Quality Integrity Report


Quality Integrity Report

Zhejiang Medest Medical Device Technology Co., Ltd.

2023 Year 08 Month

 

Solemn Declaration

 

 

The Quality Integrity Report issued by our company is prepared in accordance with relevant national laws, regulations, rules on quality, as well as industry-specific quality standards and guidelines. The report accurately reflects the company’s current status regarding quality integrity and quality management practices. Our company assumes full responsibility for the objectivity of the report’s content, as well as for the authenticity and scientific validity of its related arguments and conclusions.

 

 

 

 

 

Zhejiang Medest Medical Device Technology Co., Ltd.

2023 Year 08 Month 18 Day

 

 

 

Organizational scope: Zhejiang Medest Medical Device Technology Co., Ltd.

Report time: 2022 Year 1 Month From the 1st to 2022 12 Month 31 Day

Release Cycle One year

How to Obtain the Report Through the company Official Website www.mateside.cn Download

 

Company Profile

Zhejiang Maidesite Medical Device Technology Co., Ltd. was established On October 26, 2022, the company was registered at Room 1601, Building 1, Xixi Tang Business Center, Cangqian Subdistrict, Yuhang District, Hangzhou City, Zhejiang Province, with Liu Zhikuo serving as its legal representative. The business scope includes licensed activities such as: operating Class III medical devices; manufacturing Class II medical devices; and producing Class III medical devices (for projects that require approval by law, operations can only commence after obtaining approval from relevant authorities—details of specific business activities are subject to approval outcomes). General business items include: selling Class II medical devices; retailing Class I medical devices; manufacturing Class I medical devices; distributing labor protection equipment; producing labor protection supplies; manufacturing protective gear for medical personnel (Class I medical devices); fabricating hardware products; conducting R&D on hardware products; selling hardware products; marketing plastic products; manufacturing plastic items; developing new material technologies; researching and developing metal products; producing experimental analysis instruments; advancing mechanical equipment R&D; providing rehabilitation assistive device fitting services; offering technical services, technology development, technical consulting, technology exchange, technology transfer, and technology promotion; facilitating technology import and export; handling import and export of goods; manufacturing furniture; producing furniture components; selling furniture; marketing smart home consumer devices; manufacturing smart home consumer equipment; producing household goods; and retailing household items (except for projects requiring statutory approval, the company operates independently under its business license in compliance with the law). Zhejiang Medest Medical Device Technology Co., Ltd. has made external investments in six companies and maintains one branch office.

Medstead Possessing independent intellectual property rights, To have 15 authorized and valid patents, including 2 invention patents, 9 utility model patents, and 4 design patents.

The company's main business is Products include: Electric nursing beds, electric height-adjustable desks, smart hospital beds Etc.

 

 

 

 

 

 

 

 

Eye    Record

 

 

Chapter One   Quality Philosophy

1.1 Mission

1.2 Vision

1.3 Values

1.4 Quality, Environmental, and Occupational Health & Safety Policy

Chapter Two   Quality Internal Management

2.1 Quality Management Organization

2.2 Quality Management System 3

Chapter Three   Quality Integrity

3.1 Quality Integrity Management

3.2 Quality Culture Development

Chapter Four   Quality Foundation

4.1 Product Standards and Patents

4.2 Measurement Level 8

4.3 Certification and Accreditation Status 8

4.4 Special Equipment Safety Management 8

Chapter Five   Product Quality Liability 10

Chapter Six   Quality Risk Management

6.1 Quality Complaints

6.2 Quality Risk Monitoring

6.3 Emergency Management

 

 

 

Chapter One   Quality Philosophy

 

1.1 Mission

Only develop products that serve user needs.

1.2 Vision

Dedicated to becoming a globally leading rehabilitation medical device company

1.3 Values

Achieve customers, work diligently and bravely, practice self-criticism, pursue win-win collaboration, and foster sincere teamwork based on integrity and trust.

 

1.4 Quality, Environmental, and Occupational Health & Safety Management Policy

People-oriented   Strive for excellence and continuous improvement   Pursuing excellence

Chapter Two   Quality Internal Management

2.1 Quality Management Organization

2.1.1  Manager Representative

Appointed by the company's top management and authorized to lead and oversee the quality management system. Responsible for driving the effective implementation, evaluation, and continuous improvement of the company's quality policies, objectives, and strategies. Specific responsibilities include:

-- According to ISO 9001:2020 15 Quality Management System   Requirements: Establish and improve the company's quality management system to enhance the level of quality management.

