The Manual is prepared by the Quality Dept. reviewed by Management Representative and subject to approval from the General Manager.

手册由质量部组织编写,管理者代表审核,总经理批准。

属类：应用文体-质量手册-实例

This manual is either issued as controlled copy or uncontrolled copy, and identified on the cover page of the manual.

手册分受控版本和非受控版本,发放时须标注“受控”“非受控”。

属类：应用文体-质量手册-实例

The controlled copy shall be numbered, and if revised, the holder of this manual shall be notified and have a copy of new revision promptly.

受控版本进行编号登记,受控版本的持有者可得到最新版本.

属类：应用文体-质量手册-实例

The uncontrolled copy is allowed to be revised without notifying the holder and could be discarded.

不受控版本修改时不通知手册持有者,作废无须收回。

属类：应用文体-质量手册-实例

Quality Dept. is assigned for the controlling of Manual. The Administrative Office is responsible for registration and circulation of Manual.

质量部为手册归口管理部门,办公室负责统一登记、发放.

属类：应用文体-质量手册-实例

The Manual shall be numbered according to Document Control Procedure. The Management Representative is responsible for the interpretation of this Manual.

手册编号按《文件控制程序》执行,管理者代表负责对本手册解释。

属类：应用文体-质量手册-实例

Any suggestions for a change in the Manual shall be collected and feedback to the Quality Dept. promptly.

手册使用期间如有修改建议,各部门负责人应汇总意见,及时反馈到质量部.

属类：应用文体-质量手册-实例

An updated version may be necessary when a lot of revisions or some significant changes occur or the quality management standard has been revised.

当质量手册经过重大或多次修改以及质量管理标准新修订后,公司应根据情况适时进行换版。

属类：应用文体-质量手册-实例

After the issue of new version, the old version shall become annulled and recycled.

新版本颁发,旧版本即行终止并及时收回。

属类：应用文体-质量手册-实例

The change of Manual shall be conducted in accordance with Document Control Procedure.

手册的修改按《文件控制程序》执行。

属类：应用文体-质量手册-实例

The company reviews the Quality Manual by conducting management reviews annually to confirm its conformance, effectiveness and suitability.

公司每年通过管理评审对质量手册进行评审,验证其符合性、有效性和适宜性。

属类：应用文体-质量手册-实例

By the end of 2003, the company has established and improved our quality assurance system in accordance with YY/T0287-2003 in order to further better our quality management capability.

为提高质量管理水平,公司在原有管理的基础上,于2003年底按YY/T0287-2003标准要求的模式,建立健全本公司的质量保证体系。

属类：应用文体-质量手册-实例

Applicable for the establishment of quality management system of disposable sterilized medical devices and the external quality commitment.

适用于本公司一次性使用无菌医疗器械质量管理体系的建立和对外的质量保证。

属类：应用文体-质量手册-实例

This Manual covers disposable intravenous injection needle

本手册覆盖的产品包括一次性使用静脉输液针.

属类：应用文体-质量手册-实例

Section 7.5.4 in the Standard is not necessary for this Manual because the customers provide none of our products.

因本公司生产上述产品不涉及到顾客提供产品,故对标准7.5.4进行删除。

属类：应用文体-质量手册-实例

The following standards contain provisions, which, through reference in this text, constitute provisions of this manual.

下列标准和法规所包含的条文,通过在本手册中引用而构成本手册的条文。

属类：应用文体-质量手册-实例

At time of publication, the editions indicated were valid. All standards are subject to revision.

本手册发布时,所示版本均为有效,所有标准和法规都会被修订。

属类：应用文体-质量手册-实例

The terms and definitions referred in this Manual are as follows.

本手册有关章节中涉及下列术语和定义.

属类：应用文体-质量手册-实例

The items issued by the supplier after the delivery of medical device in order to take preventive or corrective measures and keep in compliance with national/regional law covering the following contents.

供方在医疗器械交付后,为了纠正或预防措施及符合国家和地区法规的要求而发布的事项,旨在以下方面给出补充信息和或宜采取的措施.

属类：应用文体-质量手册-实例

Risk refers to the combination of the degree and probability of damage.

风险指损害的发生概率与损害严重程度的结合。

属类：应用文体-质量手册-实例