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Quality Management System according to ISO 9001

The Quality Management System (QMS) is a system of control, that is a set of activities designed to check that the results of a given process comply with established expectations. The organization of a QMS is based on the documentation that defines the activities implemented by the company for quality assurance.

The norm UNI EN ISO 9001 is a standard acknowledged as harmonised technical norm for Quality Management Systems. It is based on a approach by systems, on a careful analysis of the specific contexts and on the risk assessment.

Together, these three approaches leads a company to face their workload more effectively and to better funnel their resources.   Obtaining the ISO 9001 certification is a process that can be complex sometimes, often creating difficulties to companies and bodies, but bringing a global improvement to the company itself.  

Di Renzo Regulatory Affairs offers advice to lead companies in the compliance with the requirements to obtain the ISO 9001 certification. Di Renzo Regulatory Affairs has highly qualified staff dedicated to quality services, and able to assist the companies in the following activities:

  • Advice for the setting up and maintenance of the Quality Management System according to the ISO 9001
  • Support in the drafting of the Quality policy and of Standard Operating Procedures (SOPs), defining in details, for each activity, all required actions, responsibilities, operative methods and media, controls and registrations
  • Preparation of the data recording system, whose purpose is to provide objective evidence of  the activities performed, controls carried out and results obtained  
  • Assumption of the role of Quality Assurance for ISO 9001 systems
  • Support in the organisation and management of in-house audits
  • Support in the management of non conformities and corrective and preventive actions (CAPAs)
  • Audits at companies and suppliers
  • Contacts with Certification Bodies
  • Control and update of the QMS documentation