英文版最新ISO9001：2015&ISO13485：2016&FDAQSR820全套文件(手册+程序文件)1Word格式.docx

1、 Scope 22. Applicable Standards23. Business Profile 24. Authority & Responsibility25. Terms & Definitions 26. Policy & Objectives 37. Application 48. Quality Management System 49. Management Responsibility 610. Resource Management 811. Product Realization 812. Purchasing 1113. Production Control / P

2、roduct Identification & Traceability 1214. Control of Inspection, Measuring, and Test Equipment 1315. Measurement, Analysis, Improvement 14 ScopeThis manual describes the Quality Management System （QMS） established by and forDongguan DaMei Appliances Limited.The principles and policies on which this

3、 manual is based; along with operating procedures, work instruc-tions, and other supporting documents; govern all processes that affect quality throughout the organiza-tion.2. Applicable Standards2.1 The QMS is structured and intended to be in compliance with the following standards.ISO 13485:2016 M

4、edical Devices Quality Management Systems Requirements for Regulatory Purposes21 CFR Part 820 Quality System Regulation （Exclusions and Exceptions noted below.）2.2 Normative ReferencesISO 9000:2015 Quality Management Systems Fundamentals and Vocabulary2016 Medical devices Quality Management Systems

5、Guidance on the Application of ISO 13485:20163. Business Profile3.1 Mission StatementTo deliver zero defects to our internal and external suppliers and customers.3.2 DaMei, with one facility located at Block S, Yinyang Industrial City, Zhangmutou Town, Dongguan City, Guangdong Province, China.3.3 Th

6、e organizational structure is described by Dongguan DaMei Appliances Limited Organization Chart. Responsibility4.1 This manual is issued under the authority of the President.4.2 It is the responsibility of the Director of Quality, who is the designated Management Representative, to ensure that the p

7、rinciples of this manual, the Quality Policy, quality objectives, customer requirements, applicable regulatory requirements, and quality management system requirements are promoted, com-municated to and understood by all DaMei employees. Definitions5.1 Corrective ActionA process improvement methodol

8、ogy aimed at identifying and eliminating the causes of known non-conformities to prevent their recurrence. A problem solving process.5.2 Customer1. A business entity and the individuals representing it that specify and purchase products produced by DaMei.2. A business entity considering DaMei as a p

9、otential supplier.5.3 Customer ComplaintA communication from a customer expressing dissatisfaction with product or service or a concern based on observations or perceptions of DaMei; classified as Formal Complaint, Informal Complaint, or Customer Return.5.4 Customer FeedbackCustomer assessment of Da

10、Meis performance as it relates to meeting customer requirements and/or expectations.5.5 ProcessA set of interrelated resources and activities; i.e. people, materials, equipment, environment, methods; used to transform specific inputs into specific outputs.5.6 Product1. The end result of activities p

11、erformed and resources applied by DaMei; a process output.2. Purchased goods and services.5.7 Preventive ActionA process improvement methodology aimed at identifying and eliminating potential causes of noncon-formities before they occur.A risk management process.5.8 QualifiedHaving attained the know

12、ledge, skills, or other attributes necessary to perform a particular activity or task in accordance with specified requirements. Objectives6.1 Quality PolicyOur goal, at DaMei, is to provide products and services that comply with applicable requirements and exceed our customers expectations. This wi

13、ll be accomplished through employee involvement and ongoing education to ensure continuous improvement of our processes.This quality policy is communicated to all employees as part of their training, with the intent of provid-ing a clear, common understanding, directly applicable to their work. The

14、quality policy is reviewed at least once per year for continuing suitability and adequacy.6.2 Quality Objectives Only Defect-Free Product and Services shipped/provided to customers/suppliers Continuous Improvement in Delivery Performance through the Utilization of Capable Processes Maintenance/Conti

15、nuation of ISO 13485 Certification7. Application7.1 The QMS described in this manual is applicable in contractual situations entailing the manufacture of components/devices in accordance with customer specifications.7.2 ExclusionsParticular Requirements for Sterile Medical DevicesDaMei does not perform sterilization of any kind.Record maintenance of sterilization process parameters is not applicable to DaMei.8. Quality Management System8.1