Evidence of adherence to legal, regulatory and contractual requirement
The regulators in major world markets (European Union, North America, Japan and China) have expressed an explicit regulatory requirement in their regional laws and regulations by which manufacturers must abide for devices placed at their market. ISO 13485:2003 is the best benchmark for quality and regulatory compliance.
The new ISO 13485:2003, formatted and including most elements of ISO 9001:2000, was published in July 2003, plus particular requirements of business sector replaces ISO 13485/88:2001 which officially withdrawn on the 15 th of July 2006.
GMP Medicare, one of the glove factory that produces sterile gloves, powdered and powder free examination glove recently has undergone an audit by DQS and has successfully obtained ISO9001:2000, ISO13485:2003 and CE Mark certificates.
The main reason GMP choose DQS to be their certification partner is because DQS is one of very few notifying body which able to offer ISO 13485:2003, CE Mark, CMDCAS and FDA Inspection with local competent auditor.
(From L to R) GMP General Manager Mr. KL Tan, DQS Technical Assessor Mr. Brauening, GMP Managing Director Mr. Michael Ch’ng and GMP QA Manager Ms. Siti Khatijah received certificates from DQS representative.
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