Scanbur.eu / Company Profile / Governing Standards
Governing Standards
Scanbur
- ISO 9001:2001
- ISO 9001:2008
ISO 9001 gives the requirements for quality management systems, is now firmly established as the globally implemented standard for providing assurance about the ability to satisfy quality requirements and to enhance customer satisfaction in supplier-customer relationships.
Tecniplast and IWT
- ISO 14001
ISO 14001 gives the requirements for environmental management systems, confirms its global relevance for organizations wishing to operate in an environmentally sustainable manner.
Steris
Maintains strict quality standards regarding the safety and supply of products, and its governing standards include:
- FDA 21 CFR 820 – Quality System Regulation
- ISO 9001:2000 – Quality Management System Requirements
- ISO 19011 – Guidelines for Quality Auditors
- ISO 13485:2003 – Quality System for Medical Device
- MDD – Medical Device Directive – European Legislation
- CMDR – Canadian Medical Device Regulation
- TGA – Australian Therapeutic Goods Administration
- PMDA – Japan Pharmaceutical and Medical Devices Agency
- EPA – U.S. Environmental Protection Agency
- EChA – European Chemicals Agency