ISO9001:2015版條款

ISO9001:2026版條款

2026版新增要求

4   Context of the organization

4.1   Understanding the organization and its context

4.2   Understanding the needs and expectations of interested parties

4.3   Determining the scope of the quality management system

4.4   Quality management system and its processes

4   Context of the organization

4.1   Understanding the organization and its context

4.2   Understanding the needs and expectations of interested parties

4.3   Determining the scope of the quality management system

4.4   Quality management system

1，要求評估氣候變化對質量目標的影響；

2，要求組織持續(xù)監(jiān)視和評審其內外部環(huán)境，而不僅僅是一次性分析；

3，明確要考慮的因素需要更貼近時下的環(huán)境：如氣候變化、地緣政治局勢、技術顛覆等。

5   Leadership

5.1   Leadership and commitment

5.2   Policy

5.3   Organizational roles, responsibilities and authorities

5   Leadership

5.1   Leadership and commitment

5.2   Quality policy

5.3   Roles, responsibilities and authorities

1，新增要求最高管理者需確保QMS與組織戰(zhàn)略方向保持一致，并將質量管理體系整合到組織的業(yè)務流程中，領導者需直接參與體系建設，避免“責任轉嫁基層”。

2，要求最高管理者建立質量文化、制定道德準則，并保障遠程辦公技術設施；

3， 要求最高管理者不僅要滿足顧客要求，還要致力于增強顧客滿意和顧客忠誠。

6   Planning

6.1   Actions to address risks and opportunities

6.2   Quality objectives and planning to achieve them

6.3   Planning of changes

6   Planning

6.1   Actions to address risks and opportunities

6.2   Quality objectives and planning to achieve them

6.3   Planning of changes

1，要求將風險管理以及應急管理納入進來：風險應對（需制定供應鏈斷裂、技術故障等預案）；機遇管理（需建立新技術轉化流程，如AI質檢落地路徑）風險思維更具操作性。

2，要求措施的策劃與戰(zhàn)略目標聯(lián)系更緊密：風險和機遇的策劃需與組織的戰(zhàn)略方向保持一致。

7   Support

7.1   Resources

7.2   Competence

7.3   Awareness

7.4   Communication

7.5   Documented information

7   Support

7.1   Resources

7.2   Competence

7.3   Awareness

7.4   Communication

7.5   Documented information

1，對“組織知識”的管理要求更加明確，強調在變化中（如新員工、新過程、新市場）如何獲取和維護所需知識。

2，對文件的要求強調強調“可便捷調取”而非“形式化存檔”，明確允許云端存儲。

8   Operation

8.1   Operational planning and control

8.2   Requirements for products and services

8.3   Design and development of products and services

8.4   Control of externally provided processes, products and services

8.5   Production and service provision

8.6   Release of products and services

8.7   Control of nonconforming outputs

8   Operation

8.1   Operational planning and control

8.2   Requirements for products and services

8.3   Design and development of products and services

8.4   Control of externally provided processes, products and services

8.5   Production and service provision

8.6   Release of products and services

8.7   Control of nonconforming outputs

1，增加了對溝通處置或運輸后活動的要求。

2，澄清了在設計和開發(fā)策劃中需考慮網絡安全和產品可服務性等現(xiàn)代議題。

3，強調將供應鏈績效納入質量管理體系。

9   Performance evaluation

9.1   Monitoring, measurement, analysis and evaluation

9.2   Internal audit

9.3   Management review

9 Performance   evaluation

9.1 Monitoring,   measurement, analysis and evaluation

9.2 Internal   audit

9.3 Management   review

1，要求分析顧客滿意度的趨勢，而不僅僅是獲取信息。

2，明確納入社交媒體（如微博、抖音評論）、網站留言、在線客服記錄等新型數(shù)據(jù)源作為顧客反饋的依據(jù)

10   Improvement

10.1   General

10.2   Nonconformity and corrective action

10.3   Continual improvement

10   Improvement

10.1   Continual improvement

10.2   Nonconformity and corrective action

1，更加強調持續(xù)改進

2，新增“學習與創(chuàng)新”，鼓勵組織將改進過程中的經驗教訓轉化為知識（學習），并探索新的機會和方法（創(chuàng)新），從而推動突破性改進和戰(zhàn)略發(fā)展。