Medical devices must be precise in their design and manufacture because they impact lives for the better or worse. To reach high levels of reliability in production, quality standards are essential. The benefits of adhering to ISO 13485, which outlines quality management system standards for medical devices, include efficient cycle times, less waste and a reputation for reliability that can permeate throughout the medical industry.
Overview of ISO 13485
According to the International Organization for Standardization, ISO 13485 applies to companies in one or more stages of medical device production. This includes the sourcing of materials, distribution, design, and sterilization, among other functions in the manufacturing life cycle. Quality management system general requirements, management’s responsibility, documentation standards, and product realization are among the subjects covered in ISO 13485. If an organization can prove conformance to the elements of the quality management system, it can become ISO certified.
Faster Cycle Times
Quality and process excellence initiatives utilize statistical process control, waste reduction and systems thinking to increase customer satisfaction. A common result of quality management system deployment is faster cycle times in the supply chain and on the production facility floor. This is because products, processes, and systems are under constant review and re-design when quality management is part of organizational culture. Whether it’s in administration, accounting or purchasing, quality can lead to faster cycle times and better service.
Waste reduction in all parts of the production process is a direct result of building an organization to conform to ISO standards. Identification and removal of overproduction, waiting, excess inventory, defects, and scrap are among the benefits of quality management system deployment. There are also fewer internal machinery failures and fewer customer returns. All of this leads to lower production costs and higher profit margins. Reduction of labor hours allows for cost-savings and the reallocation of resources to value-added activities.
Systematic Process Improvement
Although it’s the responsibility of employees at all levels of an organization to enhance the efficiency and effectiveness of operations, it’s hard to do so without having a common language to describe inefficiencies and process improvements. A quality management system not only creates effective communication channels to articulate deficiencies, but it also provides systematic methods for improving processes through six sigma and lean techniques. Whether it’s through quality auditing or corrective action requests, systematic improvement is a benefit of ISO 13485 certification.
Higher Customer Satisfaction
Quality management systems reduce the cost of non-conforming products, enhancing customer satisfaction. This is true for suppliers of raw materials and other entities in the supply chain, and it can lead to better customer experiences. Given that medical devices have such an impact on people’s lives, there is little room for error or customer returns. For example, statistical process control can help remove special cause variation from the machining process, to create a product that rarely deviates from design thresholds. This can enhance the quality of people’s lives over the long run because medical devices can withstand environmental strains and deliver on their intended purpose.
Meeting ISO requirements enable companies in the medical device industry to better market their products and services. When they become certified, they have met an objective standard of excellence that enhances their competitive advantage in the marketplace. While creating an organization that meets quality management system standards is not a simple process, it is well worth the effort and investment of time and energy. This is because quality is the driving force behind business success and failure.
To remain competitive in the global economy, medical devices must meet exceptional quality and service standards. ISO certification communicates a message to all potential business partners that certified companies are world-class businesses capable of delivering value and long-lasting support, in the fiercely competitive and ever-expanding world of medical device providers.
The prestige and enhanced efficiency associated ISO:13485 are enough to justify being certified. What’s more, the quality of medical devices, along with the profitability of operations and the morale of your employees, will hit new levels of excellence. Process excellence is the key to better business outcomes.