Alquest services: Supplier audits for medical device companies
Alquest assists with supplier control through the preparation and audit of supplier quality systems. Supplier audits are used to evaluate suppliers, contractors, and consultants.
Alquest consultants are qualified to audit to the following regulations and standards common to the industry.
- FDA 21 CFR Part 820 Quality System Regulation (QSR)
- ISO 13485:2003
- ISO 9001:2000
Our recent audit experience includes:
- Contract manufacturer – finished device
- Contract sterilization service provider
- Component supplier
- Test lab
- Outsourced manufacturing processes (packaging, sub-assembly, coating, laser welding)
- Consultant services (clinical trial support, document control service provider)