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Quality and Compliance

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 Policy: a message from the Chairman

Good morning everyone,

Over the past few years we have addressed quality issues with a more concrete approach than in the past, with the aim of “de-bureaucratising” the process, making it more scientific and measurable, and trying to bring it closer to the goals of a sustainable business that is effective both in its business and in its social role.

The Group’s rapid growth, both internally and externally, and the need to adapt to the latest version of ISO 9001/2015 have given us an opportunity to review the Quality Policy, adapting it to any new risks and business opportunities. All in a strategic context that requires Group companies to integrate more and more with customers and suppliers in their various markets of reference.

IMA Quality System

ISO9001 Certification

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.

Ilapack, an IMA Group company, has obtained ISO 9001 certification. Other Group companies around the world are maintaining their ISO 9001:15 certification.

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.

Compliance with S.O.P.

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.

IT Security Policy

The IMA Group consists of a group of companies producing high-tech processing and packaging machinery for the pharmaceutical and food industries, as well as for industrial automation. The broad business horizon in which the Group operates, both because of the diversification of highly regulated markets (such as pharma and medical, food, automotive, etc.) but also because of the breadth of the geographies involved – 53 production plants spread over 80 countries and more than 30 sales subsidiaries – has led IMA to introduce a central IT management and Information Security policy with the aim of maintaining decisive control over the information transmitted through its digital channels, avoiding the risks of geographical fragmentation as far as possible.  

Within business strategies, a major role is played by the protection of information, being an element of fundamental importance to guide strategic choices and to support business operational processes. Data protection and continuity of processes, according to the Group’s philosophy and guidelines, must be managed through a process of classification, identification of critical issues, assessment of the risk of compromise of confidentiality, integrity and availability, and the definition of the security measures necessary to maintain them within acceptable limits.

This approach stems from the need to better protect the technological know-how and sensitive information produced within IMA and at the same time raise its standards to those that are best practices about the subject; the aim is to produce continuous improvement of internal and external processes and at the same time support its partners and customers in the development of their respective businesses (from small manufacturers to large multinationals from a wide range of sectors).

Not of secondary importance is the role played by the impressive subcontracting chain within IMA’s processes, a chain that the Group itself aims to support in order to generate technological innovation and raise the general level of IT security, keeping pace with the emerging needs required by IMA and the market.

With regard to the protection of the data and information of its Information System, IMA has defined an IT Security Policy in order to pursue its strategic objectives and guarantee adequate levels of security, anticipating/mitigating IT risks on the basis of the following principles:

  • Adopt a ‘’risk-based’’ approach
  • Adopt a data – and user – focused approach
  • Spread a cyber security culture

IMA considers it essential that the measures taken to protect its Information System:

  • are consistent with business requirements and comply with applicable mandatory, national and Group regulations;
  • ensure the aspects of effectiveness, efficiency, while balancing relative costs and benefits;
  • are continuously monitored in order to verify their validity and/or to identify possible areas for improvement

and with this in mind undertakes to:

  • ensure alignment between business and protection objectives;
  • appropriately support, through the correct allocation of resources, the continuous improvement of information protection;
  • promote the creation of a data and information security-oriented culture, through the implementation of information/training initiatives and the establishment of rules to be followed by the various parties (both internal and external);
  • promote, in accordance with its strategic objectives, the continuous improvement of its processes.

GMP, GAMP and Foodstuffs compatible Standards

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.

Environment and Safety

IMA defined an internal control and risk management system, considered as a set of rules, procedures and organisational structures designed to ensure that the business is run in a fair and healthy manner that is consistent with its stated objectives, through a suitable process of identification, measurement, management and monitoring of the principal risks in order to minimise them in terms of staff safety.

The Board of Directors has laid down the main guidelines for the internal control and risk management system. In addition, IMA introduced a set of management systems certified by an independent third party, designed to create value in a sustainable way, shared with all stakeholders, above all human resources.

The standard adopted ( ISO 45001) is the most accredited standard in the world.

IMA also follows the same management approach to minimise the environmental impact of its production cycle.

Product innovation & Patents

Since its inception, the IMA Group has been protecting its innovative machines and devices worldwide by filing Patent Applications and Utility Model Applications. The IMA Group owns more than 1,700 patents and patent applications in the world.