9.2.1、组织应按照策划的时间间隔进行内部审核，以提供有关质量管理体系的下列信息：

a）是否符合：

1）组织自身的质量管理体系要求；

注：组织自身要求包括顾客、法律法规以及监管对质量管理体系的要求。

2）本标准的要求。

b）是否得到有效的实施和保持。

注：进行内部审核时，可以通过评价绩效指标来判定质量管理体系是否得到有效的实施和维护。

9.2.2、组织应：

a）依据有关过程的重要性、对组织产生影响的变化和以往的审核结果，策划、制定、实施和保持审核方案，审核方案包括频次、方法、职责、策划要求和报告；

b）规定每次审核的审核准则和范围；

c）选择审核员并实施审核，以确保审核过程客观公正；

d）确保将审核结果报告给相关管理者；

e）及时采取适当的纠正和纠正措施；

f）保留成文信息，作为实施审核方案以及审核结果的证据。

注：相关指南参见ISO 19011。

9.2.1、The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system;

a. conforms to:

1.the organization’s own requirements for its quality management system;

NOTE: The organization’s own requirements should include customer and applicable statutory and regulatory quality management system requirements.

2. the requirements of this International Standard;

b. is effectively implemented and maintained.

NOTE: When conducting internal audits, performance indicators can be evaluated to determine whether the quality management system is effectively implemented and maintained.

9.2.2、The organization shall:

a. plan, establish, implement, and maintain an audit program(s) including the frequency, methods, responsibilities, planning requirements, and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits;

b. define the audit criteria and scope for each audit;

c. select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;

d. ensure that the results of the audits are reported to relevant management;

e. take appropriate correction and corrective actions without undue delay;

f. retain documented information as evidence of the implementation of the audit program and the audit results.

NOTE: See ISO 19011 for guidance.