ISO CERTIFICATION

• TEMPTIME was registered to ISO 9001:1994 by SGS International Certification Services in March 2001 (Certified Number: US2001\2459; issue No.1, March 2001).
  
  
• Successful Surveillance audit was conducted by SGS in September 2001 to maintain registration.
  
  
• TEMPTIME was registered to ISO 9001:2000 by SGS International Certification Services in May 2002 (Certificate Number: US2001/2459; issue No. 2, May 2002).
  
  
• TEMPTIME has maintained its ISO 9001:2000 registration with successful surveillance audits by SGS International Certification Services with the most recent being December 2004.

DEVICE DESIGN RISK ANALYSIS

TEMPTIME uses Failure MOdules and Effects Critically Analysis (FMECA) to assess and manage risk in the design, manufacture and use of our product.

TEMPTIME's Quality System:

• Products are developed under Design Controls
  
  
• Qualification of materials and processes
  
  
• Inspection and test of raw and in-process materials

• Final QC testing of product prior to release

TEMPTIME CORPORATION'S QUALITY MANAGEMENT SYSTEM

For more than four years, TEMPTIME has been successful in an effective Continual Quality Improvement Program.

cGMP

• TEMPTIME is working to make the current quality management system consistent with FDA Quality System Requirement (QSR) 21 CFR 820 (GMP for medical devices).
  
  
• TEMPTIME is committed to the highest level of quality achievable and continues to improve its quality management system by the application of GMP.
  
  
• TEMPTIME has been auditted by the world leading pharmaceutical companies.

All the remarks and observations of the auditors from each company have been taking into consideration and appropriate actions have been implemented.

TEMPTIME is a very open company and encourages customers to visit or audit out company.