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.
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.
Less
Waste
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.
Higher
Prestige
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.
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.
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