Version History
- Version: 1
- Date: 07/10/2025
- Author: Guido Spoto
- Approved by: Guido Spoto
Purpose
The organization promotes production/service-delivery policies that reconcile the needs of economic development and value creation, inherent to the business activities attributable to it, with the needs of respect for and protection of the environment, social responsibility, and the security of information and data.
It further undertakes to comply with applicable regulations, encouraging the spread of a culture of respect for legal principles.
Scope of Application
This document defines the Management System Policy of Infobiotech S.r.l
and sets out its guiding principles.
The policy is designed to be appropriate to the purposes and context of the organization, supporting its strategic mission in the third-party design and development of advanced technological solutions for the scientific and biomedical sector, with a focus on medical devices and Internet of Things (IoT) applications.
The objective is to ensure compliance with regulatory requirements and customer satisfaction.
Normative References
- ISO 13485
- Regulation (EU) 2017/745 on medical devices (MDR)
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
Terms and Definitions
- Top Management: Person or group of persons who directs and controls an organization at the highest level: its responsibility is to demonstrate commitment to the development and maintenance of an effective Quality Management System (QMS).
- Medical Device: Any product, instrument, or apparatus intended to be used for the diagnosis, prevention, monitoring, or treatment of diseases or medical conditions.
- In Vitro Diagnostic Medical Device (IVD): A medical device intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body.
Roles and Responsibilities
- Shareholders' Meeting: Defines the strategic direction and long-term objectives of the company, approves significant company decisions, and oversees the actions of management to ensure their alignment with company purposes.
- CEO: As a representative of Top Management, is responsible for implementing the quality policy, ensuring the availability of resources, and promoting a culture oriented toward continuous improvement throughout the organization.
- Top Management: Establishes and supports the management system policy, ensures the availability of the resources necessary for its implementation, defines the framework for quality objectives, and promotes continuous improvement of the effectiveness of the QMS.
- Management System Manager (QMS Manager): Ensures that the policy is communicated, understood, and applied within the organization, oversees the implementation and maintenance of the Quality Management System, and supports monitoring and audit activities.
Commitment and Objectives of the Management System
The Top Management of Infobiotech S.r.l., represented by the Shareholders' Meeting and the CEO, establishes, implements, and supports this Management System Policy as an expression of the organization's guiding principles.
This policy is designed to be appropriate to the purposes and context of Infobiotech, supporting its strategic mission in the third-party design and development of advanced technological solutions for the scientific and biomedical sector.
The primary commitment is to provide design and development services for medical devices, in vitro diagnostic medical devices, and related software platforms that fully meet customer requirements and applicable regulations, with constant attention to the safety, effectiveness, and performance of the projects carried out.
Fundamental Principles
Top Management is committed to:
- Compliance with Requirements: Ensuring full compliance of the Quality Management System (QMS) with the ISO 13485 standard and with all regulatory and contractual requirements applicable to the services provided.
The importance of these requirements must be communicated and understood at all levels of the organization.
- Continuous Improvement: Maintaining and continuously improving the effectiveness of the QMS through performance analysis, the management of risks and opportunities, and the periodic review of processes.
Top Management promotes an improvement-oriented culture, encouraging the contribution of all personnel.
- Definition of Objectives: Establishing a structured framework for the definition and periodic review of measurable quality objectives that are consistent with this policy.
The definition and monitoring of objectives are described in the procedure "PRO Objectives and Planning for Their Achievement".
- Availability of Resources: Ensuring that the necessary resources are always available, including competent personnel, adequate infrastructure, and a suitable working environment, for the implementation of the QMS and the achievement of quality objectives.
The management of resources is governed by the procedures "PRO Human Resources Management Procedure" and "PRO Asset Configuration, Management, and Disposal Procedure".
Implementation and Review
Top Management has ultimate responsibility for the implementation of this policy.
The Management System Manager (QMS Manager), with the support of the CEO, is responsible for:
- Ensuring that the policy is communicated, understood, and applied at all levels of the organization, in accordance with the methods defined in the "PRO Documented Information Management Procedure".
- Overseeing the implementation and maintenance of the QMS in accordance with what has been established.
- Supporting audit activities and monitoring process performance.
This policy is reviewed at least annually during the management review to verify its ongoing suitability, adequacy, and effectiveness.
This activity is governed by the procedure "PRO Management Review Management" and ensures that the policy remains aligned with company strategies and the evolving context.
The entire Quality Management System is described in the "Medical Device Quality Manual".
Archiving and Updates
This document is managed in controlled format in accordance with what is defined in the documented information management procedure.
It is archived and retained to ensure its accessibility and protection.
The policy is subject to periodic review, at least annually, at the management review, and is updated whenever significant changes occur in the company, regulatory, or strategic context.
Reference Documents
- PRO Objectives and Planning for Their Achievement
- PRO Human Resources Management Procedure
- PRO Asset Configuration, Management, and Disposal Procedure
- PRO Documented Information Management Procedure
- PRO Management Review Management
- Medical Device Quality Manual
