Mölnlycke Health Care has a worldwide reputation for products that are safe, compliant, easy-to-use, reliable and effective – a reputation we secure thanks to our passion for quality and product responsibility.
We strive to continuously improve our performance so that we always meet and exceed the expectations of our customers, the patients that use our products and the regulatory authorities in the markets we operate.
Quality management systems
We have a rigorous process-based quality management system to ensure consistent levels of high quality in our products and throughout our supply chain. There are active internal protocols in place for risk management and internal auditing. Alongside our global processes, each of our sites has a local quality system, as well as staff who are responsible for local quality management and compliance.
We set detailed quality standards for our suppliers – defining what we expect in terms of delivery times, technical specifications and quality. There is a Supplier Performance Management system in place to monitor, improve and control supplier performance and we regularly audit our suppliers.
Certifications and registrations
As a company, we maintain a number of quality assurance certifications and registrations, including ISO 9001, ISO 13485 and the Medical Device Directive. We are regularly audited by our notifying body, the BSI, and regulatory authorities in our markets around the world.
Code of Conduct
We have a global Code of Conduct, which governs the high ethical standards we expect of our staff. Our Supplier Standard covers what we expect of our suppliers, in terms of human rights, the environment and health and safety.
Ms. Ooi, a Product Integrity Manager in Malaysia, is a stickler for quality. She makes sure we test every single Biogel® surgical glove for holes by air inflation. It’s thanks to people like Ms. Ooi that Mölnlycke sets the standard in surgical glove protection. Watch Ms. Ooi in action below.