实验室质量管理手册–中英文word编辑档可获取!-夜雨聆风

实验室质量管理手册–中英文word编辑档可获取!

质量文库：质量人的资料库

实验室质量管理手册

目录 Table of contents

0.1修改记录 REVISION RECORD 4

0.2发布令 ISSUING NOTICE 5

0.3公正性与质量承诺 IMPARTIAL AND QUALITY COMMITMENT 6

0.4质量方针与目标 QUALITY POLICY AND OBJECTS 7

0.5前言 PREFACE 8

1.适用范围 SCOPE 9

2.引用文件 NORMATIVE REFERENCES 10

3.术语和定义 TERMS AND DEFINITIONS 11

4.通用要求 GENERAL REQUIREMENTS 12

4.1公正性和独立性 IMPARTIALITY AND INDEPENDENCE 12

4.2保密性 CONFIDENTIALITY 14

5.结构要求 STRUCTURAL REQUIREMENTS 15

5.1行政管理要求 ADMINISTRATIVE REQUIREMENTS 15

5.2组织和管理 ORGANIZATION AND MANAGEMENT 15

6.0资源要求 RESOURCE REQUIREMENTS 17

6.1人员 PERSONNEL 17

6.2设施和设备 FACILITIES AND EQUIPMENT 19

6.3分包 SUBCONTRACTING 21

7过程要求 PROCESS REQUIREMENTS 22

7.1检验方法和程序 INSPECTION METHODS AND PROCEDURES 22

7.2检验项目和样品的处置 HANDLING INSPECTION ITEMS AND SAMPLES 24

7.3检验记录 INSPECTION RECORDS 24

7.4检验报告和检验证书 INSPECTION REPORTS AND INSPECTION CERTIFICATES 24

7.5投诉和申诉 COMPLAINTS AND APPEALS 25

7.6投诉和申诉过程 COMPLAINTS AND APPEALS PROCESS 25

8管理体系要求 MANAGEMENT SYSTEM REQUIREMENTS 27

8.1方式 OPTIONS 27

8.2管理体系文件 MANAGEMENT SYSTEM DOCUMENTATION 27

8.3管理系统文件控制 CONTROL OF MANAGEMENT SYSTEM DOCUMENTS 28

8.4记录控制 CONTROL OF RECORDS 29

8.5管理评审 MANAGEMENT REVIEWS 30

8.6内部审核 INTERNAL AUDITS 31

8.7纠正措施 CORRECTIVE ACTIONS 32

附件 1：营业执照 ANNEX 1: BUSINESS LICENSE 34

附件 2：各认可规则及程序文件对照表 ANNEX 2:THE COMPARISON TABLE FOR THE CAUSEES AND THE PROCEDURES 35

附件 3：各部门职能分配表 ANNEX 3:THE CROSS TABLE FOR THE CAUSES AND THE RESPONSIBILITY OF THE DEPT 37

附件 4：新旧文件编号对照表 ANNEX 4: COMPARISON TABLE FOR NEW AND OLD PROCEDURE 39

附件 5：任命书 ANNEX 6:APPOINTMENT LETTER 40

0.2发布令 Issuing Notice

本手册依据 CNAS-CI01 及相关应用说明、相关要求及其它相关认可机构和客户要求，结合我公司具体情况编制，是阐述公司质量方针，质量目标与质量体系的纲领性文件，是公司质量管理和技术改进的保证，是公司质量体系审核的依据，是公司进行各项质量和技术活动必须遵偱的准则。

本手册已经包含了检验机构能力的通用要求。

经审定，本手册符合公司管理体系实际情况，现予以正式发布，从即日起正式实施，全公司人员必须遵照执行。

The quality manual is made according to CNAS-CI01 and the relevant Accreditation criteria and other accreditation body and the customer, Combined with our company status, it is programmatic document of company quality policy, quality objectives and quality system, it is ensure company quality management and technology improvement , it is the basis of company quality system audit, it is the guidelines of company quality and technology activities must abide.

The manual is already contains general requirements for inspection body.

The manual conform to company’s management system situation .It is allowed to release officially, implement from now on, all the company staff must comply with it.

最高管理者：

Top Management

2024 年 06 月 12 日