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What is ISO 13485?

One of the most widely used international standards developed to control the quality of medical devices is ISO 13485 and it provides a framework for process-based quality management procedures.

Xomety X
By Team Xometry
October 14, 2021
 5 min read
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The medical device manufacturing industry is highly regulated. This is primarily due to the potential for loss of life or serious injury related to poor-quality medical devices. One of the most widely used international standards developed to control the quality of medical devices is ISO 13485. This standard is used to implement and maintain an effective quality management system (QMS) within the medical device manufacturing industry. 

ISO 13485 does not directly define the individual quality requirements for specific medical devices or for classes of devices. Rather, it provides a framework for process-based quality management procedures. The required final product quality should be achieved if the quality management processes and procedures defined within the standard are followed and accurately implemented within an organization. This article will explain what ISO 13485 is, how to implement it, and what benefits it can offer to a medical device manufacturing organization.

Who needs to be certified?

ISO 13485 has become one of the most widely used QMS standards in the medical device manufacturing industry and is mandatory in some countries. It forms the basis for quality management system requirements in Japan, Canada, the European Union, and various other medical device markets. In the United States, the FDA is planning to harmonize its own medical device QMS standards with the ISO standard. This will make ISO 13485 a true international standard. Organizations that manufacture medical devices must often be certified in accordance with a recognized QMS standard in order to meet local or national safety regulations. To compete on the international stage it may be more beneficial to certify in accordance with a well-recognized standard like ISO 13485.

How to become ISO 13485 certified?

To become certified a company needs to prove that its procedures already conform to the requirements set out in the standard. Therefore, a company needs to implement all the quality management systems and operate the company within the framework of the standard. This is not intended to be a pure paperwork exercise but rather the demonstration of a fully functional system that permeates the entire company’s culture with the purpose of standardizing the quality management system. The basic steps for bringing an organization into compliance with ISO 13485 requirements are listed below:

  1. Understand the standard. Before embarking on the process of making a company compliant, it is important to develop a thorough understanding of the standard and its requirements. This will help in developing an implementation plan as well as giving an idea of the financial and time commitments for implementation. 
  2. Perform a gap analysis. A gap analysis must be performed to determine what changes are required to the company's existing QMS. A gap analysis can be performed by an experienced Internal Auditor or a member of the quality department using a checklist or by engaging an external consultant. 
  3. Plan the implementation of the system. As with any large project, a project plan is essential to identify the key stakeholders, milestones, and budgetary requirements for the effective implementation of ISO standards and subsequent certification.
  4. Train organization on the requirements. For successful implementation of ISO 13485, the entire organization must be properly trained on how to work efficiently within the constraints of the new system and how to achieve the goals listed in the standard.
  5. Document the QMS. A large part of the ISO 13485 requirement is the documentation of relevant processes and procedures that need to be followed to achieve compliance. These need to be thoroughly documented.
  6. Implement the QMS.  Once the QMS has been developed, it needs to be implemented throughout the organization and actively used by everyone in the company.
  7. Perform an internal audit. Internal audits are required to monitor the performance of the QMS within the organization. These audits will help to detect any issues not originally identified in the planning phase and can aid in preparations for the formal audit. 
  8. Request for a registration audit. The final step in the certification process is to invite an official ISO 13485 auditor to review the company's QMS procedures. The auditor will determine whether the QMS meets the latest edition of the ISO 13485 standards and whether the QMS is in active use throughout the organization. If the auditor is satisfied that the company conforms to the latest version of the requirements of the standard, then an ISO 13485 certification is issued to the company. This certificate is only valid for a 3-year period whereupon another audit must be performed. It is important that a company remains compliant with the latest version of the standard throughout this 3-year period to ensure a successful audit at the end of the 3-year period.

How an ISO 13485 certification can benefit your company?

ISO 13485 certification can bring a wide range of benefits to accompany, some of which are listed below:

  1. Satisfy customer requirements. ISO 13485 stresses the importance of taking the customers’ needs into account. This reassures the customer that the company, which is ISO 13485 certified, places customer satisfaction above internal departmental goals.
  2. Gain a competitive advantage. When competing on the international stage it is important to leverage internationally recognized certification bodies to prove that a company's products are, in fact, world-class. ISO certifications are recognized all over the world and imply a certain level of excellence. 
  3. Improve internal operations. ISO 13485 is not a static, unchanging system. Data collected from regular audits inform the next revision of the standard. This ensures that improvements are properly planned and only implemented to further increase performance, profitability, and more efficient operations within a company. 

Due to the highly regulated nature of the medical device industry, it is absolutely critical that a company hoping to market its medical devices to a wide audience be compliant with a QMS specifically tailored to this industry. The growing acceptance of ISO 13485 and its expected adoption by the FDA, make it clear that ISO-13485 certification will benefit any medical device manufacturing company.

Xomety X
Team Xometry
This article was written by various Xometry contributors. Xometry is a leading resource on manufacturing with CNC machining, sheet metal fabrication, 3D printing, injection molding, urethane casting, and more.