Getting ISO 13485-ISO Cincinnati-ISO PROS #2

Getting ISO 13485 Certified in Cincinnati, Ohio (OH)

As a sensitive medical industry is, it needs to have very strict regulations when it comes to its medical devices. It is the safety and reliability of these devices that can determine the difference between life and death, hence the need to comply with the relevant regulations and ISO 13485.

ISO 13485 is an international standard for setting medical device quality management. This is a generic standard that applies to all industries regardless of the size, but its implementation still remains voluntary according to the International Organization for Standards. However, many countries have made it mandatory with plans in the United States Underway.

What do you need to know about ISO 13485?

  • It applies to every industry no matter how big or small it is.
  • It is not a standard that defines the quality of the product. Rather, it defines requirements for different processes that will result in products and services of an acceptable standard.
  • The certification is awarded to an organization and not an individual.
  • It is not mismanaged as a membership group, that is, you don’t become certified for joining ISO 13485, but you get certification for meeting minimum requirements and proved your ability to maintain the standards.
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What is 61+64?

Conditions for ISO 13485 certification

For your organization to get certified, you need to meet the following conditions:

Implement a quality management system according to the ISO 13485 standards

Apply for certification from an accredited body to conduct an audit on your organization to see the extent by which you comply with the standards. If everything goes well, that is, their certifying body did not find any nonconformities, then a certificate is issued. This is not a permanent certificate as it has a limited validity period of not more than 3 years.

The last requirement is your continual conformance to ISO 13485 standards since you will need re-certification every three years. Keep in mind that you can easily lose your status as an ISO certified organization if you fail to meet the minimum requirements of ISO 13485 during the recertification process.

Where to source ISO 13485 implementation and certification services?

Now that you are ready for the certification, how do you go about that? Don’t worry if you are a resident of Cincinnati or any other city in the Ohio State. ISO Pros is a certified and accredited company with experienced auditors who can help you out. We have helped many organizations in this state to comply with very many different ISO Standards.

When you choose to certify your organization with us, you are better placed to have it successful no matter what. Our team is not made up of critics but professionals who know how to better handle their work. This is evident in the way we report any nonconformity and our recommendations on what you can do to correct them. It happens more often than not to get nonconformity issues with different organizations. Do not panic should that be the case with yours as we are here to help you. Just contact us.