quality management system

The Management of Clover Orthopedics sets out a Quality Policy, detailing the objectives and the commitments undertaken in view of corporate strategies, the obligation to meet applicable regulatory and mandatory requirements, and to continuously improve the Quality Management System’s performance, compliant ISO 9001:2015 Quality Management Systems, ISO 13485:2016 Medical Device – Quality Management System, Medical Devices Regulation (EU) 2017/745.

The Quality Management System is then able to guarantee that the quality of services and medical devices:

• Satisfy the customers’ expectations (patient, surgeons, Clinique or dealer), even if not explicitly stated, in efficacy and efficiency.
• Are compliant to the norms and product requirements regarding pharma or medical devices.

The evolution of the company culture aims to the supreme quality of the company and it is headed to the continuous improvement of itself.

Clover has then set a Quality Management System, involving all the employees, that regards its application to all the activities of the productive cycle, from the development of the medical devices to their pace in the market and their use.

The Quality Policy is established/revised during the annual Management Review, during which they determine whether it is in line with the goals of the organization; when necessary, changes are made to said policy. Quality Policy is included in the annexes of the management review.

To reach all these objectives, the Management must show leadership and effort with respect to the Management System of Quality through its sponsorship, development and support and it assure that:

• It will analyse its own organization and environment.
• It will plan the improvement strategies, by incorporating the management system requirements regarding the company business.
• It will engage all the employees, improving their awareness and leading and supporting the people to make them part of the efficacy of the system of management, through constant information and formation activity headed to a professional improvement and to a better quality-management and risk prevention of the company business.
• It will analyse and take in consideration the requirements and the expectations of relevant stakeholders (mainly customers, suppliers, partners, employees, public and private realities, notification bodies), by including them in its own system of management as mandatory or voluntary requirements.
• It will organise a management structure headed to build what described in the previous paragraphs.
• It will show the necessary human resources, working environments, infrastructure, machinery and instruments.
• It will apply a constant control of the compliance of the requirements defined in the management system documentation.
• It will periodically verify the compliance to the System of the company policy and make the technical and organization changes that are necessary to reach this goal.

Projects and activities are managed in an agile way and are divided into 4 stages: start, planning, execution, monitoring.

The Management of Clover Orthopedics ensures the dissemination of its Quality Policy:

• by making it available to the management software of company Quality;
• by ensuring that the personnel of Clover Orthopedics are informed, in a controlled manner, of the issue of a new revision;
• by distributing the Quality Policy, in a controlled manner, to suppliers and/or customers concurrently with the distribution of the present Manual.

In accordance with Regulation (EU) 2017/745, the Management identify in the Organization Flowchart (MSQ_DOC 1 – Organigramma) the person assigned with the role of Person Responsible for Regulatory Compliance, whose duties are listed in Mansionario PRRC. Proof of assignment and acceptance of this role is given by means of assignee’s signature on MSQ_DOC 2 – Affidamento incarico.