International Organization for Standardization defines ISO 13485 for companies involved in the design, production, installation, and servicing of medical devices and related services. This standard specifies requirements for a quality management system (QMS). ISO 13485 can also be used by internal and external parties, such as certification bodies, to help with auditing processes. ISO 13485 compliance occurs when impacted organizations can demonstrate that their QMS follows regulatory best practices throughout a product’s lifecycle from creation through service and delivery of medical devices that are safe and effective for their intended purpose. ISO 13485:2016 was published in March of 2016 and is the latest version of ISO 13485 as of March 25, 2021.
Although ISO 13485 is heavily based on the ISO 9001 standard for quality management systems, there are some key differences.
By aligning their quality management system with ISO 13485, medical device manufacturers reduce the risk of product nonconformities and ensure patient safety. Additional benefits include:
ISO 13485 outlines the requirements for designing, developing, and maintaining a medical device throughout its entire lifecycle. This includes the implementation of a quality management system and processes centered around documentation and risk management.
ISO 13485 compliance is demonstrated when organizations can demonstrate that their quality management system (QMS) follows regulatory best practices throughout a product’s lifecycle from creation through service and delivery. The International Organization for Standardization (ISO) is a non-governmental organization that creates and publishes international standards to support innovation, quality, and challenges across the globe.
Maintaining all the documentation necessary for ISO 13485 compliance can be time-consuming and prone to errors if you use paper, spreadsheets, and other manual, disconnected systems. It is difficult to identify the latest revisions when files are stored in multiple locations. And you don’t have full visibility into product nonconformities and other quality issues which create audit risks.
By leveraging electronic quality management system (eQMS) software, companies can take advantage of a paperless approach to quality management with more control over documentation and processes needed to prove compliance. With a product-centric eQMS, all team members can access the latest product and quality records from a centralized location and efficiently execute their product development activities. Through automated change processes and revision controls, you can be confident that information is always accurate and up to date. This gives way to better visibility and traceability throughout the product lifecycle. In addition, you can effectively manage training records, supplier information, CAPA processes, and other critical documentation that is addressed in the ISO 13485 standard.
Although ISO 13485 certification is voluntary, many countries such as the European Union (EU) base their regulatory standards for medical devices on ISO 13485. Thus, it is beneficial to earn certification if you plan to market and sell your products in those regions.
To obtain your ISO 13485 certification, follow these steps:
If any significant nonconformances are revealed during the audit, your organization will need to implement the necessary corrective actions and have them verified by the auditor prior to receiving a certification.
Upon passing the audit, you will be issued an ISO 13485 certification that is valid for three years.
ISO 13485 is intended to help medical device companies consistently produce safe and effective products. It also provides guidelines for risk management to help organizations avoid product recalls.
*Source: https://advisera.com
Any company involved in the design, development, manufacture, and/or distribution of medical devices can obtain ISO 13485 certification.
*Source: https://13485store.com
Technically, ISO 13485 is not a legal requirement. You can create a QMS that suits your needs for your organization, so long as the processes of the QMS meet the legal and regulatory requirements for medical devices where you intend to manufacture and sell them. Even though ISO 13485 is not required for EU MDR compliance, the EU MDR regulation requires that you have a QMS in place, and the ISO 13485:2016 standard is the only QMS standard listed in the EU list of harmonized standards, so most companies will use the ISO 13485 requirements to implement their QMS.
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ISO 13485 certification denotes that a company has established an ISO 13485 quality management system and has met all the standard’s requirements. ISO 13485 assesses if your quality management system is acceptable and effective, with a focus on medical device safety and efficacy.
*Source: https://13485store.com
Having an effective quality management system (QMS) is important both for ISO 13485 compliance and for ensuring commercialization success. Read our article to learn the key elements to look for in a QMS system.