Medical devices Quality management systems Consulting Requirements for regulatory purposes ISO 13485
Medical devices Quality management systems Requirements for regulatory purposes
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Company and Consulenza Integrata are committed to the creation, adoption, implementation and implementation of the Management System.
1) Creation and adoption of the Management System
- Check the activities, processes, roles and functions;
- The establishment of the Corporate Workgroup and definition of the work plan to be followed by mutual agreement between Consulenza Integrata and top management;
- Identification of the Purpose and Scope of the QMS;
- Definition of the structure and responsibilities;
- Support in the choice of the certification body (CB);
- Establishment of company policy and prior identification of targets and related indicators.
Drafting of documented information, covering:
- Procedures for managing the QMS;
- Related forms;
- Manual QMS (if necessary).
To encourage the adoption and implementation of the system, during the course of counseling described above will be carried out action learning, on the job training and coaching specific to the Company Management and the Corporate Functional Managers, pertaining to their duties within the : business processes, objectives and management.
2) Application and Implementation
Support the application of the documents of the Service Management System, training in the field of personnel for the improvement of the documentation of system and process efficiency in view of achieving the same.
4) Internal Audit
During the internal audit of compliance and effectiveness of SGS, the activities will be:
Presentation of the requirements and of the results
Opening of Corrective and Preventive Action needed on the basis of the results of the Audit
Performing the Management Review
Adaptation, where necessary, the QMS.
5) Support during the Audit Certification Body
Assistance, as an observer, in the course of the audit, Document and Surveillance, by the Notified Body and its clarification on the basis of the findings by the Audit and Internal Review Board.
Expected Result: Certification according to UNI CEI EN ISO 13485.
MAINTENANCE IMPLEMENTATION OF QMS
- Audits to check the status of corporate compliance to the Management System
- Eventual document Revision
- System Review
- Assistance, as an observer, in the course of the Supervisory Audit by the Notified Body.
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