MAK Endoscopy has a quality management system to ensure quality, accountability and constant improvement in how we deliver our products. Our system has been certified by government bodies. We are an EN ISO 13485 quality endorsed entity with “CE” mark and an approved facility by Korean FDA & DCGI, Indian FDA.
QUALITY ASSURANCE PROGRAM
Our quality assurance program ensures complete traceability and accountability of materials from procurement to CAPA and R & D.- ✔ Defined raw material and its specification with all the necessary test reports, strengthened quality checks for the supplied raw material and identified approved suppliers.
- ✔ Approved specifications and process sheets to manufacture the product.
- ✔ Process control and regular validation of process which assures that the same process and technology are used to manufacture the product each time.
- ✔ Quality control at every stage of production.
- ✔ In-house (Biological and chemical) Testing facility for every product lot.
Quality is measured by the success of our products and services in helping our customers achieve their goals. Our focus is to exceed our customer's expectations. We measure customer satisfaction through established post market surveillance and vigilance system.
Customer’s Feedback is an important part of improving our quality management system and we encourage all clients and partners to contact us with any suggestions that would help us deliver an even better service.
Our quality assurance program involves continuous improvement of processes and procedures based on the goals and objectives. We continually analyze our procedures for potential improvement. We solicit and introduce measures for improvement at our weekly staff meetings, at "lessons learned" discussions upon completion of a task, and in response to our customer's recommendations.
