Getting ISO 13485 Certified-ISO 9001 Fairfax VA-ISO PROS #46

Getting ISO 13485 Certified in Fairfax, Virginia (VA)

When your organization is tagged as certified, it means that you have implemented a quality management system that complies with the ISO 12345 standards. But what are these standards? ISO 123485 specifies the minimum requirements for a quality management system that is specific to the medical devices.

All the medical devices that are designed, manufactured, and distributed across the globe have quality requirements, and that is what ISO 123485 quality management system aims at achieving in your organization.

ISO 123485 is a standalone document that can be used indecently in the medicine industry. However, it borrows a lot form ISO 9001, which is a global standard for a quality management system. This standard is voluntary, but it has been made compulsory in other countries around the world.


What are the basic steps to ISO 123485 certification?

We can say many things about this global standard. However, because of time, we 1are going to end our discussion there and move straight to the steps that you need to take for successful certification. Each of the steps that are listed below has many procedures that need to be followed, but once again, we are not going into each of them. You can always contact ISO Pros if you need to get more information about each of these steps.

  • Organization preparation
  • Gap analysis
  • Project Plan
  • Training
  • Documentation
  • Use and improve QMS
  • Internal Audits
  • ISO certification

Those are all the steps that will take your organization many steps ahead. So, what do you need to do if you want your organization to be certified? It is easy now. Follow the above steps up to the last one. ISO Pros only come in to help you in the last step, that is, ISO certification.

ISO 123485 Implementation and Certification Process by ISO Pros

Different service providers may have different approaches when it comes to helping an organization get certified. We are the experts who you can rely on to have the best of the services that you need. If you have completed the other steps listed above successfully, then you can turn to us to get certified.

We only become handy when it reaches the certification stage. We expect you to contact us for auditing against the ISO 123485 requirements and issue a certificate for compliance. Apply for certification by contacting us or filling out our online form. From there, you can readily schedule a date for auditing that we will honor. The auditing and certification are done by our professional auditors with experience in ISO 123485. This means that you will get the best for your organization. If it does not pass, then you will be tasked with the process of rectifying all the non-conformities and apply for certification after 3 months.

Benefits of working with us

You gain a lot of benefits to choosing our services. The first one is the cost-effective nature of the services that we offer. Our services are affordable to all and are of high-quality. Just contact us to inquire more.