Quality Systems Development/Improvement,
Quality Systems Certification: ISO9001 ISO13485 TS16949 AS9001

• Help you develop and implement solid and yet easy to execute Quality Systems that meets the requirement of FDA 21CFR820, ISO13485 and associated regulations

• Help you prepare for ISO9001, ISO13485, TS16949 and AS9001 certification

• Prepare and handle FDA and other 2nd and 3rd Party inspections

o Pre-inspection preparations and trainings

o Back room leader
o Front room translator

o Post-inspection response

o Corrective action plans
o Corrective action executions