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ISO 13485 is a standardization protocol for the development of a quality control framework for medical devices by the International Organization for Standardization. First introduced in 1996. Since then, more than 26,000 organizations have been given ISO 13485 certifications, provided worldwide by approved organizations.
What does ISO 13485 stand for?
ISO 13485 is an internationally recognized proof that the accredited organization has met with all the required provisions for ensuring quality control in the production process of medical devices (also in pre- and post-manufacturing phases). ISO 13485 is a further expansion of the quality compliance standard, i.e. EN ISO 9001.
They are also harmonized with each other in general words. There is, though, one major distinction between the two. ISO 9001 is reactive in nature that it is released and updated only after an entity shows the quality management mechanism has been effectively applied. On the other side, ISO 13485 is a separate standard that simply shows that an organization has put in place an efficient quality control scheme.
Compliance with ISO 13485 throughout your company network will help your business expand the doors to unexploited markets for national and foreign markets. You’ll also reap a whole range of perks, such as sustained credibility in the company
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If you do work in medical industry, you already know that the most difficult obstacle to overcome is to ensure that your ( QMS), as well as medical device, complies with the very rigorous standards that are set by many different standards, including those of ISO 13485:2016. We recognize the value of ISO 13485:2016 certification here at ISo Pros, and truly understand how to apply the respective criteria.
Through certifying your QMS, you can show comfortably that your company’s medical devices have been planned, produced, assembled, shipped, equipped and serviced, all within compliance with all required regulations as well as standards.
ISO 13485 is a globally accepted framework for controlling consistency in the production and selling of medical equipment. Certification to this level indicates that the business is concerned about ensuring the consistency of the goods sold, and that you have taken the appropriate steps (compliance with ISO 13485) to guarantee the quality of the materials.
Benefits of Certificates EN ISO 13485
Organizations that are ISO 13485 accredited would have a greater influence on their procedures and the potential quality development in other aspects of the organization. The EN ISO 13485 certification helps the company to define the QMS in all phases of product realization including design & growth, production, deployment, and post-market monitoring. The benefits of being an organization certified according to EN ISO 13485 are as follows
- Manages consistency over a medical device’s life cycle
- Continuous development of the methods of medical device drug realization
- Ensures medical device safety and continuous improvement of the devices
- Reduces production expenses and improves market share
- Improves customer satisfaction
- Helps to label Medicinal and In-vitro products.
To find out more about how ISO Pros will better secure your organization’s ISO 13485:2016 certification, do contact us today!