-- Based on the company's strategic development needs, the organization will revise, update, and refine the "Management Manual" and related documents.

-- Promote and implement the company's quality policy, and oversee and evaluate the operation of each unit's quality management system.

-- Supervise the implementation of the marketing department's quality improvement plan and enhance quality awareness, thereby improving the effectiveness of the quality management system.

-- Represent the company in external liaison and communication regarding matters related to quality management;

-- Report the performance of the quality management system to the company, including requirements for improvement.

2.1.2  Department of Continuous Improvement

-- Implement and enforce the company's quality standards. /Environment/Occupational Health and Safety Policy & Objectives: Carry out tasks in accordance with the responsibilities and authorities outlined in the Quality/Environment/Occupational Health and Safety Management System documents, ensuring the effective operation of the quality/environmental/occupational health and safety management system. Under the direct leadership of the company manager, diligently perform the functions related to quality management and quality testing. And it possesses independence in quality inspection work, ensuring the scientific rigor and impartiality of inspection results;

-- Responsible for establishing, implementing, and continuously improving the quality management system, and regularly preparing reports to be submitted to the Management Representative.

-- Quality of writing or revision /Environmental, Occupational Health and Safety Manual: Responsible for drafting or revising relevant content in procedural documents;

-- Coordinate closely with the internal audit team to ensure thorough audit activities, and implement corrective measures for any nonconformities identified. /Implementation and evaluation of preventive measures;

-- Responsible for supplier investigation and evaluation tasks; Responsible for quality inspection of raw materials and finished products, as well as process control during production; making judgments on product compliance, developing inspection standards, and organizing and implementing inspections.

-- Responsible for managing non-conforming products and approving the final disposition results of such products;

-- Responsible for the proper use, daily maintenance, and upkeep of the department's inspection and measurement equipment;

-- Responsible for participating in supplier evaluation activities; and involved in reviewing production schedule orders with special requirements.

-- Responsible for controlling product corrective and preventive actions, and ensuring effective implementation and monitoring of these measures.

-- Responsible for acquiring and identifying legal, regulatory, and other requirements related to product quality;

-- Responsible for identifying, updating, and evaluating environmental factors and hazard sources related to departmental responsibilities, as well as Daily control;

-- Responsible for customer satisfaction analysis and ensuring effective customer feedback management.

-- Assist in controlling product identification and traceability, and ensure their implementation.

-- Responsible for properly archiving and preserving the department's documentation records;

2.2 Quality Management System

2.2.1 Medstead Viewing quality as the foundation for development and the source of competitiveness, we consistently uphold the construction of a quality management system, dedicate ourselves to R&D projects that meet market demands, and actively embrace advanced management practices. The company has passed ISO9001 Quality Management System Certification  2022 This year, we adopted the Excellence Performance Management Model, continuously enhancing our quality management practices and boosting customer satisfaction by integrating various advanced management approaches.

The company's quality objective is:

a) Customer satisfaction rate reaches 96% The above;

b) Contract Performance Rate 98% The above;

c) Customer Complaint Handling Rate 100%

d) Production completed on time Success rate 96% That's all.

2.2.2 Company leaders clearly recognize that today’s market competition ultimately comes down to the battle for talent. As a result, the company continues to ramp up its efforts in providing employees with comprehensive education on product quality and robust training to enhance their professional skills. We’ve adopted a variety of approaches—inviting experts in and encouraging employees to step out—to continuously refine our employee education and training system. At the same time, we firmly combine training with rigorous assessment, carefully and thoughtfully aligning training content with both the company’s growth objectives and the individual needs of our staff. This multi-faceted, multi-level, and diversified approach ensures that employees gain valuable knowledge not only in internal management and business expertise but also in broader areas like overall competency and personal development. Through this well-rounded training framework, we’ve not only boosted employees’ professional capabilities but also significantly strengthened their sense of ownership and deepened their understanding of the company’s quality culture.

