Quality and Regulatory Policy
Last update: March 21, 2019.
BLUEBERRY DIAGNOSTICS INC (BLUEBERRY DIAGNOSTICS) is focused on ensuring that our medical devices meet the requirements and expectations of our customers and users, to ensure compliance with our contractual obligations, legal and regulatory requirements and enable continuous improvement of the Quality Management System (QMS) and its processes.
To achieve this objective, the strategy of company performance is based on the following principles and commitments:
- Ensure excellence in production quality of the manufactured products.
- Understand and meet the needs and requirements of our customers.
- Understand and meet our contractual obligations with suppliers and customers.
- Maintain the effectiveness of the Quality Management System.
- Ensure compliance with legal and regulatory requirements.
The Chief Executive Officer (CEO) is responsible for defining, implementing and maintaining this Quality and Regulatory Policy for which Quality Manual and Quality Management System were established according to the requirements of:
- The UNE-EN-ISO 13485:2016.
- European Directive 93/42/EEC and its amendment 2007/47/EC.
- Transposition of the directive in legislation in Spain RD 1591/2009.
- Requirements of the Competent Authority Health Authority.
The effectiveness of the BLUEBERRY DIAGNOSTICS’ Quality Management System depends on the unconditional support of all our employees. Staff should endorse the concern for quality, understanding the importance of each task performed to achieve the objectives.
The Quality is under the direct supervision of the CEO of the Company, thus, completely independent from the other departments or individuals involved in the production process. The access to the management level will allow the implementation of those procedures, revisions or corrective and preventive action deemed necessary for compliance with the Quality Management System.
The Quality Manager (task assigned to the Chief Quality & Regulatory Affairs Officer of the company), is entitled to propose changes in any activity that may not develop as defined in the Quality Management System.
The CEO establishes the necessary measures to ensure the dissemination of the Quality and Regulatory Policy in all areas of the Organization, pledging to be understood, implemented, reviewed and updated. This diffusion is done through talks with the various heads of the company.
The Executive Management defines the objectives of the company and its key components to achieve the previously points defined in the Quality and Regulatory Policy, awarding each department, the necessary authority and responsibility, by providing required human, technical and financial resources for the elements achievement of objectives.
Sources of Funding and Conflict of Interest (COI)
BLUEBERRY DIAGNOSTICS is 100% funded by the company’s founding shareholders, that means, no government agency, no other private companies or no donations funds have been received.
In the event BLUEBERRY DIAGNOSTICS will receive external sources of funding, such as grants, sub-grants, contracts, subcontracts, cooperative agreements, investors, or advertising and sponsorship revenues, both Mission and Vision, Corporate Social Responsibility, this Quality and Regulatory Policy as well as Advertising Policy will be followed to avoid any Conflict of Interest and, if applicable, this statement will be updated.
Besides, BLUEBERRY DIAGNOSTICS will also disclose any “financial interest” or other personal involvement for all collaborators, or their immediate family, that are related to the individual’s Institutional responsibilities. Financial interest means anything of monetary value, whether or not the value is readily ascertainable. Interests include, but are not limited to: income; honoraria or other payment for services; equity such as stock, stock options or other ownership rights, employment; reimbursed travel or sponsored travel; and services, relationships or positions, even if uncompensated.