This guide will walk you through the following: what the international standard ISO 13485 covers, its importance, how it differs from ISO 9001, and the specific requirements.
Published 6 May 2022
ISO 13485 is an international standard created by the International Organization for Standardization (ISO) for organizations that design, produce, install, and distribute medical devices and other related services. Applicable to organizations of all sizes and types, ISO 13485 details requirements on how to establish a Quality Management System (QMS) for an organization to provide medical devices that comply with relevant regulations as well as customer requirements. With this, the standard is commonly called a medical device quality management system.
In most cases, ISO 13485 standards are used by internal and third-party organizations such as certification bodies for their inspection and auditing processes. They are responsible for helping companies in the medical devices industry to monitor their compliance and the quality of their manufacturing operations.
Since safety and quality are of utmost importance in the medical device manufacturing industry, the sector is highly regulated. Regulations are enforced for organizations to meet satisfactory standards and comply with legal requirements and ensure that the medical devices they distribute in the market are proven safe for consumers and serve their purposes. Establishing an international standard such as ISO 13485 helps lay down detailed guidelines for creating and maintaining a QMS.
Is ISO 13485 mandatory for medical devices?
ISO 13485 is not mandatory for medical devices. You can always create a QMS that fits the needs of your organization. Just ensure that your processes comply with the legal requirements for medical devices relevant to where you’re manufacturing and selling them.
On the other hand, it’s highly encouraged that organizations have a QMS in place that follows internationally-recognized standards and ensures quality in manufacturing medical devices for consumer safety and trust. For example, Financial Express cites that the ISO 13485 standard helps manufacturers be at par with global standards and the international market.
With recent innovations such as how 3D printing fills gaps in medical device manufacturing, the ISO 13485 standard and its certification process help regulate the production and commercialization of such products before market distribution. This coincides with the bigger picture of following Good Manufacturing Practices (GMP), which are set out under the authority of the Federal Food, Drug, and Cosmetic Act by the US Food and Drug Administration (FDA).
ISO 13485 is essentially a separate version of ISO 9001. While ISO 9001 outlines the general guidelines for a QMS, ISO 13485 gives instructions on how to establish a QMS that complies with regulations and standards which are relevant to the medical device manufacturing industry. Another key difference is that ISO 13485 uses the process-based approach from an older iteration of ISO 9001—ISO 9000:2008. This approach, in particular, centers on the Plan, Do, Check, Act (PDCA) methodology.
To keep up with the changing times, reviewing QMS standards is essential to check if there are things that need to be revised, omitted, or improved. With its current version known as the ISO 13485:2016, market updates, technological changes, revisions in regulations are taken into account. According to the ISO, major changes include “greater emphasis on risk management and risk-based decision making” as well as “increased regulatory requirements for organizations in the supply chain.”
The ISO 13485 overview is comprised of the following clauses:
Though the standards are released by the ISO, separate enforcement agencies are responsible for the implementation and monitoring of organizational compliance. These third parties, who must be members of the International Accreditation Forum (IAF), audit the performance of the QMS and how it aligns with the current ISO 13485 requirements. A certification is typically valid for a 3-year period, so recertification is needed to maintain an organization’s status.
It’s also important to remember that like with any other ISO standard, certification isn’t required, but it can help you better demonstrate to regulators, clients, and other stakeholders that you are ISO 13485 compliant as well as consistently meeting customer and legal requirements.
As an overview, here are the basic steps on how to get ISO 13485 certification:
Furthermore, some of the major benefits of being ISO 13485 certified include the following:
To establish a culture of quality and safety in your organization, providing ample and relevant training programs for compliance practices is highly recommended. Encourage your leaders, managers, and workers to consistently maintain the quality of your processes in manufacturing medical devices with consumer safety and legal duty in mind.
Having a streamlined process of maintaining quality in the workplace helps ensure that your organization won’t miss any vital information, requirement, or regulation. Using powerful mobile app solutions such as iAuditor by SafetyCulture is key to maintaining compliance with statutory regulations as well as ISO 13485 standards, and ensuring quality manufacturing of medical devices that customers need and trust.
With iAuditor, you can do the following:
To help you get started, here are some ISO 13485 checklist templates you can download and customize:
Patricia Guevara is a content writer and researcher for SafetyCulture. With her extensive content writing and copywriting experience, she creates high-quality content across a variety of relevant topics. She aims to promote workplace safety, operational excellence, and continuous improvement in her articles. She is passionate about communicating how technology can be used to streamline work processes, empowering companies to realize their business goals.
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