|  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
 
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