KL-Kepong Rubber Products Sdn. Bhd. and Sanctuary Health Sdn. Bhd. certified to the ISO 13485:2003
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customers' and applicable regulatory requirements.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
DQS, being one of the few Notifying Body recognized by EU, FDA from USA , Health Canada and CCC from China recently certified 2 organisation in Ipoh , Perak.
After a series of comprehensive certification assessments, DQS is pleased to deliver the ISO 13485:2003 certificates to KL-Kepong Rubber Products, one of the export glove manufacturer and Sanctuary Health who manufacture dental dams for orthodontic procedure.
Certifying to ISO13485:2003 is a concrete evidence to demonstrate their commitment to produce better product while optimizing their resources as well as their commitment in compliance to regulatory requirement that impose by certain market.
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