Chapter Three   Quality Integrity

3.1 Quality Integrity Management

3.1.1 Improve the quality system and strengthen quality management.

Since its establishment, the company has consistently focused on customers, continuously enhancing its quality management practices and refining its quality management system. By integrating national standards and Zhejiang Manufacturing Standards, we have optimized both production and operational processes, successfully establishing a robust and comprehensive quality management network. Moreover, multiple systems—such as the quality management system, environmental management system, and occupational health and safety management system—are operating efficiently within the organization. Complementing these efforts, we’ve also adopted an outstanding performance management model, all of which have significantly contributed to improving both workplace efficiency and product quality.

3.1.2 Strict node control, emphasizing process management

The company follows T/ZZB 2234 2021 "Electric Standing Desks" and T/ZZB 2931 2022 "Age-Friendly Electric Nursing Bed" The standard requires establishing critical quality checkpoints to ensure full coverage of all inspection items, with rigorous layered controls throughout the production process. A series of effective measures are implemented, including defined roles and responsibilities, process inspections, quality assessments, accountability mechanisms, quality traceability, and data-driven statistical analysis. This approach enables focused control over key processes while promoting standardized operations in routine procedures. By maintaining comprehensive oversight of the entire production workflow and effectively monitoring critical milestones, the initiative has significantly enhanced work quality and ensured product excellence.

3.1.3 Establish a supervision mechanism and implement accountability management.

The company has established a quality management evaluation and assessment system, conducting regular inspections and supervision of the Production Department. It encourages responsible departments and management personnel to respond swiftly and proactively address issues related to system operations, monitoring, and customer complaints, ensuring thorough and effective implementation of corrective measures—ultimately preventing the recurring issue of failing to correct or improve after quality or customer complaint problems arise.

3.1.4 Encourage full-team participation to achieve quality improvement.

The company places great emphasis on building a quality culture, encouraging all employees to actively participate in quality management, and continuously deepening initiatives such as rationalization proposals and daily quality improvements. Technological innovation These measures enable employees across the board to fully engage in every stage of quality improvement, enhancing product quality and sharing the fruits of these enhancements.

3.1.5 Upgrade information delivery and strengthen metric monitoring.

Under the premise of the company's quality policy requirements, the company plans its quality objectives for the following year annually, then cascades the overall goals down to each functional department. Each department further breaks down, tracks, analyzes, and improves its assigned controlled tasks, ensuring the achievement of the company’s overarching objectives. To enhance the accuracy and timeliness of quality information dissemination, the company has upgraded its quality information system.

3.2 Quality Culture Development

3.2.1 Integrity Education

The company implements quality integrity education through human resource control procedures and training management regulations. Establish a training plan, validate the training effectiveness through evaluation, and promote and publicize the spirit of quality integrity across the entire company. This includes all aspects such as corporate product R&D, production, procurement, sales, and service. Quality control in the product domain, building a corporate culture of integrity, public relations and event organization, environmental Conduct systematic training in areas such as workplace safety and occupational health.

3.2.2 Integrity and Self-Discipline

The company has successively obtained National High-Tech Enterprise, the Industry Finals of the 5th China Innovation and Entrepreneurship Competition, and First Prize in the E-Commerce Competition for Industrial Cluster Zones in Hebei Province 2022 Zhejiang Province's Well-Known Brands in Cross-Border E-commerce Exports Wait While brand awareness continues to rise, the company has always regarded building corporate quality and integrity as a vital component. By fostering advanced corporate values and adopting sound business principles, we operate in full compliance with the law and voluntarily submit ourselves to the supervision and management of relevant authorities.

3.2.3 Corporate Culture

A truly vibrant enterprise thrives because it is backed by a solid foundation of quality—after all, a company’s quality image is meticulously crafted by every single employee. Quality is the result of an accumulation throughout the entire production process; only by implementing rigorous checks at every stage and meticulous control at every point can we ensure that the final products not only meet but exceed expectations, earning the trust and confidence of consumers. To genuinely foster a positive quality culture, company leaders have actively encouraged open communication with employees, engaging them proactively and subtly to influence their thoughts. This approach ultimately shapes workers' understanding of the company's quality objectives, quality values, and quality behavioral standards. Sense of belonging , Establish The philosophy of "Quality First, Integrity-Based" In the atmosphere fostered by the quality culture, employees diligently work toward achieving the company's quality improvement goals, while simultaneously enhancing their own skills and significantly contributing to the development of the quality culture itself.

