We prepare this new version of Quality Manual in accordance with YY/T0287-2003 (ENISO13485: 2003)Medical Device Quality Management System-Requirements for Use in the regulatory framework, YY0033-2000 Sterilized Medical Device Production Management Specifications, and MDD-93/42/EEC Medical device directives, to meet customers’ demands on quality and improve the quality system.

为了满足顾客对产品质量的要求，改进质量体系，公司依据YY/T0287-2003(ENISO13485:2003)《医疗器械质量管理体系用于法规的要求》、YY0033-2000《无菌医疗器具生产管理规范》标准、MDD-93/42/EEC《医疗器械指令》组织编写了新版《质量手册》。

属类：应用文体-质量手册-实例

Mr. Xia Wenbo, the Assistant GM, is hereby appointed as our Management Representative in a bid to ensure continual stability of quality system and improve the performance of quality management, resulting in the realization of our commitment to meet customers’ quality demand.

为确保质量体系持续有效运行和保持，加强对质量管理体系的全面领导，以实现对顾客的质量承诺，特任命副总经理夏文波为公司管理者代表.

属类：应用文体-质量手册-实例

The terms and definitions in GB/T19000-2000 (ISO9001: 2000)Quality Management System Basic and Terms and YY/T0287-2003 (ISO13485: 2003)Medical Device Quality Management System-Requirements for Use in the regulatory framework and YY0033-2000 Standards are cited in this Manual.

本手册引用GB/T19000-2000(ISO9001:2000)《质量管理体系基础和术语》YY/T0287-2003(ISO13485:2003)《医疗器械质量管理体系用于法规的要求》和YY0033-2000标准的定义和术语。

属类：应用文体-质量手册-实例

This quality manual outlines the QMS of the Company established, implemented and maintained by the General Manager according to our own features and the requirements of YY/T0287-2003, YY0033-2000 and MDD-93/42/EEC, for assuring product quality to comply with customer requirements.

为保证产品及服务质量满足顾客要求，根据公司特点，依据YY/T0287-2003、YY0033-2000标准、MDD-93/42/EEC要求，由总经理领导建立、实施和保持质量管理体系.

属类：应用文体-质量手册-实例

Since the customers’ demand and expectation will vary to the development of market, the company will improve the QMS continually to satisfy customers’ changing demands meanwhile being strictly in compliance with national law, code and industrial specifications.

考虑到顾客的需求和期望会随着市场的发展而变化时，公司将在遵守国家法律，法规，行业规定，执行产品标准的同时，坚持质量体系的改进，以使顾客的需求和期望持续得到满足。

属类：应用文体-质量手册-实例

Every January, the Management Representative shall work out the general quality objective in accordance with the requirements of Quality Policy, Quality Objective Management Procedure and work in partnership with various departments to divide it into department-level objectives.

依据管理承诺、顾客要求的关注焦点及质量方针，每年元月管理者代表依据《质量方针、质量目标管理程序》的要求组织拟定公司总的质量目标，并和各有关部门配合将总目标分解到各个部门，形成完整的公司目标体系。

属类：应用文体-质量手册-实例

The input of management review shall include internal/external review results, customer feedback, process achievements, preventive and corrective measures, measures taken to meet the requirements of previous management review, any change which may influence the QMS, suggestions for improvement, new or modified laws and rules.

管理评审输入包括内/外审核结果,顾客反馈,过程业绩,预防和纠正措施情况,对前次管理评审采取的跟踪落实措施,可能影响质量管理体系的变更,改进的建议,新的或修订的法规要求。

属类：应用文体-质量手册-实例

To communicate and implement this Manual is the top responsibility of all the employees including the top management.

宣传、贯彻、执行本手册是公司各级领导及全体员工的首要职责。

属类：应用文体-质量手册-实例

From the date the new version SG/QA-A Quality Manual comes into force, the old version shall be annulled.

新版SG/QA-A《质量手册》实施后,原版SG/QA-A《质量手册》予以废止。

属类：应用文体-质量手册-实例

Be in compliance with national laws, codes and provide our customers with acceptable products.

严格遵守国家的法律、法规要求,提供给顾客的产品符合标准。

属类：应用文体-质量手册-实例

Response to customer’s complaints within 12 hrs and handle it within 48 hrs.

对顾客提出的质量投诉,答复不超过12小时,处理不超过48小时。

属类：应用文体-质量手册-实例

For the non-conformities found in the course of audit, the auditor makes a non-conformity report to the responsible department and they should put forward corrective actions plans and complete within the designated dates. The auditor is responsible for follows-up and verification.

审核中发现的不合格，由审核员开具不合格报告，责任部门认可后提出采取纠正措施计划，并按规定日期完成，审核员负责跟踪验证。

属类：应用文体-质量手册-实例

This Manual is aimed to ensure the implementation of our quality system meeting the requirements and objective of quality policy by defining the basic structure, functions and operating rules of quality management system.

本质量手册用以统一协调公司的质量管理和质量保证活动,规定了公司质量体系的基本结构、职能和运行规则,目的在于确保公司质量体系的运行符合质量方针和目标的要求.

属类：应用文体-质量手册-实例

Services available to customers lived in our city within 24 hrs, in our province within 48 hrs and outside our province within 72hrs.

对顾客提出的服务事项,市内不超过24小时,省内不超过48小时,省外72小时内予以解决。

属类：应用文体-质量手册-实例

To ensure the QMS are established, implemented and maintained.

确保质量管理体系得到建立、实施和保持.

属类：应用文体-质量手册-实例

To report to the General Manager on the performance of the QMS for review and improvement

向总经理报告质量管理体系的业绩,包括改进的需求

属类：应用文体-质量手册-实例

To convene management review meeting periodically to ensure the continual effectiveness of the QMS

定期召开管理评审会议以确保质量管理体系的持续有效

属类：应用文体-质量手册-实例

To promote the awareness of customer requirements in the Company.

在整个组织内促进顾客要求意识的形成

属类：应用文体-质量手册-实例

To liaise with external parties on QMS matters.

代表公司就质量体系问题与外部各方联络。

属类：应用文体-质量手册-实例

Quality Manual (hereinafter referred to as the Manual)is the standard and rule for the company’s quality management activities.

质量手册(以下简称手册)是公司有效地开展质量活动的标准和准则,是公司纲领性文件。

属类：应用文体-质量手册-实例