Getting an ISO certification is essential for any company to ensure consistent quality and create a legitimate brand that can be trusted. However, the number of companies that are ISO certified in the United States is quite low, especially within the health services industry.
ISO 13485 standard was developed to ensure quality and safety within the medical device industry. Medical devices directly impact the lives of people, whether it is for the better or for worse, which is why they should be precise in the design and manufacturing aspects. ISO 13485 applies to medical device companies that are involved in one or more stages of production, such as manufacturing, distribution and/or design.
Here are some of the key benefits of implementing an ISO 13485 certified quality management system:
Faster Device Production and Distribution Cycle
A quality management system that is consistent and designed in keeping with the best industry practices offers statistical process control, encourages management to think of ways to increase customer satisfaction and ensures waste reduction. As a result, the device production and distribution cycle work faster and the supply chain process becomes more efficient, ensuring better service.
Systematic Process Improvement
It is the responsibility of all the employees in an organization to improve the effectiveness and efficiency of different business operations. However, it is difficult to do that when there is no specific guideline in place that shows how to ensure process improvements and identify inefficiencies. An ISO certified quality management system creates effective communication channels and a common language that can be used to articulate any deficiencies. The QMS system also provides a guideline on improving various processes through tried and tested best industry practices, which results in a systematic process improvement.
Meeting ISO 13485 requirements and getting ISO certified gives companies a competitive edge in the industry. They can market their products and services more efficiently and enjoy the competitive advantage that comes with meeting the set standards of excellence. By ensuring the medical devices meet exceptional quality and service standards, companies can boost their bottom line and ensure the success of their brand.
Get in touch with our ISO 13485 consultant at Barile Consulting Services in Cleveland, OH and get professional assistance in applying for and achieving ISO 13485 certification for your medical device company today!
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