ISO 13485 compliant manufacturer and supplier丨Genteel Homecare Products

Quality System Certification

We hold the certification of its quality management system compliant with ISO 13485:2016. It is an internationally recognized quality management system standard that served as an aid in supporting compliance with the Medical Device Directive. We place considerable emphasis on following standard procedures with sufficient quality records and integrating well-developed quality management systems into our daily operation. It secures consistency in our products and services and also boosts the confidence of our partners to grow business with higher customer satisfaction ratings.

Incoming Quality Control

We have well-trained IQC workers to conduct incoming quality control upon receiving. With the IQC management system and in-house testing equipment to verify whether the size, appearance, hardness, thickness of raw materials, and components meet our requirements of the product’s intended application before processing.

In-progress Quality Control

In-progress quality control is essential to monitor the production process. Our IPQC will approve the first article before processing, conduct spot check every two hours, and inspect semi-finished products per AQL before hand-over to the warehouse with the application of processing regulation and the in-progress quality system.

Final Quality Control

First Article

In-line Inspection

Before assembly, the first article will be made by a skilled worker, as per assembly instruction and packaging instructions, and approved by the FQC worker before mass production.

Before packaging, FQC inspects every piece in the line to check the appearance, function, dimension, etc. per inspection standards for finished products and to keep records on time. If major defects happen or the same defective issue happens continuously, the cell leader will report it to the supervisor for an immediate solution.

Outgoing Quality Control

Appearance

Dimension

Function

Packaging

Appearance

The first impression is everything. We understand how the appearance of a product could affect how likable the product is to customers. With a better brand image for you, products are carefully inspected by our professional QC workers to make sure appearance is consistent with your demands.

Dimension

The dimension requirements vary across different items. At Genteel, the dimensions required closer attention during the final inspection are well defined on inspection standards for awareness and are carefully measured by our experienced inspectors with a detailed record on the OQC report for traceability.

Function

We know the concerns of our customers for function. Functional inspections are crucial here at Genteel, and our inspectors will inspect according to the expected application of the product specified in the finished product inspection standard.

Packaging

We are aware that packaging is a critical factor in product satisfaction. At Genteel, packaging inspections are conducted seriously to make sure the product package is according to the packaging working instructions, with correct printing in the appointed position and all the protective materials added in the right place to ensure proper protection of products during transportation.

Advanced Testing Lab

Product safety is crucial at Genteel. We utilize all kinds of inspection equipment and train professional testers to ensure that our products strictly tested in-house.

In the product design and development stage, we will verify that the product meets the legal standards of the target market.

In the quality control stage, we will arrange the chemical analysis test, physical property test, and mechanical property test of materials and components.

In the mass production phase, we will select the product according to the annual test plan to arrange the reliability test of the finished product and verify that the product continues to meet the design standards and regulatory requirements.

Spectrum Analyzer

To verify the quality of raw materials, for every batch, we use spectrum analyzer to test the chemical composition of the metal. Major metal including aluminum, stainless steel and copper are tested. This makes sure of the reliability of the raw materials, guaranteeing the durability of finished products.

Automated Digital Image Measuring Instrument

We utilize an automated digital image measuring instrument with the integration of professional software, aimed at measuring the size, angle, and arc of a complicated component accurately.

Fatigue Testing Machine

We will conduct fatigue testing on various kinds of products per the applicable ISO standard. The fatigue testing machine is to simulate the situations that consumers use the product, ensuring that the fatigue life of this product is long enough after a certain number of cycles, with no cracks or fractures on the tested sample.

Wheel Fatigue Testing Machine

Wheel fatigue testing is to simulate wheel rolling in general use situations and assess the fatigue life of the tested wheel sample during the incoming quality inspection and verification of new wheels developed by engineers.

Universal Testing Machine

The universal testing machine can evaluate materials properties such as tensile strength, strain hardening, plastic deformation, and so on. The maximum force and maximum deformation could be measured by this machine so that we can know the strength and toughness of different materials for verification. For those parts that we are unable to confirm the quality through the general inspection methods, we will use this test equipment, regardless of whether it is in the manufacturing stage, process improvement stage, or developing phrase.

Programmable Temperature and Humidity Test Chamber

Programmable Temperature and Humidity Test Chamber simulates several temperatures and humidity conditions to test the aging resistance, thus decide the performance of some plastic component, the stickiness of product label, etc.

Salt Spray Testing

Coated metal will be exposed in a high-saline environment over extended periods to determine the suitability to resist corrosion.

Digital Hardness Tester

A digital hardness tester ensures a precise hardness measurement to assess the strength of materials.

