供应商质量体系及监督审查之程序中英文对照Word文档格式.docx

1、 DRAFTWilliam MagramoDRAFT May 19Initial ReleaseApproved DCN on File in Document ControlAPPROVED BYMotoaki WakuiAUTHORIZED BYSK LamCONFIDENTIALPROPERTY OF ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDThis document, and the information it contains, are the property of Zhongshan Sunming Optical Techn

2、ologies Limited and are protected by law. Both must be held in strict confidence at all times. No license expressed or implied, under any patent, copyright or other intellectual property right is granted or implied by the provision or possession of this document. No part of this document may be repr

3、oduced, transmitted, transcribed, stored in a retrieval system, translated into any language or computer language, in any form or by any means, whatsoever, without the prior written consent of Zhongshan Sunming Optical Technologies Limited.2014 ZHONGSHAN SUNMING OPTICAL TECHNOLOGIES LIMITEDALL RIGHT

4、S RESERVED1. PURPOSE 目的1.1 This specification describes the general requirement and procedure for quality systems and surveillance audit of SUNMING Supplier. 此规格书描述了SUNMING对供应商质量体系的一般要求及监督审查程序。1.2 SUNMING use a quality system assessment tool “Attachment 1” to ensure that suppliers supplying products

5、 or material piece parts meet all the requirements for basic quality systems as defined by the company. The requirements specified are aimed primarily at achieving customer satisfaction by preventing non conformity at all stages from design through to servicing. SUNMING使用质量体系评估工具（附件1）确保供应商提供的产品或材料部件

6、符合公司基本质 量体系的要求。这些要求所要达成的目标是从研发到售后服务预防不合格品的发生并将客户的满 意度放在第一位。2. SCOPE 范围2.1. Any supplier of all direct materials as described below where the requirement for the audit toISO 9001 are identified.ISO 9001要求审核直接材料供应商包括以下所描述的方面 Electro Mechanical 电子机械 Electrical Hardware电气硬件 Electrical Connection 电气连接 3.

7、 DEFINITIONS & ABBREVIATIONS 定义与缩写4.1 QSA- Quality System Audit 质量体系审核4.2 SQE- Supplier Quality Engineer 供应商质量工程师4.3 CLCA Close Loop Corrective Action 闭环更正措施4.6 SUNMING Zhongshan Sunming Optical Technologies Limited （China registered company）/ Sunming Technologies （HK） Limited （Hong Kong registered

8、company） 中山三鸣光学科技有限公司 （中国注册公司）/ 三鸣科技香港有限公司 （香港注册公司）4. ASSOCIATED DOCUMENTS 相关文件4.1 ISO 9001 Quality Management Systems Requirements ISO 9001质量管理体系要求5. GENERAL REQUIREMENTS 一般要求5.1 QA （SQE） and Purchasing （Buyer） should conduct Supplier Quality Audit. If necessary, additional personnel shall be inclu

9、ded in the audit Team to provide technical expertise （e.g. from R&D and Manufacturing）. QA部门（供应商质量工程师）及采购部门（采购员）应实施供应商质量审核。 必要的话，审核小组要包含其他人提供专业技术（例如：研发部或生产部人员的加入）。 5.2 Supplier Classification 供应商等级 Level 1 - Suppliers who are ISO 9001 certified. 1级 - 获ISO 9001认证的供应商 Level 2 - Suppliers who are not I

10、SO 9001 certified. 2级 - 未获得ISO 9001认证的供应商 5.2.1 Level 1 Suppliers 1级供应商 5.2.1.1 Level “1” suppliers are audited for minimum of once every year and skip for two years if there is no quality issue or complain. 1级供应商每年至少审核一次，若没有质量问题或投诉可以两年审核一次。 5.2.1.2 Supplier Quality Engineer （SQE） shall require supp

11、liers to send the latest copy of ISO certificate for file and reference. 供应商质量工程师应要求供应商发送最新的ISO证书副本以归档并参考。 5.2.2 Level “2”suppliers are audited for minimum of once every six months. 2级供应商至少6个月需审核一次。5.3 Audit Preparation and Questionnaire 审核准备及问卷5.3.1 Prior to the audit, a copy of the quality audit q

12、uestionnaire, “Attachment 1,” shall be send to the proposed auditee for completion in two weeks time. 审核前，将质量审核问卷（附件1）发送给被审核单位，被审核单位需在两周内完成问卷。5.3.2 Prior a week to the audit, the auditee shall return the completed questionnaire together with any additional information required i.e. Organizational ch

13、art, Quality certification, Company product Brochure, Quality System Certification, Audit records for the past six months both internal and external audit, & General Information Sheet. 审核前一周，被审核单位需将完成的问卷同要求的其他附加信息一起送还，附加信息包含： 组织结构图，质量证书，公司产品手册，质量体系证书，过去6个月里内部及外部的审核 记录，一般信息表。 5.3.3 The auditee shall

14、be notified on the proposed audit and date. 审核方需通知被审核方审核计划及日期。 5.3.4 The exact date shall be agreed between the auditee and auditor. 审核日期需经过双方确认一致。5.4 Audit Checklist Requirement 审核清单要求 The following documents and procedures need to be provided by the auditee at the beginning of the audit to expedit

15、e the audit process. 被审核方在审核初期需提供以下文件及制程使审核顺利进行： 5.4.1 Workmanship standards 工艺标准 5.4.1.1 Drawings if applicable 图纸，如果适用的话 5.4.1.2 Test Specifications 测试规格书 5.4.1.3 Product specifications 产品规格书 5.4.1.4 Manufacturing/Quality Plans 制造 / 品质计划 5.4.2 Quality Manual 质量手册 5.4.3 Quality Manual level 2 procedures 质量手册2及程序文件 5.4.4 Quality Performance Measures 质量绩效评估 5.4.5 Process Flow Diagrams 制程流程图 5.4.6 Organization Chart（s） 组织机构图 5.4.7 Job Descriptions 工作描述 5