Getting ISO 13485 Certified in Salt Lake City, Utah (UT)
ISO 13485 is for medical device companies. It is used for creating a quality management system that is effective in regulating how medical devices are designed, manufactured, installed, and serviced. Many medical device companies around the world are already using the ISO 13485 quality management system to meet the customers’ quality expectations.
How to become ISO 13485 certified?
This international standard has requirements for setting up a quality management system for medical devices. It is for many different organizations that are operating as medical device manufacturers or are part of the pharmaceutical supply chain. It is very essential for all companies that manufacture medical devices or offer such services that are needed in the medical devices manufacturing. Organizations that can implement ISO 13485 and become certified for it are as described below:
- Medical devices manufacturers
- Businesses that are involved in the supply of products, components, or raw materials needed for the manufacture of medical devices.
- Organizations that are involved in auditing medical devices for quality
- Companies that offer services to medical devices manufacturers.
Certification for ISO 13485 follows a successful implementation of a quality management system that follows the requirement of ISO 13485. Certification, in itself, is not a difficult project as you only apply for it with an accredited third-party to do it. If everything went well during the implementation, then your company will definitely pass the esterification auditing and a certificate of compliance will be issued to you.
How to implement ISO 13485?
This is where most organizations get stuck as a lot of things are involved. To implement this international standard, you first need to understand it. You may need training on ISO 13485 to understand its clauses and how they apply to your organization before you can proceed with the application.
Since many companies face many different problems while implementing this standard that makes it very difficult to get certified, ISO Pros are here to help you through every step needed to implement it. Please note that you cannot get certified until you successfully implement ISO 13485 quality management system.
The following are the main steps that you need to follow to implement ISO 13485. And remember that we have professionals who can help you go through each one of them. Our ISO implementation services cover everything involved in the process regardless of the size of your organization or how your company is involved in medical device manufacturing.
- Step 1: Obtain the documents and study to understand it.
- Step 2: Conduct A Gap Analysis
- Step 3: Develop an Implementation Plan
- Step 4: Design the Documentation
- Step 5: Provide Training
- Step 6: Carry Out Your Plan
- Step 7: Perform Internal Audits and Reviews
- Step 8: Select A Certification Body
- Step 9: Complete the Third-Party Audit and Certification Process
- Step 10: Maintain Your Certification
Contact ISO Pros to get professionals who are experienced in handling ISO 13485 implementation. Our experts will take you through the above 10 steps in the implementation and certification for ISO 13485.