The company has built a highly qualified workforce—characterized by integrity, professional excellence, and unwavering dedication—by enhancing the ethical standards of honesty and trustworthiness among its employees. Always operating under the principle of compliance with laws and regulations, while placing consumer needs at the core of its strategy, the company leverages superior service as its primary means to conduct business and production activities. As a result, honesty and trustworthiness have become deeply embedded in every aspect of the company’s operations.

Chapter Four   Quality Foundation

4.1 Product standards, patents, innovation projects

Company Department of Continuous Improvement Monitor the technology innovation process, organize evaluations of innovative technologies, identify breakthroughs, and continuously drive technological advancement through ongoing innovation. The company has acquired 15 authorized valid patents, including 2 invention patents, 9 utility model patents, and 4 design patents.

4.2 Measurement Level

The company has established an effective metrology assurance system in accordance with national laws and regulations, led by Department of Continuous Improvement The company is responsible for managing its metrological instruments to ensure their accuracy and reliability. All existing measuring tools are sourced from well-known domestic and international brands, and we actively collaborate with [omitted entity] during verification and calibration processes. Hangzhou City The National Institute of Metrology and other statutory metrology institutions collaborate closely. By implementing an effective metrology system, they generate accurate and reliable measurement data to control and guide production, yielding significant economic and social benefits.

4.3 Certification and Accreditation Status

The company strictly adheres to ISO9001 quality management system requirements govern quality control, production process management, and outgoing product quality assurance. Meanwhile, product development is carried out using project management approaches, enhancing development efficiency and ensuring product quality. Currently, the company primarily adheres to the ISO9001 quality management system, the ISO14001 environmental management system, and I SO45001 Occupational health and safety management systems, among others.

4.4 Special Equipment Safety Management

Our company has established and continuously improved safety production management systems and safe operating procedures in accordance with relevant national laws, regulations, rules, and standards—and these are prominently displayed on the walls. We have also strengthened education and awareness programs for employees, rigorously enforced the implementation of these systems, ensuring their effective execution and successfully preventing any potential hazards. The "Three Violations" phenomenon has occurred.

To effectively prevent the occurrence of serious and especially large-scale accidents, the company has strengthened safety management for special equipment and specially trained personnel, refined its safety management systems for both, and implemented regular maintenance and inspections of all specialized equipment. Any identified issues are promptly addressed to ensure that the equipment remains in optimal working condition.

The company's specialized personnel, after undergoing training and passing the examination administered by their superior authorities, are certified to take up their posts, ensuring safe operations through standardized procedures.

 

Chapter Five   Product Quality Liability

Our company hereby solemnly commits to the following:

 

1 Our company strictly adheres to the "Product Quality Law of the People's Republic of China," the "Product Metrology Law of the People's Republic of China," and other relevant laws and regulations, conducting business with integrity and in full compliance with the law.

2. From the date of self-shipment, Product Under compliant storage and transportation conditions, the manufacturer shall provide the following services during the warranty period.

According to the instructions for use and maintenance, under proper transportation, storage, and usage by the user, from the date of purchase by the user Within 5 years, if damage occurs or the product fails to function properly due to manufacturing defects, the manufacturer shall repair or replace it free of charge for the user.

If users have any requests, Respond within 12 hours, and propose a solution to the issue within 48 hours.

For products requiring on-site installation, we will promptly provide the service at the agreed-upon time starting from the date the customer receives the goods. This includes free installation and commissioning guidance, as well as daily maintenance instructions.

3 "During product research and development as well as the manufacturing process, we will never plagiarize others' technologies, patents, processes, or other intellectual property rights, nor will we ever use raw materials that incorporate stolen technology."

4 1. The surrounding environment and production site of this enterprise comply with national regulatory requirements.

5 Our company strictly adheres to the inspection system for raw and auxiliary materials; all raw materials, auxiliary materials, and packaging materials used comply with relevant national standards, industry standards, and associated regulations.

6 · No counterfeit or substandard raw materials are allowed into the factory, and no raw materials that fail inspection shall be used in production.

7 We guarantee that we will not produce or process counterfeit or substandard products, and we commit to conducting batch-by-batch inspections on all products before they leave the factory. Products that have not been inspected will never be released for shipment.

8 Products that fail inspection will never leave the factory, and we will never pass off nonconforming items as conforming products.

9 The instruments and equipment used are strictly calibrated in accordance with national legal requirements, and any equipment that fails calibration will never be employed for product testing.

10 • Ensure that every batch of products can be traced back to details such as the production date, shift, raw materials used, manufacturing process, and inspection personnel.

Chapter Six   Quality Risk Management

6.1 Quality Complaints

To standardize the customer complaint handling process, the company has formulated the “ Customer Complaint Handling Management Regulations 》,regarding the company's product quality management, promptly addressing and responding to customer feedback on quality issues, Marketing Department Based on customer quality feedback, promptly relay the information to production. Department And Department of Continuous Improvement , by Department of Continuous Improvement Responsible for handling customer feedback issues.

Customer Complaint Handling Flowchart

Record customer complaint details → Determine whether the customer complaint is valid → Identify the complaint handling department → Analyze the reasons And Propose handling opinions and solutions → Submit for approval by the supervisor → Implement the treatment plan → Summary and Evaluation

Marketing Department Responsible for receiving and forwarding complaints, ensuring that the resolution results are communicated and explained to the customers who filed the complaints—including comforting customers when they’re emotionally upset during the process.

Department of Continuous Improvement Responsible for Classification, transfer, and submission for approval of complaint handling, Organization Complaint Investigation of the root cause and supervision of the implementation of corrective and preventive measures.

Other departments analyze and investigate the reasons behind the complaints.

According to the customer complaint handling guidelines, prepare the "Compilation of Materials for Handling Product Quality Complaints from Customers." "Overall," we collect, consolidate, and analyze complaint information, promptly address issues and provide feedback, leveraging these insights to drive improvements within the company and with our partners, while also overseeing and evaluating the implementation of corrective actions.

Information collection and integrated management. We gather complaint information through customer follow-ups, website postings, and customer feedback. Once complaints are received, we systematically record, analyze, and organize them before forwarding them to the relevant departments for resolution according to established procedures. When analyzing complaint data, we utilize advanced statistical tools; for issues related to technical challenges or personnel quality, we employ methods like brainstorming sessions.

  Information analysis, sharing, and improved management. For complaints that are difficult to resolve, by Department of Continuous Improvement Include it in the list A dedicated ledger is used for analysis and organization, then shared accordingly. When similar complaints arise, they are handled based on the knowledge stored in the database, thereby enhancing the efficiency of complaint resolution.

6.2 Quality Risk Monitoring

6.2.1 Quality Control Points

The company focuses on controlling risks associated with critical quality characteristics, key areas, and vulnerable points by implementing appropriate management measures and methodologies, and has developed corresponding operational guidelines for critical positions. Through meticulous planning and management of personnel capabilities, equipment, materials, work instructions, environmental conditions, and performance evaluations at quality control points, the company ensures that risks related to critical quality features, key areas, and weak links remain effectively under control.

6.2.2 Quality Supervision Audit

Company Setup Department of Continuous Improvement By supervising various production sites, monitoring and inspecting the production process and adherence to process discipline, as well as following up on the corrective actions taken for issues identified during quality inspections, we ensure that these improvements are implemented promptly and effectively.

6.3 Emergency Management

To enhance our company's emergency response capabilities for sudden accidents and hazardous situations, ensuring smooth command and dispatch in the event of major or catastrophic incidents, as well as timely deployment of personnel, equipment, and resources, we aim to effectively control accidents promptly, safeguarding the lives of our employees, protecting the environment, and ensuring the security of national assets. By minimizing accident-related losses, we have formulated a Production Safety Emergency Response Plan based on relevant regulations such as the National "Work Safety Law," the "Emergency Response Law for Public Emergencies," and the "Administrative Measures for Emergency Plans for Production Safety Accidents," tailored specifically to our company's actual conditions. The Production Safety Emergency Response Plan is structured into two levels: the Comprehensive Emergency Plan and the Specialized Emergency Plan. The Comprehensive Emergency Plan serves as the overarching framework—outlining the company’s organizational management, command mechanisms, and coordinated procedures for mobilizing emergency resources and executing emergency actions. Meanwhile, the Specialized Emergency Plan, which is an integral part of the Comprehensive Plan, addresses specific types of emergencies or scenarios that may arise. Action plans and contingency measures tailored for various emergency scenarios. To ensure accurate and timely responses during emergencies, the company regularly organizes employees to conduct emergency drills, while identifying and addressing any issues that arise during these exercises. This proactive approach guarantees that, when an unexpected event occurs, the company can swiftly activate its emergency plan, effectively mitigating risks and minimizing potential harm.