Iso13485: A Requirement For Maintaining Quality

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If you are a manufacturer of medical devices and want to expand your business at a global level, then you need to get ISO 13485 certification. This particular standard has been developed specifically for the designing and developing of medical equipments. And the main emphasis of 13485 standards is on maintenance of quality at all the stages of making if devices.

Now one would be wondering, if it is requirement by need or requirement by choice. The answer lies in the fact; medical industry needs the safety aspect in all their devices. And since this particular standard is an assurance of quality, the medical industry can trust the 13485 certified company. Therefore, every medical equipment manufacturer needs to adopt this standard to the certification.

But it is not easy to get the 13485 certification. You have to make a rigorous implementation of an effective quality management system in all the phases of product i.e. from product planning to product development till the time it is delivered. And the standard requires certain essentials to be followed strictly which include:

Creation of a quality manual ...
... based on the requirements of medical equipments.

Awareness of need of quality among all the employees of organization.

Implementation of all the procedures, rules and regulations.

Once all the above stages are complete, and the implementation is successful, then you can invite 13485 registrar to conduct an audit to check if all the compliances are correct. If the registrar gives you a clean chit, he will recommend your organization for the certification. Therefore, it is necessary for you to ensure that your organization has successfully implemented the QMS.

ISO13485 is recommended not just to ensure quality but it also offers certain benefits to your organization. First of all, due to its world wide acceptance you can easily implement it without making any modifications in the standard procedure. Secondly, operating costs are significantly reduced due to the systematic and organized working of organization. Thirdly, by implementing the standard, an organization put up an effective display it’s commitment towards quality which creates a positive impression in the eyes of customers.

Another standard which makes the organization fit for the customers choice is ISO 14001 which basically requires the organization to follow a QMS based on the set of rules for the protection of environment. Due to the growing awareness about environment conservation, the 14001 standard ahs become a requirement for organizations to display their fulfilment of responsibility towards environment.

These standards are really helpful in maintaining the quality levels in the organization so that they seek global acceptance and become a preferred choice of all. So they are recommended to all the organizations who want to get associated with medical industry.

For more information about ISO13485, please visit www.qualityassociates.org