operating environment register.
One line to remember: culture cannot be fixed with documents, only with daily practice.
Xuchuang stresses this throughout transition support: culture is not a slogan on the wall — it is what an auditor feels when interviewing people on the shop floor.
Need a gap analysis and hands-on support for the ISO 9001:2026 transition? Talk to Xuchuang Information Technology Consulting.