Energy Dispersive X Fluorescence Analyzer

We understand the purpose of RoHS testing is to reduce the environmental effect and health impact of electronics. We utilize a user-friendly energy dispersive X fluorescence analyzer with stable performance and reliable operation to conduct RoHS analysis in-house when needed and help to verify compliance to the relevant EU RoHS directive for electronics.

Ink Colorfastness Tester

We use ink colorfastness tester to test the adhesion, wear, and abrasion resistance of the printed ink layer on the printing materials. By doing so, we come to know the quality of printing materials during incoming quality inspection.

Bursting Strength Tester

We use the Bursting Strength tester to measure the bursting strength of corrugated board subjected to increasing hydrostatic pressure. Only the qualified corrugated board verified by testing can be accepted, which ensures enough protection for your product.

Slope for Stability Test

To meet the requirements and methods of testing the static stability per ISO standard, we utilize a slope whose angle could be adjusted freely from 0°to 30° by the lever. This slope is driven by the motor to suit various loading conditions.

Information System Management

Genteel attaches great importance to and vigorously promote the information construction, now, our BI system through the integration of ERP, PLM, BPM, HR, CRM, QC, and other systems, generating many analysis report forms. Our managers can make full use of information management and control methods as a supporting role in the production, finance, R & D design, Customer Service, human resources, storage and logistics, quality assurance, and so on.

PLM

Our PLM system covers from conceptual design, detailed design, and process flow to manufacturing, focusing on our application requirements for collaboration between departments and sharing of enterprise product data. It realizes the unified management of design data, process data, and manufacturing data, supporting cross-department data processing and business collaboration. At present, our 2D, 3D drawings, work instruction, and so on, has been fully integrated into this collaborative management platform.

Barcode System

The WMS(Warehouse management system) in Genteel, based on the wireless network, Bar Code, automatic identification, and other technologies, realizes intelligent and efficient management of the whole process of the warehouse. It ensures the smooth flow of information in all operations of the warehouse and helps to grasp the inventory data in real-time. In the aspect of production process management, we apply information technologies in production management. Through the collection of real-time data and monitoring of the production flow process, we could fast trace and improve the quality problem, which ensures that semi-finished and finished products controlled at all manufacturing stages.

CRM

The CRM system helps us to understand the detailed information of the customer, promote communication with the customer, and coordinate the customer service resources. It helps to provide customers with the most timely and high-quality service and to establish a long-term and stable mutual benefit with our customers to increase a deeper understanding of the market and effectively grasp the development trend of the product.

BPM

The BPM process platform integrates processes scattered across systems by modeling, automating, managing, monitoring, and optimizing the entire life-cycle of internal and external business processes. It helps to achieve flexible, easy-to-use, interchanged information-based overall framework and environment, improving cross-department implementation and facilitating the realization of digital transformation.

QC System

Through the collection of inspection process data, we could generate real-time production of complete quality inspection records in the QC system. After the data analysis, a series of reports are formed to promote the management and control of the quality process, and then improve the quality of products. It facilitates the digitization, smart technologies, and platform of QC work. At the same time, separate documents could be input manually, forming a more efficient quality paperless system.

ERP

The ERP system has a complete solution and flexible functions to enhance the information flow speed and management efficiency of business processes such as order, inventory, procurement, production. It fully integrates the logistics and information flow in the factory, helping us to shorten the manufacturing cycle, improve the capacity utilization, the warehouse inventory turnover efficiency, and quickly establish an efficient production model. It helps us to record the production of each process in the workshop and can trace the production progress and in-process records.

BI business intelligence helps us to establish a customer-centered business philosophy, organizational model, business rules, and evaluation system, forming an overall scientific management and control system. It goes deep into every process of enterprise management implementation. It comprehensively and carefully covers the accurate data of ERP, PLM, HR, QC, and other systems. It helps all departments to work together, focusing on the control of the production process system and quality assurance system. It facilitates all departments to work together, focusing on the process control of the production process system and quality assurance system. Therefore, it helps us to control and manage our workers, property, materials supply, and marketing in integration, which improves the level of management in all areas.

MES

Being a manufacturing company, Genteel has introduced MES into our informatization system, to record, reflect, and analyze every step in the production process. Drawings of each material being processed, and the QC check points are all shown on the MES system, right at the operators’ finger tips, incorporated with each production task. MES records and shows the real-time progress of each process on the Kanban, supervisors and managers can adjust the production plan with flexibility.

Searching For A Reliable Manufacturer ?

Talk To Us