The main changes being introduced into the new standard are as follows:
新标准的主要变化之处如下：

Clause 0.2 (Process approach)
0.2条款 (过程方法)
Text added to emphasize the importance of processes being capable of achieving desired outputs
增加了条文，以强调有能力实现期望输出的过程的重要性。
Clause 1.1 (Scope)
1.1条款 (范围)
Clarification that “product” also includes intermediate product
阐明了“产品”也包括中间产品
Explanation regarding statutory, regulatory and legal requirements
关于法律法规要求的说明
Clause 4.1 (General requirements)
4.1条款 (总要求)
Notes added to explain more about outsourcing
增加了注解， 以对外包进一步加以说明
Types of control that may be applied to outsourced processes
可应用于对外包过程的控制方式的类型
Relationship to clause 7.4 (Purchasing)
与7.4 条款（采购）的关系
Clarification that outsourced processes are still responsibility of the organization and must be
included in the quality management system
阐明外包过程仍然是组织的责任，必须被包括在质量管理体系中
Clause 4.2.1 (Documentation)
4.2.1 条款 (文件)
Clarification that QMS documentation also includes records
阐明QMS文件也包括记录
Documents required by the standard may be combined
本标准所要求的文件可以进行整合
ISO 9001 requirements may be covered by more than one documented procedure
ISO 9001 要求可被一个以上形成文件的程序所覆盖

Clause 4.2.3 (Document control)
4.2.3 条款 (文件控制)
Clarification that only external documents relevant to the QMS need to be controlled
阐明只需对与QMS 有关的外来文件加以控制

Clause 4.2.4 (Records control)

4.2.4 条款 (记录控制)
Editorial changes only (better alignment with ISO 14001)
只是文字表述上的变化（以与ISO 14001 衔接得更好）


Clause 5.5.2 (Management rep)
5.5.2 条款 (管理者代表)
Clarifies that this must be a member of the organization’s own management
阐明管理者代表必须是组织自身管理层的一员

Clause 6.2.1 (Human resources)
6.2.1 条