ISO13485：2022质量手册英文版(修改公司名及程序名就可直接套用).docx

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1、ISO13485：2022质量手册英文版(修改公司名及程序名就可直接套用) Table of Contents 1. Purpose & Scope (2) 2. Applicable Standards (2) 3. Business Profile (2) 4. Authority & Responsibility (2) 5. Terms & Definitions (2) 6. Policy & Objectives (3) 7. Application (4) 8. Quality Management System (4) 9. Management Responsibility

2、(6) 10. Resource Management (8) 11. Product Realization (8) 12. Purchasing (11) 13. Production Control / Product Identification & Traceability (12) 14. Control of Inspection, Measuring, and Test Equipment (13) 15. Measurement, Analysis, Improvement (14) 1. Purpose & Scope This manual describes the Q

3、uality Management System (QMS) established by and for Dongguan XXX Appliances Limited. The principles and policies on which this manual is based; along with operating procedures, work instruc-tions, and other supporting documents; govern all processes that affect quality throughout the organiza-tion

4、. 2. Applicable Standards 2.1 The QMS is structured and intended to be in compliance with the following standards. ISO 13485:2022 Medical Devices Quality Management Systems Requirements for Regulatory Purposes 21 CFR Part 820 Quality System Regulation (Exclusions and Exceptions noted below.) 2.2 Nor

5、mative References ISO 9000:2022 Quality Management Systems Fundamentals and Vocabulary ISO 13485:2022 Medical devices Quality Management Systems Guidance on the Application of ISO 13485:2022 3. Business Profile 3.1 Mission Statement To deliver zero defects to our internal and external suppliers and

6、customers. 3.2 XXX, with one facility located at xxx, Dongguan City, Guangdong Province, China. 3.3 The organizational structure is described by Dongguan XXX Appliances Limited Organization Chart. 4. Authority & Responsibility 4.1 This manual is issued under the authority of the President. 4.2 It is

7、 the responsibility of the Director of Quality, who is the designated Management Representative, to ensure that the principles of this manual, the Quality Policy, quality objectives, customer requirements, applicable regulatory requirements, and quality management system requirements are promoted, c

8、om-municated to and understood by all XXX employees. 5. Terms & Definitions 5.1 Corrective Action A process improvement methodology aimed at identifying and eliminating the causes of known non-conformities to prevent their recurrence. A problem solving process. 5.2 Customer 1. A business entity and

9、the individuals representing it that specify and purchase products produced by XXX. 2. A business entity considering XXX as a potential supplier. 5.3 Customer Complaint A communication from a customer expressing dissatisfaction with product or service or a concern based on observations or perception

10、s of XXX; classified as Formal Complaint, Informal Complaint, or Customer Return. 5.4 Customer Feedback Customer assessment of XXXs performance as it relates to meeting customer requirements and/or expectations. 5.5 Process A set of interrelated resources and activities; i.e. people, materials, equi

11、pment, environment, methods; used to transform specific inputs into specific outputs. 5.6 Product 1. The end result of activities performed and resources applied by XXX; a process output. 2. Purchased goods and services. 5.7 Preventive Action A process improvement methodology aimed at identifying an

12、d eliminating potential causes of noncon-formities before they occur. A risk management process. 5.8 Qualified Having attained the knowledge, skills, or other attributes necessary to perform a particular activity or task in accordance with specified requirements. 6. Policy & Objectives 6.1 Quality P

13、olicy Our goal, at XXX, is to provide products and services that comply with applicable requirements and exceed our customers expectations. This will be accomplis hed through employee involvement and ongoing education to ensure continuous improvement of our processes. This quality policy is communic

14、ated to all employees as part of their training, with the intent of provid-ing a clear, common understanding, directly applicable to their work. The quality policy is reviewed at least once per year for continuing suitability and adequacy. 6.2 Quality Objectives ? Only Defect-Free Product and Servic

15、es shipped/provided to customers/suppliers ? Continuous Improvement in Delivery Performance through the Utilization of Capable Processes ? Maintenance/Continuation of ISO 13485 Certification 7. Application 7.1 The QMS described in this manual is applicable in contractual situations entailing the man

16、ufacture of components/devices in accordance with customer specifications. 7.2 Exclusions Particular Requirements for Sterile Medical Devices XXX does not perform sterilization of any kind. Record maintenance of sterilization process parameters is not applicable to XXX. 8. Quality Management System

17、8.1 General 8.1.1 XXX has developed, documented, implemented, and maintains its QMS in accordance with ISO 13485:2022, and 21 CFR Part 820. 8.1.2 XXX applies a risk-based approach to the control of appropriate processes needed for the quality management system utilizing the methods specified in ISO/

18、IEC 31010:2022, Risk management - Risk assessment techniques, which is used as guidance on selection and application of systematic techniques for risk assessment. 8.1.3 The QMS is based on a process approach to quality management and XXX applies continuous process improvement methodology, i.e. the P

19、lan-Do-Check-Act Cycle (Figure 1), to ensure its on-going effectiveness. 8.1.4 System processes, including their interrelationships and correlation to ISO 13485:2022 sub-clauses, are described in the appendices of this manual. 8.2 Document Control 8.2.1 The document system is tiered as shown in Figu

20、re 2. 8.2.2 All documents comprising the QMS; i.e. this Quality Manual, Procedures, Work Instructions, Forms; their current revision level and file type are listed and controlled. 8.2.3 QMS documents are controlled and revised as described in procedure Control of Docu-ments. 8.2.4 Records required b

21、y the QMS, ISO 13485:2022, and 21 CFR Part 820 are maintained in accordance with procedure Control of Records. 8.3 References Control of Documents Control of Records 9. Management Responsibility 9.1 General 9.1.1 XXX management is committed to the development and implementation of the QMS and fully

22、supports maintaining its effectiveness by: ? communicating, to all functions and levels within XXX, the importance of meeting customer, appli-cable regulatory, and statutory requirements. ? establishing an appropriate quality policy and me asurable objectives and ensuring these are com-municated and

23、 understood throughout the company. ? providing a framework for review of quality objectives and processes, including regularly scheduled Management Reviews to ensure continuing suitability, adequacy, and effectiveness of the QMS. ? ensuring the integrity of the QMS as changes are planned and implem

24、ented. ? allocating sufficient resources and providing education and/or training as required. 9.1.2 Management is ultimately responsible for determining and satisfying customer/product require-ments. 9.1.3 Roles, responsibilities, authorities, and their interrelationships are clearly defined, docume

25、nted, and communicated within XXX. Personnel who manage, perform, and/or verify work affecting quality have the authority and inde-pendence to perform these tasks effectively. 9.2 The Director of Quality serves as the Management Representative and, as such, is responsible and fully authorized to man

26、age the QMS and related matters on an ongoing basis. Roles and responsibili-ties include the following. ? Interprets applicable standards and continually verifies QMS compliance. ? Ensures that required processes are documented, implemented, and maintained. ? Advises the management team regarding operation and effectiveness of the QMS and opportuni-ties for improvement.