10.2.1、当出现不合格时，包括来自投诉的不合格，组织应：

a）对不合格做出应对，并在适用时：

1）采取措施以控制和纠正不合格；

2）处置后果。

b）通过下列活动，评价是否需要采取措施，以消除产生不合格的原因，避免其再次发生或者在其他场合发生：

1）评审和分析不合格；

2）确定不合格的原因,必要时，包括人为因素；

3）确定是否存在或可能发生类似的不合格。

c）实施所需的措施；

d）评审所采取的纠正措施的有效性；

e）需要时，更新策划期间确定的风险和机遇；

f）需要时，变更质量管理体系。

g）当确定是外部供方对不符合负责时，向外部供方传递纠正措施的要求；

h）当不能及时和有效地采取纠正措施时,需采取特定措施。

纠正措施应与不合格所产生的影响相适应。

组织应维持规定管理不合格和纠正措施过程的成文信息。

10.2.2、组织应保留成文信息，作为下列事项的证据：

a）不合格的性质以及随后所采取的措施；

b）纠正措施的结果。

10.2.1、When a nonconformity occurs, including any arising from complaints, the organization shall:

a. react to the nonconformity and, as applicable:

1.take action to control and correct it;

2. deal with the consequences;

b. evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:

1.reviewing and analyzing the nonconformity;determining the causes of the nonconformity,

2.including those related to human factors, as applicable;

3.determining if similar nonconformities exist, or could potentially occur;

c. implement any action needed;

d. review the effectiveness of any corrective action taken;

e. update risks and opportunities determined during planning, if necessary;

a. make changes to the quality management system, if necessary;

g. flow down corrective action requirements to an external provider when it is determined that the external provider is responsible for the nonconformity;

h. take specific actions when timely and effective corrective actions are not achieved.

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

The organization shall maintain documented information that defines the nonconformity and corrective action management processes.

10.2.2、The organization shall retain documented information as evidence of:

a. the nature of the nonconformities and any subsequent actions taken;

b. the results of any corrective action.