(65) 6546 8318 | sales@racer.com.sg

The aspect of manufacturing is not only performance of machinery and equipment, but also depending on human technology and knowledge on international standards & certification.

As part of our Quality Educational System, we promote proactive approach to Quality Assurance & Control improvement through the acquisition of:

  • ISO 13485:2016 Medical Device, Quality Management System
  • ISO 9001:2008 transition to ISO 9001:2015 (March-2017)
  • ISO 14001:2004 transition to ISO 14001:2015 (March-2017)
  • US FDA Establishment Registration 9710609
  • Health Science Authority Medical Device Dealer’s License ES0001536

Six Sigma works on the principle that reducing variation gets to the root of any problem. Lean Manufacturing uses basic improvements to make business processes more effective. We use a set of quality management methods, including statistical methods, and creates a special infrastructure for project within the organisation.

As a Medical Devices Manufacturers Process Validation is an essential part of our system , we do have our in house set of protocol of process validation (IQ, OQ & PQ).