Home > About 3F > 3F Quality
QUALITY
Quality Assurance System
> General ISO13485 Quality Management System
> ISO9001 and ISO13485 Certificate
> CE Mark for Phoebe
> Show More...
> General ISO13485 Quality Management System
> ISO9001 and ISO13485 Certificate
> CE Mark for Phoebe
> Staffs entitled the ISO Quality System Engineer takes 10%
> New Staff outward course of ISO13485 and GB9706 (IE C60601-1)
> Every segment (development, manufacture, service…) goes in accordance with management system
> QA department responsible for overall control of the quality management if the company
> Complete and detailed system document in continuous improvement adopted as operation guidance
> Regular meeting held to analyze, evaluate and review the quality improvement
> Regular analysis and collection of quality information which can be helpful for the quality improvement plan in the department concerned
> Timely supervision and inspection for the quality improvement in every department of the company implicated to guarantee the implementation of the improvement activities
> Regular surveillance for the operation of Quality System adopted to guarantee the effectiveness of the system       > Hidde
Quality Guarantee in the Process of Developing
Engineers:
> Graduated from different high education schools
> Strong mechanical technical and software background
> Show More...
Engineers:
> Graduated from different high education schools
> Strong mechanical technical and software background
> Capability in electrophysiologic, ultrasound, adjuvant therapy and flexible unit designing
Principle Developer:
> More than 20 years’ experience in Research and Design
> Experienced in the development of more than 20 types of medical equipments
> Cooperated with many national and international partners in the developing of several products
> Tow products get iF Product Design Award       > Hidde
Quality Control in Developing
> Strict performance of Quality system
> Careful and prudent Risk Management
> Design review existed throughout the whole designing stages
> Show More...
> Strict performance of Quality system
> Careful and prudent Risk Management
> Design review existed throughout the whole designing stages
> Detailed and precise design review (In-house test, official test and Verification by state-level test centre)
> Abundant internal and external clinical trial before production       > Hidde
Production engineering and Improvement
> Production engineering department apart from research and design department
> Reliable engineering design which guarantee the reliability of the products
> Trial manufacture in small batches before production to avoid possible design defects
> Show More...
> Production engineering department apart from research and design department
> Reliable engineering design which guarantee the reliability of the products
> Trial manufacture in small batches before production to avoid possible design defects
> The possible craft quality problems from the production line and customer Service can be solved immediately
> Constant tests are used for a better technique to improve the quality of the products
      > Hidde
Suppliers of high quality
> Core components come from the notable companies both in and out of China
> Philips MCU, LG-Philips display screen, Atmel original device of electron, AMP socket connector, LEMO Interface…)
> High-caliber local suppliers guarantee the high quality and low costs of the production
> Show More...
> Core components come from the notable companies both in and out of China
> Philips MCU, LG-Philips display screen, Atmel original device of electron, AMP socket connector, LEMO Interface…)
> High-caliber local suppliers guarantee the high quality and low costs of the production
> Frequent supplier supervision and evaluation guarantee the high quality of suppliers
> Consistent supplier development attracts more and more suppliers into the AVL       > Hidde
Quality Control in manufacturing
> Strict and ongoing training in laws and regulations, quality consciousness, product information and manipulative skills
> Detailed working and inspection instructions and documentation
> Show More...
> Strict and ongoing training in laws and regulations, quality consciousness, product information and manipulative skills
> Detailed working and inspection instructions and documentation
> Clear and specific calibration requirements in each critical milestone
> Qualified safety testing and calibration equipments
> Strict IQC, IPQC and FQC procedures       > Hidde
Quality tracking and improvement system
> An engineering and quality control department is established to promptly deal with the problems in the production line and be responsible for the production engineering/improvement
> Any problems possibly influence the product quality will be immediately collected and solved by Engineering and Quality Control Department
> Show More...
> An engineering and quality control department is established to promptly deal with the problems in the production line and be responsible for the production engineering/improvement
> Any problems possibly influence the product quality will be immediately collected and solved by Engineering and Quality Control Department
> Timely collection and analysis of the quality information in the production line and grasp the key point to improve the product quality
> Consistent engineering ,sourcing and supplier improvement in accordance with analysis
> Lots of test jigs are developed to improve the quality control measure during the course of production
> Complete products tracking system which collects information of all equipments: serial number of equipments and components, assemble record, debugging record, test record and maintenance record
> Customer service in charge of the field installation, training, maintenance and the collection and processing of the feedback information
> Special training for important customers and distributors which help them to better learn the correct method of using and maintenance
> Immediate response to after-sale quality problems by means of directions, field maintenance, foldback maintenance and replacement
> Quality information is collected and concluded by the quality assurance department and used as the basis for improvement
> Information Collection
   -Immediate feedback to customers’ requirements for product improvement in customer Service and Sales department
   -Regular collection of the quality information in the production line
   -Timely collection of the purchasing information
> The collection and processing of the information
   -Routine or temporary quality meeting are held in the QA department to analyze and discuss the quality information collected
> The adoption and supervision for the protective steps
   -QA department takes responsibility of all sorts of quality improvements, and monitor momentarily to assure the effective implementation       > Hidde
Key links of the Quality control
> Design verification
   -Design verification run through the whole designing stages to avoid the subsequent problems
> Production engineering and improvement
> Show More...
> Design verification
   -Design verification run through the whole designing stages to avoid the subsequent problems
> Production engineering and improvement
   -Production engineering directly affects the reliability and maintainability of the products
> Supplier management
   -Suppliers for processing closely related to manufacturing sector
> Industrial control
   -In addition to regular training, the strict industrial control are adopted together with the quipment design to improve the quality control in manufacturing
> Message feedback and improvement
   -The quality control feedback collected in the system provides us basis to improve the qualitu and service       > Hidde
Copyright © 2008 Shanghai 3F Electronics Co.,Ltd All rights reserved