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ISO13485认证辅导---ISO13485-2016中英文对照 测量、分析和改进(8.3)

日期:2018-05-01 11:43:05 来源:本站原创   【字体:

8.3 Controlof nonconforming product 不合格品的控制

 

8.3.1 General 总则

 

The organizationshall ensure that product which does not conform to product requirements is identifiedand controlled to prevent its unintended use or delivery. The organizationshall document a procedure to define the controls and related responsibilitiesand authorities for the identification, documentation, segregation, evaluationand disposition of nonconforming product.

组织应确保标识和控制不符合产品要求的产品从而阻止非预期的使用和交付。组织应当建立一个程序来明确用于控制以及界定、记录、控制、隔离、评估(新增)、处置不合格品相应的职责和权限。

 

The evaluation of nonconformityshall include a determination of the need for an investigation and notificationof any external party responsible for the nonconformity.

不合格品的评估应包括明确的用于检查的需求,并针对不合格尽责的向外部进行告知。(新增)

 

Records of thenature of the nonconformities and any subsequent action taken, including theevaluation, any investigation and the rationale for decisions shall bemaintained (see 4.2.5)

不合品的性质以及任何后续措施的相关记录(包括评估、任何检查和决定的理由)都应当予以保留。(见4.2.5)

 

8.3.2 Actions in response to nonconforming product detected before delivery 放行前不合格品的处置

 

The organizationshall deal with nonconforming product by one or more of the following ways:

组织应当通过以下一种或多种方式处理不合格品:

 

a) taking actionto eliminate the detected nonconformity;

采取措施以消除所发现的不合格;

 

b) taking actionto preclude its original intended use or application;

采取措施以阻止其原预期的使用或应用。

 

c) authorizingits use, release or acceptance under concession.

批准其让步使用、放行或接收。

 

The organizationshall ensure that nonconforming product is accepted by concession only if the justificationis provided, approval is obtained and applicable regulatory requirements aremet. Records of the acceptance by concession and the identity of the personauthorizing the concession shall be maintained (see 4.2.5).

组织应当确保只有当能够提供正当理由、获得批准和符合相应法律法规要求的前提下,不合格产品才可以让步接收。

 

8.3.3 Actions in response to nonconforming product detected after delivery

放行后不合格品的处置

 

Whennonconforming product is detected after delivery or use has started, theorganization shall take action appropriate to the effects, or potentialeffects, of the nonconformity. Records of actions taken shall be maintained(see 4.2.5).

当在销售和开始后发现了不合格品,组织应当采取与影响或潜在影响相适应的不合品处理措施。处理措施的相关记录应当予以保留。(见4.2.5)(新增)

 

The organizationshall document procedures for issuing advisory notices in accordance withapplicable regulatory requirements. These procedures shall be capable of beingput into effect at any time. Records of actions relating to the issuance ofadvisory notices shall be maintained (see 4.2.5).

组织应当建立依据相应法律法规要求发出忠告性通知的程序。这些程序应当在任何时候都能得以实施。与发布忠告性通知有关的措施的记录应当予以保留。(见4.2.5)(新增)

 

8.3.4 Rework 返工

 

The organizationshall perform rework in accordance with documented procedures that takes into accountthe potential adverse effect of the rework on the product. These procedures shallundergo the same review and approval as the original procedure.

After thecompletion of rework, product shall be verified to ensure that it meetsapplicable acceptance criteria and regulatory requirements.

组织应当按照事先规定好的文件化的充分考虑了产品返工的潜在不利影响的程序进行返工。这些程序应当与原始程序一样经过审核和批准。返工完成后,应当对产品进行验证以保证产品符合可接受标准和法律法规要求。

 

Records ofrework shall be maintained (see 4.2.5).

返工记录应予以保留。(见4.2.5

上一篇:ISO13485认证辅导---ISO13485-2016中英文对照 测量、分析和改进(8.2.1~8.2.6) 下一篇:ISO13485认证辅导---ISO13485-2016中英文对照 测量、分析和改进(8.4)
 
 

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