Dear Reviewer,
Please find attached facility reports for Kawasumi Laboratories (Thailand) (#22446, #33083, #38519, #39451) Surveillance Audit on August 1-5, 2016 for your review and release audit registration.
- Applicable Standards: EN ISO 13485:2012/AC:2012 and Medical Device Directive 93/42/EEC Annex II.3.
- Total on-site manday for 4 facilities is 13.5 mandays by including Technical File review.
Please note that this is monitoring audit Mr. Noriyuki Ohta is monitored by Mr. Parivat to keep his lead auditor
Should you have question and need any additional information, please let me know. Thank you very much.