A Complete ISO 13485 Implementation Checklist For Fast Certification

Have you been thinking about implementing a quality management system for your medical devices? Are you keen on obtaining the ISO 13485 certification to improve product quality? Then this blog is for you!


The advancement of technology in the medical device manufacturing industry comes with much potential for pitfalls. Even the tiniest mistake in your medical devices can lead to the mistreatment of a patient. Hence, having a quality management system is not an option anymore but a necessity.


However, getting started with a QMS can be challenging. With all the regulations and framework, you may wonder where you should even start!


That’s why we have created a step-by-step checklist to implement a medical device QMS according to ISO 13485.


So, let’s get started!


An ISO 13485 Implementation Checklist For Fast Certification


Before starting the execution process, it’s essential to thoroughly grasp the requirements of ISO 13485 and ensure your existing QMS matches them.


Once you’ve confirmed that, follow these steps for the implementation.


1. Management Support


Without the support of your top management, you can never make your management system a success. Therefore, ensure you have the support of all your department leaders and managers. You can consider making a presentation outlining the perks of ISO 13485 to get the team on board.


2. Identify Requirements


The next step you need to fulfil for ISO 13485 certification is making sure that your QMS satisfies all the standard’s clauses as well as legal and customer requirements. Also, you should consider the requirements of your company and culture.


3. Define The Scope


When defining your QMS scope, you must first identify what processes will be affected by the system, what changes you have to make, and the implementation boundaries. You can refer to your quality policy and quality manual to help define the scope of the system.


4. Describe The Processes And Procedures


There are a few mandatory procedures in ISO 13485 that must be a part of your QMS. Besides those, you may determine what other processes your company needs to ensure consistent quality. Next, you will define those processes and demonstrate how they interact.


5. Implement Procedures And Processes


While documenting every process is unnecessary, some procedures should have a record. Recognize them and ensure you document them during execution.


6. Training And Awareness Programs


Every employee of your organization should have sufficient knowledge about the QMS and their contribution to it. The best way to ensure this is by providing training and deploying awareness programs in the organization.


7. Choose A Certification Body


Once you have implemented the medical device quality management system, consider hiring an accredited certification body. They will be the ultimate auditors to determine whether the system complies with the standard. Furthermore, they will test the system's effectiveness, ask about continual improvement  as part of their certification program.


8. Measure The QMS


After hiring the certification body, you need to start organizing the records required in the audit process. These records will act as evidence indicating the maturity of the system.


9. Internal Audit


You will get a good idea about your QMS after using it for a while. However, before the certification audit occurs, it’s wise to perform your internal audit (which is also a requirement of ISO 13485). The internal audit will allow you to identify shortcomings and perform corrective actions.


10. Management Review


Management reviews typically focus on examining information related to QMS activities to ensure its effectiveness. Managers also use this opportunity to determine whether they have all the resources to maintain and improve the system.


11. Corrective Actions


If you identify any nonconformity during the internal audits and reviews, here’s your chance to correct them. Performing corrective actions also indicates continuous improvement.


12. Certification Audit


This is where your hired accredited certification body will review the system and documentation and issue the certification. Take sufficient time to plan the final audit and resources to avoid a bumps in the road.


Summing Up


So, are you ready to achieve your ISO 13485 certification? Hopefully, this guide will help you create a well-thought-out plan for the journey ahead. Ensure you have all the time and resources to sufficiently develop a QMS and ultimately certification.

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