ISO 13485:2016 standard was established by ISO
(International Organization for Standardization) and revised in the year 2016
to authenticate Quality Management System and security in medical devices. The
medical field is witnessing a continuous development in its technologies and
equipment. It is also important for the world to secure safety measures for it.
ISO 13485 can be adopted by any organization manufacturing medical devices irrespective of its shape, size, age, and geographical location. It is currently implemented by the organization in 21 countries.
ISO have adopted the process approach which follows PDCA
act (Plan – Do – Check – Act) cycle which brings in a drive for continued
perfection in the process of organization.
Here
are Some benefits of obtaining this ISO 13485 certificate:
1)
The employees
are able to give stronger commitments to you: When you have an ISO certificate for your
company, the employees working under the roof of your company know how to treat
you and their jobs.
2) Your business turns more efficient: In order
to sustain the quality, thanks to which you win the certificate for your
business, you work harder and improve your company’s performance. This way, you
not only find new ways to bring innovation and creativity to boost the
performance of your company, but also work hard to give it all that it needs.
3) You are able to generate more revenue and
profit: When you constantly work hard, you bang the certificate, which some of
the companies can only dream of. Once your company is certified, you get better
brains to work under your name. When you have intelligent minds working hard to
create and maintain your reputation in the market, you are bound to boost the
sales of your products by increased demand.
4) You can improve your performance on the basis
of the certificate in your hands: If you really want to improve your company’s
performance, you have got to ensure that it gets certified. The reason is
simple — both the situations are interconnected; better your organization,
easier it is for you to get the certificate and vice versa.
5) Customers can trust you easily, if you are a certified name: The moment customers come to know that your company is ISO certified, it becomes easier for them to trust you. Since such certificates are not banged by random companies and there are a lot of efforts that an organization needs to put to get such a certificate, customers respect and value certified companies more than the non-certified ones.
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