ISO 13485 Certification
A Quality Management System Certification for Medical Devices
There is no doubt that the medical device quality can directly impact the safety of the patients and other people. This is the main reason why the regulators require the medical device manufacturers and suppliers to establish a quality management system that can be audited and verified.
There is one thing common in all medical device manufacturers: they can benefit a lot if they are designed and manufactured with the ISO 13485 alignment. ISO 13485 international standard is one of the most widely used methods of measuring the quality management system of the medical device manufacturer, and therefore, it is crucial for them to fulfill the related regulatory requirements for this international standard.
What is ISO 13485?
ISO 13485 is known to be among the most common of the medical device Quality Management System regulatory standard that is entirely focused on maintaining the effectiveness of the QMS and meeting the regulatory and customer requirements. The main goal of ISO 13485 is to offer a globally harmonized QMS according to the international markets.
All the guidelines for maintaining an effective QMS defined in ISO 13485 are aimed at the design, manufacture as well as distribution of medical devices that are effective. Although it is a regulatory requirement, ISO 13485 compliant QMS is helpful for the manufacturers to minimize variation, which offers various economic benefits in the efficiency of the general process.
Why do you need ISO 13485?
As ISO 13485 is an international standard for the medical device industry Quality Management System, the thing to be noticed is that it has already been tested and proven in the market. Those organizations that have been able to achieve this certification can give proof to their customers that their organization complies with all the regulatory requirements and best practices.
When you get your company ISO 13485 certification, you will start to notice that there will naturally be much better control over all of the processes, while you will also witness continuous improvement. Another significant edge is that you will be driving a continual return on your investment.
Benefits of ISO 13485 Certification
When your organization is able to meet the ISO 13485 standard, you can show your clients that quality is taken very seriously by you, and there is a proper system in place to ensure it. This way, your QMS can become a powerful marketing tool and can indeed translate to more opportunities.
There are some quality management principles that have built ISO 13485, and customer satisfaction is at the top of these principles. It is possible to achieve this by assessing the requirements and expectations of the customers and paving a way to meet them. Customers are always aware of their needs, and they may not entertain a supplier who is not certified.
ISO 13485 is a management principle for continuous improvement, and when it is adopted in any organization, then its management will surely try to find different ways to improve the way things are done. With the help of the systematic processes, many problems will be reduced, and the staff will spend less time making mistakes and more time in offering quality services.
When employees are directly involved in finding ways of improving the processes, the chances are that they will give great insight and offer their best for the company’s success. Therefore, when the employees become engaged, this can surely lead to increased productivity and efficiency.
How can UQSR help you with ISO 13485 Certification?
UQSR is one of the leading global management certification bodies for quality management systems, including the systems in medical device manufacturing. Established in 2012, UQSR Global Private Limited has become India’s top ISO certification service provider offering top-quality certification services. They are accredited to issue ISO 9000, ISO 22000, ISO 13485, as well as many other international standard certifications. Their team of professionals has achieved recognition for their services as they cater to each industry segment, whether it is a medium-sized organization, a large corporation, or a government department.
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