Quality management is more important than anything in the medical device industry. There are strict regulations and specific manufacturing guidelines that companies must follow for ensuring the safety and quality of medical devices. Regardless of whether a company produces, assembles, distributes, repairs, services, or installs medical devices, it needs to prove its compliance with best manufacturing practices and regulations to make its products or devices safe and reliable to the customers. The ISO 13485 certification is given a prime importance by medical device manufacturers because of this reason. It is the most recognized and specialized certification for medical device businesses developed by ISO. A business achieving it would demonstrate that their devices are designed, manufactured, distributed, installed, or serviced to the highest regulations and so they are of legitimate quality.
The ISO 13485 standard provides a framework of practices for quality management adopting which ensures that the medical devices meet both client obligations as well as legal and regulatory requirements. If you want to achieve the certification for your medical device business, here are a few simple steps you need to take.
5 Steps to Get the ISO 13485 Certification for Your Medical Device Company
Decide the Scope of Your QMS
To achieve the ISO 13485 certification, you need to first outline the quality goals of your medical device business and frame the scope of your QMS (Quality Management System). It means you should focus on the type of your devices, its utility in medical treatment/diagnosis/any health services and what customers expect from it. If you get an ISO consultant, they can better help you understand the scope by evaluating your products and customer expectations.
Create the Necessary ISO 13485 Documentation
After the scope is established, you need to plan the structure of the QMS depending on your existing procedures. Next, you need to document all new practices or processes that are needed for implementing the QMS successfully and deriving the desired outcomes. Both existing quality processes and new processes under the QMS must be documented because that ensures uniformity and consistency in following those processes by the employees. The documentation thus elaborates how your medical device should operate from now to ensure quality compliance.
Employee Training
While documentation is a crucial step for making employees aware of the new quality processes, training is equally important to ensure they can put the processes into practice. The senior management team of your organization should undertake the responsibility of training your employees. By discussing with the consultants, they can curate tailored training sessions and learning resources for the employees. Providing timely training ensures that the implementation of QMS is thorough according to the ISO 13485 requirements and its processes are competent enough.
Submit to an Accreditation Body
The ISO 13485 certificate must be awarded to your business by a recognized accreditation body. Thus, you need to do some primary research and get a reliable third-party body for your certification. After you apply for the certification, they would perform an audit in two stages to ensure your business’s conformance to the ISO 13485 requirements. The consultants can prepare your business for this stage by performing an internal audit, where they ensure that your processes are already conforming to the standard.
Certification Awarded
When the third-party accreditation body confirms your business’s compliance with the ISO 13485 requirements, they would grant you the certification. The certification has a validity of 3 years after which you need to apply for recertification.
Key Takeaway
For any medical device business, the ISO 13485 certification is essential to stand out in the competitive industry by demonstrating its compliance with best quality practices and regulations. This makes customers believe or trust their products which helps them to attain growth besides improving the reputation in the industry. The certification is a mark of excellence for quality for the medical device industry and so you should not be delaying any further to achieve it!
