Quality Policy

Silcotech‘s Quality Management System is accredited to ISO9001:2015 and ISO13485:2016 standard for manufacturing system. Our materials are compliant to Rohs and Reach requirement as well as the Underwritten Laboratory Regulation。The material testing according to ASTM and ISO standards.

For Medical Components and Devices Manufacturing
– Our materials are compliant to FDA standard; 21 CFR 117.2600 (Rubber Articles) requirement and Biocompatibility test according to ISO 10993-1.
– Environment and microbiological control.
– Our ISO Class 8 cleanroom ensures every unit manufactured meets the necessary criteria.
– Specific requirements for documents, validation of processes and test method preparation for sterile medical devices and components.

Quality System: ISO9001:2015

  • Certified on May 27 2010
  • KGS Certification Sdn Bhd

Quality System: ISO13485: 2016

  • Certified on July 27 2016
  • KGS Certification Sdn Bhd

Quality Plan

Incoming Inspection

  • Incoming ( Raw Material )
  • Incoming Compound

In Process Inspection

  • Molding
  • Lamination (Only applicable if the process is visible)
  • Cutting
  • Final Packing

Outgoing Inspection

  • Outgoing

Quality Control

  • Incoming Inspection
  • In process Inspection
  • Outgoing Inspection
  • – Sampling Plan AQL 1.5%, C=0

( Based on customer requirement )

Quality Control

  • SPC ( e.g X-bar chart)
  • CPK study ( Process Capability Index )
  • FMEA ( Failure Mode and Effect Analysis )
  • Gauge R&R

Measuring Equipment

Non Contact Measuring System

Sealed Die Rheometer

Tensile Tester

Chamber Test

Durometer Tester (Shore A)

Pull Tester