As a Design and Manufacturing company that is certified to the ISO 9001:2008 and ISO 14001:2004, we are also among the first to attain the ISO 13485:2003 (International Standard for Medical Devices) certification.
Racer’s quality assurance division is equipped with state of the art measuring equipment capable of inspecting the precision dimensioning of our customer’s products assuring they stick to specifications.
Racer establishes its quality framework based on the concept of training, cost-of-quality, mistake-proofing, analysis of defects, prevention and internal audit. All parts and its process are controlled with a Quality Inspection Plan and engaged advanced statistical process techniques such as Process Validation/APQP, Design & Process FMEA and others SPC tools like Process Capability Studies (Cp/Cpk), Control Charts (X-Rbar) and Pareto Charts.
In Racer, we believe Quality is a must to ensure its manufacturing capabilities.
a. Product Certification
b. Product Certification Compliance
c. Process Validation (IQ/OQ/PQ)
Lists of ISO Certifications:
~ISO 9001:2015 Quality Management System certified since 1998.
~ ISO 13485:2016 Medical Device Quality Management System certified since 2005.
~ ISO 14001:2015 Environment Management System certified since 2006.
~ FDA Establishment Registration: 9710609.
~ UL Code: H1431.
~ GMP & 6 sigma procedures.
Awards:
Singapore SME top 1000 Companies 2012
Good Performance 2010 from Siix Singapore
Good Quality 2011 from Siix Singapore
Supplier Excellence 2000, from Seagate
Singapore Outstanding Enterprise Award 2012
Singapore Brands Award 2012/2013
Singapore Excellence Award 2011/2013
