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(píng)估氣候變化對(duì)質(zhì)量目標(biāo)的影響；

2，要求組織持續(xù)監(jiān)視和評(píng)審其內(nèi)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(shí)下的環(huán)境：如氣候變化、地緣政治局勢(shì)、技術(shù)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(zhì)量管理體系整合到組織的業(yè)務(wù)流程中，領(lǐng)導(dǎo)者需直接參與體系建設(shè)，避免“責(zé)任轉(zhuǎn)嫁基層”。

2，要求最高管理者建立質(zhì)量文化、制定道德準(zhǔn)則，并保障遠(yuǎn)程辦公技術(shù)設(shè)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(qiáng)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(fēng)險(xiǎn)管理以及應(yīng)急管理納入進(jìn)來：風(fēng)險(xiǎn)應(yīng)對(duì)（需制定供應(yīng)鏈斷裂、技術(shù)故障等預(yù)案）；機(jī)遇管理（需建立新技術(shù)轉(zhuǎn)化流程，如AI質(zhì)檢落地路徑）風(fēng)險(xiǎn)思維更具操作性。

2，要求措施的策劃與戰(zhàn)略目標(biāo)聯(lián)系更緊密：風(fēng)險(xiǎn)和機(jī)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(duì)“組織知識(shí)”的管理要求更加明確，強(qiáng)調(diào)在變化中（如新員工、新過程、新市場(chǎng)）如何獲取和維護(hù)所需知識(shí)。

2，對(duì)文件的要求強(qiáng)調(diào)強(qiáng)調(diào)“可便捷調(diào)取”而非“形式化存檔”，明確允許云端存儲(chǔ)。

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(duì)溝通處置或運(yùn)輸后活動(dòng)的要求。

2，澄清了在設(shè)計(jì)和開發(fā)策劃中需考慮網(wǎng)絡(luò)安全和產(chǎn)品可服務(wù)性等現(xiàn)代議題。

3，強(qiáng)調(diào)將供應(yīng)鏈績(jī)效納入質(zhì)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(shì)，而不僅僅是獲取信息。

2，明確納入社交媒體（如微博、抖音評(píng)論）、網(wǎng)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(qiáng)調(diào)持續(xù)改進(jìn)

2，新增“學(xué)習(xí)與創(chuàng)新”，鼓勵(lì)組織將改進(jìn)過程中的經(jīng)驗(yàn)教訓(xùn)轉(zhuǎn)化為知識(shí)（學(xué)習(xí)），并探索新的機(jī)會(huì)和方法（創(chuàng)新），從而推動(dòng)突破性改進(jìn)和戰(zhàn)略發(fā)展。