The design and manufacture of medical devices must be precise since they impact lives for the better or worse. Quality standards are essential to reach high levels of reliability in production. Efficient cycle times, less waste and a reputation for reliability that can permeate throughout the medical industry are only a few of the benefits of adhering to ISO 13485 which also outlines the quality management system standards for medical devices used by medical professionals.
Overview of ISO 13485
ISO 13485 applies that consist of one or more stages of medical device production as stated by the Internation Organization for Standardization. The functions include the sourcing of materials, distribution, design, and sterilization, among other functions in the manufacturing life cycle by the ISO 13485. Among all the subjects covered in ISO 13485, it includes quality management system requirements, management’s responsibility, documentation standards, and product realization. An organization can become ISO certified if they can prove conformance to the elements of the quality management system. The following are the benefits of being ISO 13485 certified.
- Faster cycle times. Statistical process control, waste reduction, and systems thinking to increase customer satisfaction are few of the things utilized by the quality and process excellence initiatives. Faster cycle times in the supply chain and on the production facility floor are the common results of quality management system deployment. Faster cycle times and better service can go through a quality whether it is in administration, accounting or purchasing.
- Less Waste. The direct result of building an organization to conform to ISO standards is the waste reduction in all parts of the production process. Among the benefits of the quality management system, deployment include identification and removal or overproduction, waiting, excess inventory, defects, and scrap. There are also fewer internal machinery failure and fewer customer returns such that it all leads to lower production costs and higher profit margins of the production.
- Systematic Process Improvement. It is hard to enhance the efficiency and effectiveness of operations although it is the responsibility of the employees at all levels of an organization without having a common language to describe inefficiencies and process improvements. Having a quality management system does not only create effective communication channels to articulate deficiencies but also provides systematic methods for improving processes through six sigma and lean techniques.
- Higher Customer Satisfaction. The cost of non-conforming products is being reduced through quality management systems, thus, enhancing customer satisfaction. These products can enhance the quality of people’s lives in the long run due to medical devices that can withstand environmental strains and can deliver on their intended purposes.
The convenience, prestige, and enhanced efficiency linked to ISO 13485 are enough reasons to justify getting certified. To remain competitive in the global economy, medical devices in the medical industry must meet exceptional quality and service standards, while iso 13485 certification malaysia proves them that they are since it communicates a message to all potential business partners.