IMA, with the aim of maximizing customer satisfaction and internal and external processes effectiveness, has undertaken since the beginning the way for the implementation of a documented Quality System.
IMA Quality System was awarded the ISO9001 certification in 1997 by SGS, one of the most well- recognized certification bodies in the world. The certification has given more visibility of Quality System to the market, allowing IMA to confronting itself with international market standards.
The certification was not a final goal for IMA, but the starting point and a powerful tool for management and control, in order to decrease inefficiency and optimize processes.
|Quality System includes the entire product lifecycle, from new product concept in Research and Development through sales stages, to the delivery, installation and customer service cycle. Most of the focus is on design stage, the main process for the quality of final product.
During the time, Quality System has been evolved to follow the new Vision 2000 standards and all subsequent updates, emphasizing the process-oriented structure of the system itself. Moreover, several internal projects for process reviewing developed with Business Process Reengineering methods have given precious contributions to the System.
Having set up a Quality System focused on processes allows us to guarantee our customers visibility in the execution of the various project stages that lead up to supplying even highly complex systems within the required timeframe, while maintaining a simple, flexible organisational structure. While working in compliance with S.O.P. for specialist sectors, this structure is capable of staying flexible and ensuring the supply of completely validated systems and a qualified and customised documented support for every single project.
The training level and motivation of technicians who are called upon to perform the various design stages (assembly production, installation, qualification and assistance) plays a central role in our way of working. This allows us to keep customer orientation demand in line with the responsibility of each employee.
IMA, aware of the importance of the specific standards in pharmaceutical and food market, has always tried to anticipate customer requirements and needs extending the range of its Quality System. The result is an integrated system between ISO9001 and market-specific standards, and an high degree of skills on these matters.
GMP, GAMP, foodstuffs compatible standards have been integrated into the IMA Quality System to offer the highest conformity to the sector best practices to our customers.
IMA is currently member of ISPE Italy Steering Committee and Italian GAMP Forum, involved in drawing of standard guidelines related to pharmaceutical machines qualification and commissioning.
Safety of our products is an IMA’s key target, and the way we do it is to assure the full compliance of our machines to the mandatory requirements, such as Machine Directive for EU countries (CE Mark).
The internal technical guidelines are not only restricted to the minimum mandatory requirements, but cover all the areas in which the compliance to an international standard is a must for quality and customer requirements. Main topics are mechanical, hardware and software design, internal and external production processes, until product packing and shipping.
Even in this case, skills and continuous internal training are main goals for IMA because quality of human resources is the best factor to achieve high standards in product quality and for understanding and satisfying customer needs.