Logo-ISOPlan   Consultancy for medical and healthcare companies

                                                                                                    An international pass for the manufacturer

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GMP  FDA, GCP GOOD CLINICAL PRACTICE, QUALITY MANAGEMENT SYSTEMS ISO 13485 e ISO 9001

ISOplan 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:

  • 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.
   ISOplan  is particularly expert in providing the following Quality Manuals :
  • Medical devices manufacturers
  • Healthcare organizations
  • Cosmetics companies
  • Food companies