ISO-13485-certified torrance ca

Getting ISO 13485 Certified in Torrance, California (CA)

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What is 65+85?

Is your business part of the industry involved in the designing, creating, manufacturing, assembling, or sourcing of medical devices? If you are, then securing an ISO 13485 for your company is what you need!

In case you’re not sure what ISO 13485, don’t worry, we’ll help you from A to Z!

ISO-13485-certified torrance ca

Simple Explanation of What ISO 13485 Is

To help you understand what ISO 13485 is in the best, the easiest, and the simplest manner, it is the international standard, widely used and accepted globally that pertains to the QMS or the quality management system as regards businesses and companies in the medical devices industry.

The simple purpose of the ISO 13485 standard is to be able to give assistance to businesses and companies in the industry and to allow them to provide proof and evidence that their business is of high quality. In addition to that, it’s a standard that’s based out on ISO 9001; it’s a standard drawn upon ISO 9001, due to quality requirements.  

What Being ISO 13485 Means

Should you be successful in implementing ISO 13485 all throughout your organization, and if you were able to become certified in the respective standard, then you basically have met all the requirements in being a medical device industry organization or company that produces quality products and provides quality services.

It means that your company has been approved and has been accepted to have quality management, leading to quality services and products.

Requirements of ISO 13485

Here are some of the additional requirements of the ISO 13485 standard for medical devices in some companies and organizations.

  • Requirements for the production of sterile medical devices
  • Requirements for the overall cleanliness of products and devices
  • Work environment needs
  • Control of contamination requirements
  • Reporting to regulatory and authorized group requirements
  • Documentation requirements for medical device files

NOTE: As you can see above, these are “additional” requirements of the ISO 13485 standard. There are a lot more and you’ll be able to find and figure that out when you get to training!

Where You Can Get ISO 13485 Certification

Are you here in Torrance, California and you’re looking for the best certification company that you can partner up with? Do you want to get ISO 13485 training and assistance without costing a fortune?

If you are, don’t hesitate to give us a call here at The ISO Pros and we will be more than glad to help you. We might not be experts in the medical devices industry, but we’re adept in the standard itself! Whatever specific part of the medical devices industry your company is in, you can bank and count on us to help you with everything you need in the ISO 13485 standard!

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In the event that you fall short of what your expectations are, you can send us a message and we’ll provide a free estimate to you!

Work with us and get the best ISO 13485 certification in Torrance, CA!

IQC The ISO Pros can help you implement, train on, consult, and have your company and/or organization certified on the following ISO Certifications: