Usman Suwandi
My blogs
| Gender | Male |
|---|---|
| Location | Bekasi, Jawa Barat, Indonesia |
| Introduction | Pengalaman Kerja : I. PT TÜV NORD Indonesia (member of TÜV NORD CERT GmbH, Germany) : Certification Body, testing and calibration laboratory (sejak 2003) 1. Vice President – TÜV NORD Indonesia 2. Lead auditor for : • MDD 93/42/EEC – Medical Device Directive; • ISO 13485 - Medical Devices — Quality Management Systems — Requirements for regulatory purposes; • Medical Device Regulation (MDR) 2017/745; • EN 46001 – Quality systems – Medical Devices – Particular requirements for the application of EN ISO 9001; • ISO 9001 – Quality Management System; • ISO 14001 - Environmental Management System; • ISO 50001 – Energy Management System; • HACCP and ISO 22000 – Food Safety Management System; • ISCC – International Sustainability for Carbon Certification. 3. Pengalaman Audit /trainer berbagai sistem manajemen dan di berbagai perusahaan di Indonesia maupun di luar negeri seperti Tiongkok, Taiwan, Thailand, Malaysia, Philiphina,Vietnam, Singapore, Kamboja, Arab Saudi. |
| Interests | Pengalaman Kerja : II. PT TÜV International Indonesia (1999 - 2003) Lead auditor for : •MDD 93/42/EEC – Medical Device Directive •ISO 13485 - Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes •EN 46001 – Quality Systems – Medical Devices – Particular requirements for the application of EN ISO 9001 •ISO 9001 – Quality Management System •ISO 14001 - Environmental Management System •HACCP and ISO 22000 – Food Safety Management System III. PT Kalbe Farma : Pharmaceutical Company (1986 – 1999) •Staff of Pharmacology •Head of Microbiology laboratory •Analytical & Standardization Manager and Research Manager. |