This ensures the consistent quality of the equipment medical professionals and patients are relying on all over the world.Īnother key difference between ISO 9001 and ISO 13485 is in the documentation and regulatory requirements. 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. 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. However, there are a few key differences between the two sets of standards that are important to note.įirstly, the ISO 9001 standards are internationally recognized and apply to companies across the entire marketplace. ISO 13485 may seem redundant to publish after researching ISO 9001. 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 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. This is the detailed documentation process of the exact inner-workings of the new medical device. Then, the next step in achieving or obtaining an ISO 13485 certification is the implementation of design controls. 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.īy 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. Therefore, their value to your organization in pursuit of any ISO certification is undeniable.Īfter the quality planning phase for ISO 13485, firms need to address the industry regulations. ISO consultants are more readied with the appropriate knowledge and information pertinent to various ISO standards, and the ISO regulations in general. In addition to the planning materials, the organization should also include an ISO consultant in their quality-planning. Many teams use gantt charts and excel documents to map out and document their quality planning. 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. In the planning phase for ISO 13485, specific documentation is required.įirstly, the organization in pursuit of ISO 13485 must include quality planning materials. Then, depending on which ISO certification the organization is pursuing, that planning phase may look slightly different, or address varying organizational elements. The ISO certification process is almost always going to begin with a planning phase. 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. However, with the help of Glacier Consulting, your path to ISO 13485 certification will be much more clear. It does not store any personal data.Obtaining any ISO certification is an undertaking. The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. The cookie is used to store the user consent for the cookies in the category "Performance". This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other. The cookies is used to store the user consent for the cookies in the category "Necessary". The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". The cookie is used to store the user consent for the cookies in the category "Analytics". These cookies ensure basic functionalities and security features of the website, anonymously. Necessary cookies are absolutely essential for the website to function properly.
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