Striving for excellence.
Credible, authoritative… simply, certified.
We believe in change as an “engine of innovation” to the point of being an ACTIVE PART of it, looking at every challenge as a fantastic opportunity, promoting it in all its “forms”, such as the Institutional ones.
One of these is, certainly, the SBA – Sterile Barrier Association (of which we are members), an International Association that brings together manufacturers and suppliers of materials and solutions for sterilization and sterile packaging in the medical and healthcare sector, created to:
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Contribute to the development and updating of international regulations;
- Connect (among them) the leading companies in the sterile packaging sector, through events, conferences, seminars and meetings dedicated to technological and regulatory developments;
- Guarantee access to training materials, best practices and sector studies.
A widely shared mission and vision, to which we added our “need” to satisfy (market) demands thanks to universally recognized procedures.
“We chose to BE. We decided to DEMONSTRATE.”.
A “long-standing” choice dictated by our natural predisposition to innovation, to “quality beyond standards”… “to the person, first of
all”. We chose to adhere, with determination and humility, to the ISO13485 and ISO9001 quality standards. Curious: “adapting to quality standards” to “go beyond standards”.
It seems like a contradiction but it is not.
Being a certified company in the flexible medical packaging sector does not only mean “being suitable” or “fulfilling a regulatory obligation”: if on the one hand the company has obtained recognized certifications that attest to compliance with the regulatory, quality and safety requirements required for the production of packaging intended for the medical sector, on the other hand it demonstrates the commitment, the will and the consistency – of the same – in “striving for excellence” respecting the industry standards, resulting credible and authoritative.
ISO 13485 – International standard for the quality management system for medical devices, which guarantees compliance with rigorous safety and traceability requirements.
- Regulatory compliance: ensures that company processes comply with international regulatory requirements for medical devices.
- Greater safety: ensures that products meet high standards of safety and sterility.
- Improved traceability: obligation to document each stage of production, reducing the risk of errors and improving the management of recalls.
- Reliability for Customers and Partners: demonstrates commitment to quality, increasing the trust of customers and health authorities.
- Access to global markets: necessary to supply packaging to medical device manufacturers in many areas of the world.
ISO 9001 – Quality management certification, which ensures efficient and standardized processes.
- More efficient processes: helps optimize production and reduce waste, improving productivity.
- Better risk management: promotes an approach based on the assessment and mitigation of business risks.
- Increased customer satisfaction: guarantees better control over the quality of the products and services offered.
- Competitive advantage: many companies prefer certified suppliers, increasing and enhancing business opportunities. – Continuous improvement: pushes the company to constantly monitor and improve internal processes.
“ZERO ERRORS, WITHOUT DEFECTS, EVERYTHING TRACED.”
Operating within a Quality Management System capable of meeting both standards… is no “small feat” because it means:
- Guaranteed quality – The product is manufactured following controlled and standardized processes, reducing errors and defects.
- Compliance with the requirements for medical devices – If intended for the medical sector, the product complies with the safety and traceability regulations required by ISO 13485.
- Traceability and risk management – Each stage of production is documented, facilitating quality control and the management of any problems.
- Reliability for customers – It is recognized internationally, facilitating marketing in regulated markets.
- Continuous improvement – Production follows a constant optimization approach to guarantee high standards.
We are aware of our ROLE with respect to the entire supply chain… and we (re)know the value of DIRECT and TRANSPARENT COMMUNICATION:
- Greater safety and compliance with regulatory requirements;
- Better reliability of the product and production processes;
- Access to international markets with greater ease but, above all… – Greater trust from Customers and Regulatory Bodies.
Never before has the FORM justified the SUBSTANCE (and vice versa).
Never like in this case… THE PERCEIVED VALUE is the result of an IMPECCABLE STYLE (just like in Surfing).
