Our Quality
Quality is fundamental part of Helapet and is embedded into all of our processes, products and services. Our planning, monitoring and assessment procedures ensure that we consistently meet regulatory requirements and continue to enhance the integrity and value of our products. We carry out regular quality inspections supported by stringent testing to deliver a comprehensive level of assurance across our diverse product portfolio.
Operating ISO Class 7 and Class 8 rated cleanrooms, Helapet implement a certified quality management system to ISO13485:2016 standards and are regularly audited by our notified body. Our in-house manufacture, filling and packaging of essential sterile and cleanroom ready consumables for the healthcare industry, means we do not compromise when it comes to the safety, traceability and sterility of our products.