We place a strong emphasis on adopting quality control and assurance systems that meet the international and industry standards for medical devices, which is illustrated by the fact that we were the first Hong Kong-headquartered medical device group to obtain the ISO14971 certificate for the application of risk management to medical devices. We obtained the ISO 9001:2000 and ISO 9001:2010 standards in 2000 and 2010, respectively. We did not renew the ISO 9001 certification upon its expiry in 2015 as the relevant quality management system for the design and manufacture of medical devices is covered by the ISO 13485 standard, which we obtained in 2004.
Qualification and Recognitions
Vincent Medical complies with Global Standards for the medical products industry and currently holds the following certificates:
- Certification of Assessment - EC
- ISO 13485 & ISO 11135
- ISO 14971
- Medical Device Manufacturing License (醫療器械生產許可證)
- Medical Device Registration Certificate (醫療器械註冊證書)
Quality Assurance Processes
Our quality assurance measures cover all aspects of our production processes and operations, including design installation and maintenance of production facilities, procurement of raw materials and packaging materials, monitoring and quality checks of raw materials, semi-finished products and finished products and verification of documentation to comply with product registration certification standards and requirements. In every production process, dedicated quality inspectors are assigned to inspect each process according to pre-determined standards and inspection conditions and to record inspection results.
Production process validation procedure
Our quality assurance system implements a comprehensive procedure for validation of our production process, which includes planning, installation qualification, design qualification, operational qualification, performance qualification, process control and management and revalidation.
Raw materials quality control
We purchase raw materials only from approved suppliers, which our supplier audit team has assessed based on a set of criteria. Our quality control team inspects the quality of each batch of supplies based on their documentation, specifications and qualities on a sampling basis in accordance with the relevant industry or agreed standards. Only raw materials satisfying all of our specifications and requirements will be accepted and used for our production.
Production in-process quality control
Our quality control team consistently monitors our production processes to verify that our manufacturing processes continue to comply with our standards. We require our production staff to adhere to the standard operating and equipment operation procedures. Our quality control team regularly inspects our production processes on-site and conducts checking on certain semi-finished products at certain stages of production on a sampling basis as required by the approved procedures.
Finished product quality control
Our quality control team conducts inspection on each piece of our medical equipment products, and our in-house laboratory conducts inspection and testing on the functionality and durability of each of such product. We inspect and test disposable products on a sampling basis, in accordance with our quality control procedures. We conduct various testing, such as leakage test, air flow resistance test, breathing bag volume test, breathing circuit pull test and compliance test, moisture loss test, on a sampling basis on our finished products.
Before we deliver our final products to customers, our quality control team inspects the documentation relating to the quality of a product, including its batch records, production process records and other information that may impact product quality.
We dispose of finished products that do not meet our quality standards and only release and sell finished products that have passed all specifications and requirements.
Microbiological and analytical testing laboratory
We operate an in-house microbiological and analytical testing laboratory, which performs sample checking on our disposable products, in particular on the level of viruses and bacteria, in order to ensure strict adherence to our customer’s products requirements. It also performs testing on the cleanliness level of the Class 100,000 clean room environment of our production facilities on a weekly basis. The laboratory has capability of conducting product sterility testing, bioburden testing, environmental monitoring, bacterial endotoxin testing and biological indicator sterility testing.
Measurement and performance test laboratory
We also operate a measurement and performance test laboratory which conducts various physical and functionality testings, including dimension measurement, accelerated aging test, temperature and humidity environment test, ISO conical connector test; breathing circuit pull test, air flow resistance test, compliance test; and moisture loss test, air leakage test, flow resistance test for heat and moisture exchanger, on first article samples, components, semi-finished products or finished products. It also conduct testing on the functioning of each piece of our respiratory equipment with electronic components.