Quality « Nical.com



Quality

                                                                        

  

ISO 9001:2008 ISO 13485:2003 EC CERTIFICATE

CCD N23 UL CERTIFICATE

CCD N11 UL CERTIFICATE

FDA 510K NOTICE

 


The management of Nical S.p.A defines and documents its commitment to quality and ensures the implementation of quality measures with determination and continuity. In particular, NICAL S.p.A. has undertaken to establish a system of quality management according to ISO 13485:2003 and ISO 9001:2008 defining the quality policy, organizational structure, responsibilities, and resources needed.

NICAL management has prepared this document for its company QUALITY CONTROL policy:
a) it pertains to the needs of Nical S.p.A and its marketplace;
b) highlights the commitment of NICAL in meeting the quality requirements established to maintain the effectiveness of quality management and improve the performance of the company;
c) take into account the safety requirements of medical devices designed, manufactured and marketed;
d) provides a structural framework for the identification and review of performance targets;
e)to maintain at all level Nical S.p.A's quality controls and ensure it is understood and followed by all employees;
f) is periodically reviewed and revised if necessary, to ensure its continuing success.

The management of a corporation requires a careful assessment of production processes, their cost and market demands in order to ensure competitiveness and positive financial benefits.This assessment has led the NICAL management to establish the system of quality management according to ISO 9001:2008 and ISO 13485:2003, defining the quality policy, organizational structure, the objectives of individual processes, responsibilities, and resources.Continuous technological innovation, quality, technical capability and service are the primary means to compete in the market: they are therefore the basic elements of corporate strategy by Nical S.p.A.

THE COMPANY'S MISSION STATEMENT

To represent the highest point of reference for manufacturers of diagnostic equipment used in radiology, constantly improving the
quality of examinations

This perspective, is part of the quality policy, whose primary objective is to satisfy all parties interested in NICAL's manufacturing practices in accordance with the law and regulation. This means:

► Supply OEM manufacturers with compatible radiological devices , technologically advanced, reliable and economically competitive


► Radiological devices that are clinically effective, easy to use, and able to bring maximum benefits to the patient.


The task of Nical S.p.A. is to combine these mutual quality controls.

To implement its Quality Management System Nical S.p.A. is committed to:
- Research and continually develop its products, analyzing comprehensively the risks and benefits, and to provide the best of technical and clinical solutions..
- To meet customer requests and marketplace demands. This is achieved by implementing all appropriate initiatives and opportunities to prevent any possible complaint, both during the negotiation phase and during product use, structuring and strengthening the system of checks and prevention of defects and analyzing data received back from our market .
- To provide a quality product tested in compliance with the laws and standards set. This is achieved by: ensuring that the process takes place under controlled conditions and in environments that ensure the product requirements. In accordance with applicable regulations, internal specifications, and ensuring that all products / services supplied are in accordance with the requirements. Products meet the identified requirements by taking into account the best value for money and ensuring full compliance with the requirements of the regulations.
- Continue to develop, at all levels in the organization, the corporate culture of quality. This will ensure continued effectiveness of the implemented quality system and a striving for excellence. Quality is a responsibility and a goal of management and staff. Everyone must create the conditions necessary to achieve these objectives, creating a participatory environment that encourages dialog, thus maximizing the skills and experiences of all team members.
- Ensure the implementation of activities aiming to continuously improve both product and business processes. In compliance with safety requirements for medical devices. This is achieved by analyzing information and data which allows them to determine: the targets and indicators against which to measure the quality of the process of continuous improvement. The means and resources to transfer the benefits of our quality system to the customer. These continual improvement activities must always be applied for the safety and efficacy of our products.
- Ensure the protection of the environment and health of its staff. This is achieved through compliance with laws and regulations and the adapting of their systems and processes to reduce environmental impact and ensure the safety of staff within the company.




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