The Quality Policy of Keyon is:

 

To design and develop innovative software systems solutions and software medical devices complying with all the applicable regulatory requirements and meeting the expectations of the interested parties. To release and support such products with the highest standard and care of customer’s satisfaction.

 

General Management uses the quality policy as a means of leading the organization toward improvement of its performance.

 

The organization’s quality policy is an equal and consistent part of the organization’s overall

policies and strategy.

 

In establishing the quality policy, the General Management considers and communicates to the organization personnel:

• the level and type of future improvement needed for the organization to be successful,

• the expected or desired degree of customer satisfaction,

• the development of people in the organization,

• the needs and expectations of other interested parties,

• the resources needed to go beyond ISO 9001 and 13485 requirements,

• the new or changes regulations

• the potential contributions of suppliers and partners.

 

The quality policy is used for continual improvement provided that:

• it is consistent with GM’s vision and strategy for the organization’s future,

• it permits quality objectives to be understood and pursued throughout the organization,

• it demonstrates GM’s commitment to quality and the provision of adequate resources for

achievement of objectives,

• it aids in promoting a commitment to quality throughout the organization, with clear

leadership by top management,

• it includes continual improvement as related to satisfaction of the needs and expectations

• it is effectively formulated and efficiently communicated.

 

As with other business policies, the quality policy is periodically reviewed during the Kelyon

Management review meetings and recorded on the Kelyon review report.

PROCEDURES

The organization is committed all-round in a continuous improvement process in order to attain superior quality objectives. Each organization function is committed towards constantly satisfying the requirements of all the organization’s customer. All the organization’s employees and suppliers are given all the necessary assistance and, where possible, stimulated in order to obtain continuous quality improvement.

 

The products and services supplied and activities performed by each employee must in all ways and at all times meet the requirements which satisfy Kelyon internal and external customers.

 

All the organization’s employees and suppliers undertake to prevent any errors, whether these relate to performance or management, as well as to correct the same, with the full knowledge that prevention is much less expensive than correction.

 

Each organization function manager has the task of:

• establishing and maintaining suitable conditions for contributing towards the design,

development and production of software solutions at a high technological level;

• establishing and maintaining suitable procedures for carrying out the checks necessary for the realization of such products;

• organizing suitable training programs in order that each person is qualified enough to assume his/her own responsibilities;

• ensuring that all applicable laws and regulations are respected

• providing an internal check and revision system in order to ensure that the spirit and the

letter of this policy are maintained.