The ISO 13485 Certification: Why You Need it and How to Achieve it

 Product quality is a key priority which manufacturing businesses always strive to achieve. It certainly becomes an essential attribute if you’re in the medical device manufacturing industry. Even a minor defect or flaw in the products can become extremely fatal for patients or even healthcare professionals using them. As a medical device manufacturer, it is your responsibility to ensure that all your products are quality-oriented and will deliver superior performance. Though you might often face difficulty in understanding or identifying the key parameters of quality estimation of your products, following the guidelines as stated in the process of the ISO 13485 certification can be of great help for you. Want to find out how? Let’s dive deeper into what this certification/standard is all about.

 


The ISO 13485 standard: What is it


ISO 13485 is a quality management standard specifically designed to help the medical device manufacturing industry for delivering superior quality products. This standard is developed with a focus on ISO 9001 however, it comes with a series of additional requirements related to manufacturing, servicing, and installing different types of medical devices. It helps in:


• Establishing a Quality Management System (QMS)

• Validating processes

• Implementing efficient methods for ensuring product traceability

• Implementing a risk management strategy in sync to product development

• Adhering to statutory and regulatory requirements

• Initiating process and product improvements 

• Promoting operational efficiency


How to get your business ISO 13485 certified


The ISO 13485 standard is made up of a list of requirements which, need to be fulfilled by various types of companies operating in the industry of medical device manufacturing and pharmaceutical supply. Some of such types of organizations are:


• Medical device manufacturers, along with manufacturer of surgical and sterile medical devices

• Companies which offer components and raw materials to medical device manufacturers

• Quality management organizations working with manufacturers of medical devices

• Organizations which offer services to medical device manufacturers


Let’s go through the steps you will follow to get your business ISO 13485 certified.


Step 1: Get the necessary documents and analyze the requirements


After making the decision to get the ISO 13485 certification, it is important for you to know about the requirements. You should start by getting a copy of this standard and other supporting documents (if any). These will serve as a reference for you while developing the implementation plan, as well as for the auditor while assessing the QMS. 


Step 2: Gap analysis


Next, you must focus on conducting the gap analysis, or pre-audit, when your core objective will be to assess the existing processes of the company and check whether they meet the ISO 13485 requirements properly. This in turn, will help you in filling in the gaps in between the system you need to implement for achieving the certification and the current system of the organization. 


Step 3: Prepare the implementation plan


Next, comes the step of developing an implementation plan which must include quantifiable and well-defined objectives that must be achieved within specific deadlines. It will include framing your quality policy and manual, examining the existing processes, and changing them accordingly for the requirements set by the standard. The defining scope of the organization and all the tasks which need to be accomplished for adhering completely to the standard’s requirements, must be clearly stated in the implementation plan.

 

Step 4: Design the documentation


To control the processes, you will certainly require documentation as it will also help in proving your organization’s compliance and guide you through the processes. A certain level of flexibility is accepted in designing the documentation process however, you must ensure that it fulfils all the requirements of ISO 13485. 


Step 5: Offer comprehensive training and implement the QMS


The next step is offering the right training and support to all your employees for the ISO 13485 implementation. You need to ensure that all your employees are familiar with the process of this standard’s implementation to avoid any kind of discrepancy or confusion. This will ensure minimal disruption to regular job responsibilities of your employees. After all, they are now being trained in the transition your organization is striving to achieve. With the right training and support you will be able to move forward with implementing the QMS with adherence to the ISO 13485 requirements. 


Step 6: Conduct an internal audit


Before applying for any third-party audit, you should always conduct an internal audit and management review. These audit processes will help to find out how the newly or improvised QMS is working and whether it adheres to the standard. 


Step 7: Choose a certification body and complete third-party audit for final certification


You should research and select the most competent certification body by going through its relevant experience, qualifications, accreditations, and more. Selecting a reputed auditor will ensure that the certification process goes smoothly. After selecting the auditor, your third-party audit will start. If all the requirements are being met by your QMS, then your organization will be certified. However, if you fail to meet any of the requirements, then you need to work on changing your QMS accordingly and get it certified accordingly. 


The final thoughts


Your task doesn’t end after achieving the ISO 13485 certification as you need to ensure that the right procedures of maintaining it are being performed well. Hence, it goes without a saying that the process of achieving a certification can be extensive, tiresome, and time-consuming. It is always advised to hire a knowledgeable ISO consultant who will be able to take care of all your requirements and help you in the process of getting your business ISO certified.

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