Sable has passed GMP！

After spent several months, Sable has passed Good Manufacturing Practices (GMP), audited by Department of Health, Executive Yuan, Republic of China, on March 05, 2015.  Good manufacturing practice (GMP) is the practice required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

  Accomplishing GMP, Sable concerns more what consumer or public needed, following are what Sable received or certificated.

ISO 9001, ISO 13485- Quality Management System

BS 5883, CE marking- Product Quality Testing    

Sable policies and procedures are compliant with the standards developed by ISO to ensure the highest quality product design, development, manufacturing, and servicing. We incorporate ongoing assessment of our Quality Management System as well as an annual compliant third-party audit by SGS Taiwan Ltd., a world-renowned quality testing organization. Sable has held ISO Certification since Feb.2012.  ISO 13485 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 customer requirements and regulatory requirements applicable to medical devices and related services.  The certification issued by SGS Taiwan Ltd. on Feb. 2014. 

All products, Sable swimming goggles, Plano lenses, Prescription lenses, and associated components, are tested by SGS Taiwan Ltd. following to BS 5883 standard protocol.  Sable has informed by SGS that the products are all passed on Jan. 15, 2015.