ISO 13485:2003 is an international standard that defines quality management system requirements for manufacturers of medical devices. The primary objective is to facilitate harmonization of quality management system requirements amongst regulatory body within the medical device sector.
ISO 13485:2003 promotes harmonization of regulatory requirements for manufacturers of medical devices on an international scale. A number of countries have incorporated ISO 13485:2003 into their regulatory system. Compliance with ISO 13485:2003 can be used in support of regulatory compliance.
First Engineering Group is a leading manufacturer of ultra precision moulds, plastics components and modular manufacturing assembly for high technology engineering applications, headquartered in Singapore , with factories in Malaysia , India and China . The Group has a staff strength of about 2,900 regionally and 600,000 sq ft of manufacturing space with over 430 injection moulding machines. The Group’s customers include major players in diverse industries including data storage, business machine, automotive and healthcare.
First Engineering Plastics (M) Sdn. Bhd., the plant in Penang , Malaysia has recently undergone a thorough audit by DQS Malaysia and has successfully certify to ISO13485:2003. With this achievement, it demonstrates commitment from it management on complying to regulatory requirements.
(front left to right : Mr. Satpal Singh (holding certificate, MR of the ISO 13485:2003 management system, General Manager – Mr. Andrew Tan and QA Manager – Mr. E.C. Khok) with the management team of First Engineering Plastics (M) Sdn. Bhd. after the presentation of the ISO 13485:2003 certificate from DQS