GMP FDA, GCP GOOD CLINICAL PRACTICE, QUALITY MANAGEMENT SYSTEMS ISO 13485 e ISO 9001
experts provide consultancy for the certification through all the the steps
required by the FDA GMP, GCP, ISO 13485 and ISO 9001 international standards.
The projects includes:
ISOplan is particularly expert in providing the following Quality Manuals :
- Company analysis, Quality Management System project, Initial training.
- Quality Manual, Quality Objectives, Basic Forms, Procedures (mandatory on 6 items), Basic Records, Work Instructions.
- All Forms and Documents, Records, Management Review, Internal Audit
- Audit assistance during the audit of the certification body.
- Medical devices manufacturers
- Healthcare organizations
- Cosmetics companies
- Food companies