ISO13485 Quality management systems (QMS) Standards for Medical Devices

ISO 13485 is a standard that the ISO created to ensure medical devices are safe and effective. The ISO13485 has been around for a long time. Still, they recently changed their standards to ensure that companies that produce medical devices follow the appropriate guidelines. It is designed to offer protection for patients and healthcare professionals and provide assurance on the safety of products.

Why is an ISO13485 certification good for your organization

The ISO13485 has been developed to ensure that the device’s manufacturer, supplier, and user comply with specific quality management systems standards. The certification also ensures that there are no significant risks or hazards associated with the use of the product. As a result, it is the most sought-after accreditation in the medical industry.

Why is an ISO13485 certification good for your organization?

Here are top reasons why you need to implement ISO13485 certification:

  • Improve organization reputation- The goal of the ISO 13485 standard is to guide how to achieve continual improvement in product safety, reliability, and performance. Getting certified shows the clients your company prefers quality, and they have a system to prove it. The certification can be a powerful marketing tool that can attract domestic and international clients.
  • Client satisfaction- One way to do this is by identifying the different types of customers in your industry and designing products for them accordingly. Customers are less likely to purchase any product because their supplier is not certified.
  • Creating a culture of improvement- It was made to create a culture of continual improvement to facilitate the development, design, production, installation, and servicing of safe and effective devices that conform with international quality management system requirements. When a systematic process is created, less time is spent correcting mistakes, giving more time for productive activities.

Contamination control and maintaining the cleanliness of medical devices :

Most medical devices contact the human body during the surgical process; if these products are not certified, they may consist of physical debris or biological agents causing various infections. Therefore, sterilization and cleaning of medical devices are strictly mandated by ISO13485. Sterilization is a necessary process that ensures the cleanliness of medical devices. It removes all microorganisms, bacteria, and viruses from an area or item. Sterilization may be accomplished through chemical means (antiseptics) or physical processes (heat-based methods). The cleaning process refers to removal of physical impurities from the device.

ISO13485 has some requirements to maintain the cleanliness of medical devices. They are:

  1. List and categorize the devices that required cleaning or sterilization before use. However, maintaining cleanliness is the essential quality needed for most devices, but some devices do not require sterilization, i.e., non-sterile needs to be listed separately.
  2. List the process agents used to clean the devices and the agents/tools required for sterilization.

Steps to ISO13485 certification :

The ISO 13485 certification is an internationally recognized medical device quality management system standard. With the growing popularity of healthcare products, it has become more critical to have a high-quality ISO 13485 certified product. To achieve this prestigious certification you need to take the following steps :

Steps to ISO13485 certification

  • Planning the quality system- ISO13495 includes the requirement of quality planning. It would be best to document the quality plans to introduce the changes in the quality management system. You need to have an ISO consultant as a part of the quality plan. It is recommended to select one partner for multiple locations of your business specializing in a specific industry.
  • Meeting regulatory requirements- The FDA published a guidance document that offers U.S. medical device companies valuable tips for developing quality plans to comply with the 21 CFR 820 regulation.
  • Documentation- The following list of documents needs to be prepared before beginning the first audit stage.
  1. Quality manual
  2. Organization chart
  3. List of procedures
  4. Corrective and preventive action processes
  5. Internal audit schedule
  • Certification audit- For certification, industry-level professionals will conduct two stages of audits.
  1. Stage 1 audit consists of a 1-day audit that receives the findings at the end of the day. It is recommended to keep a gap of at least one month after stage 1 to make the required changes if there are any negative findings. Once you clear the first stage, your company will be ready for the stage 2 audit.
  2. Stage 2 audit will involve multiple auditors and multiple days. Any major issues detected will prevent the recommendation for certification by auditors. Once the auditor completes his review and recommends certification, he must review your corrective plans to the Stage 2 findings. After accepting all the corrective action plans, there will be a review of all the documents submitted to the certification agent. A final certificate will be issued within a month of accepting all corrective action plans.

Checklist for implementing ISO13485

Checklist for implementing ISO13485

  • Management support- You need to prepare an excellent presentation to convince the management outlining the advantages your company will enjoy after implementing ISO13485.
  • Gather requirements- Once your management has agreed to your proposal, it is necessary to fulfill all the requirements to satisfy your QMS (quality management system). Examples of such conditions are customer requirements, regulatory requirements, etc.
  • Define the scope- When you define your scope, you get an idea of what business areas require the ISO13485 implementation. Quality policy and quality manual are some of the best tools that will help you define your scope.
  • Process and procedures- You need to determine the company’s processes to maintain consistent quality and how these processes interact to ensure quality meets the requirements.
  • Training and awareness programs- The success of Quality management systems depends on the execution of employees of your organization. This happens when they understand how QMS works and what role they have to play. All personnel associated with ISO13485 need to be trained and keep updated on any amendments.
  • Conduct internal audit- After you have operated QMS for a short period, it is time to conduct an audit before getting certified.
  • Certification- Once the internal audit is done, a certification body needs to review your documentation to verify all ISO13485 requirements are met. Choosing the right certification body is crucial for your clients and organization to feel confident in your processes.