Quality
A reliable partner for high-quality solutions in Life Science
Quality of Hammarplast Medical
At Hammarplast Medical, quality is a central part of our business. Our facilities in Bredaryd, Tallinn and Lidköping are certified according to ISO 13485 and ISO 14001, which ensures that we meet high standards in medical technology and environmental management. The Lidköping site is also certified to ISO 9001. Our certificates are issued by RISE.
Regulatory compliance and MDR
Our products are covered by an MDD certificate from Intertek Semko AB, and through strategic planning we have secured an extended validity under the MDR transitional rules until 2028. At the same time, we are actively working to adapt to the MDR (EU 2017/745 ) to ensure continued compliance and security for our customers.
Cleanroom production and international standards
We produce under strictly controlled and clean conditions, both in ISO Class 8 GMP Class C cleanrooms and in other customized production environments. Our facilities are registered with the FDA, which means we meet the requirements for export to the US. Whatever the manufacturing environment, we ensure the highest quality to meet the stringent requirements of Life Science.
Continuous improvement - part of our culture
We are constantly striving to improve our processes and meet customer needs, while ensuring full compliance with regulatory requirements. Each of our employees has a personal responsibility to maintain quality in all work performed, making us a reliable and long-term partner in medical technology.
Our ISO certifications
ISO 13485 - Quality standard for medical devices
ISO 13485 is an international standard for quality management systems in medical devices. Our operations in Lidköping, Bredaryd and Tallinn are certified to this standard, ensuring that we meet regulatory requirements, risk management and product traceability.
For our customers, this means peace of mind that our products are developed, manufactured and distributed to the highest quality standards. Through strict adherence to ISO 13485, we are constantly improving our processes for increased safety and reliability.
ISO 14001 - Environmental management and sustainability in focus
ISO 14001 is an international standard for environmental management systems that helps companies systematically reduce their environmental impact. Our operations in Lidköping, Bredaryd and Tallinn are certified according to this standard, which ensures that we work actively with sustainability and continuously improve our environmental performance.
For our customers, this means working with a manufacturer that takes responsibility for the climate and the environment, with a clear commitment to combining high-quality production with sustainable solutions.
ISO 9001 - Quality management for efficiency and reliability
ISO 9001 is a global standard for quality management systems that ensures efficient and customer-focused processes. Our Lidköping facility is certified to this standard, which means that we work systematically with quality assurance, risk management and continuous improvement.
For our customers, this means reliable deliveries, shorter lead times and high product quality. This certification is proof of our commitment to meeting and exceeding customer expectations.
Our quality policy - Our drive for excellence
At Hammarplast Medical, quality is the foundation of our business and a key factor for our long-term partnership in the Life Science industry. Working closely with our customers, we develop innovative, user-friendly and safe polymeric products and services that contribute to high patient safety and reliability.
We are a long-term and reliable partner who, in cooperation with our customers, efficiently develops and manufactures customized polymer products and services in Life Science that contribute to high patient safety.
With a focus on competence and stable processes and through continuous improvements, the effect of the management system is preserved and thereby we ensure that both customer and other relevant requirements are met.