Quality Management System – For Medical Devices & Related Services

In some cases, the general rules or standards that would apply, simply aren’t enough. In these instances, a more advanced subset of conditions will emerge. A good example of this is the difference between the title “artwork” and the title “painting”. While this is a very broad generalization, the rules and subset rules are both very clear – one applies to any piece of art, and the other specifically applies to paintings. This was the case for the development of ISO 13485. 

ISO 13485 is another series of ISO standards that relate to quality management. However, the difference is that ISO 13485 is industry-specific. This is important because it highlights how various industries and companies within those industries may seek slightly different ISO certifications based on the applicable elements of those standards. 

As mentioned above, ISO 13485 is another set of standards published by the ISO relating to quality management. ISO 13485 specifically addresses the quality management of medical devices and equipment. 

The medical devices and equipment industry is one that has a very small margin of error. With lives literally at stake, a consistent quality in the production of medical devices is absolutely vital. As such, the industry felt that a more stringent and industry-specific set of standards was required to monitor and regulate the industry. 

Obtaining any ISO certification is an undertaking. However, with the help of Glacier Consulting, your path to ISO 13485 certification will be much more clear. However, if you need more help, don’t hesitate to visit Glacier Consulting’s home page, and get in touch with an expert ISO consultant ready to tackle any of your ISO needs. 

The ISO certification process is almost always going to begin with a planning phase. Then, depending on which ISO certification the organization is pursuing, that planning phase may look slightly different, or address varying organizational elements. In the planning phase for ISO 13485, specific documentation is required. 

Firstly, the organization in pursuit of ISO 13485 must include quality planning materials. These materials should extend beyond a quality-manual and move even further into tangible process plans that outline how the organization is going to improve the quality management system. Many teams use gantt charts and excel documents to map out and document their quality planning. 

In addition to the planning materials, the organization should also include an ISO consultant in their quality-planning. ISO consultants are more readied with the appropriate knowledge and information pertinent to various ISO standards, and the ISO regulations in general. Therefore, their value to your organization in pursuit of any ISO certification is undeniable. 

After the quality planning phase for ISO 13485, firms need to address the industry regulations. This is one of the core elements of ISO 13485, holding the manufacturers of medical equipment and devices accountable for the quality of the devices that they produce. 

By pushing manufacturers to meet device-regulations through the ISO standards, and as a requirement of certification, elevates the level of quality on all medical devices currently circulating the market. 

Then, the next step in achieving or obtaining an ISO 13485 certification is the implementation of design controls. This is the detailed documentation process of the exact inner-workings of the new medical device. The design controls show to the FDA the proper functionality and operations of new medical devices, and how they’ve been designed to be safe and efficient. 

Most medical device manufacturers already have a design-control documentation process implemented into their organization, so this may be redundant, but the process should still be reviewed at the point of ISO 13485 planning.

The next two steps in obtaining ISO 13485 certification relate to documentation, record keeping, training, and managerial processes. 

The first, relating to documentation and training, is a vital step in the actual certification process. Having a trained staff that’s aware of the new processes and procedures is critical to making it through the final phase of the certification process. 

Additionally, every single ISO standard that is published requires a buy-in from upper management. The reassurance and commitment to new operations from the executive and management teams in the organization will go a long way in cementing the new systems. 

The final step, as it is in any ISO certification process, is the external audit. This is when a 3rd party company reviews the work you’ve done in planning, the new systems set up in place, and the new documentation regulations. If the audit is passed, congratulations – your company is now ISO certified. 

ISO 13485 may seem redundant to publish after researching ISO 9001. However, there are a few key differences between the two sets of standards that are important to note.

Firstly, the ISO 9001 standards are internationally recognized and apply to companies across the entire marketplace. The ISO 9001 standards are there to help organizations ensure that they’re prioritizing the customer experience and delivering a consistent quality in both product and service. 

On the other hand ISO 13485 is specifically catered to medical device manufacturing and the regulations that medical devices and their producers need to meet. This ensures the consistent quality of the equipment medical professionals and patients are relying on all over the world. 

Another key difference between ISO 9001 and ISO 13485 is in the documentation and regulatory requirements. Within the ISO 13485 standards, these requirements are more stringent as data and regular checkups on the equipment are much more important when it comes to medical devices than it may be in other industries. 

Any manufacturer or producer of medical devices and medical equipment needs to ensure that they’re meeting the standards laid out in ISO 13485, and should go the extra mile and seek certification as well. 


Millions of people around the world are relying on medical equipment to function properly. ISO 13485 helps the producers of medical equipment meet high standards day-in and day-out to ensure that only the highest quality products make it onto the hospital floor. 

For more information on ISO 13485 visit Glacier Consulting’s home page, and get in touch with an expert ISO consultant today.