Acitivities for ISO 13485 Certification

Due to the different criticality of the reported findings, a varying number of stakeholders across all management levels of the customer have to be addressed per topic. While processes like IT security, data protection and training are clearly assigned in the organization, the assignments for document control or CAPA/Complaint handling are more fuzzy. During the projects execution the customer agrees with a better structuring of its own QMS and the creation of different standard operation procedures including the respective templates and work instructions. Additionally, several document management systems are evaluated and checked against the customers needs. Introducing the best value tool with support from PTA is the closing step of this project.