A Foolproof Guide to ISO 13485

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.

ISO 13485 destacado

What is ISO 13485?

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. This ISO standard can also be used with ISO 14971


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).

What is the Difference Between ISO 9001 and ISO 13485?

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.

What are the Requirements for ISO 13485?

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:

  1. Scope – Outlines the purpose of the standard, who can use it, and additional guidelines for the other clauses
  2. Normative References – Discusses introductory details and how ISO 9001:2015 is referenced in the standard
  3. Terms and Definitions – Defines the terminology used throughout the standard
  4. Quality Management System – Specifies the general requirements of the organization’s QMS for manufacturing medical devices, including:
    • Adhering to the standard
    • Implementing and controlling recordkeeping and documentation processes
    • Providing a standard quality manual to define all policies and guidelines
    • Maintaining medical device files that detail the general descriptions, purposes, and other vital labels
  5. Management Responsibility – Describes the involvement of the management to ensure successful implementation of the standard
  6. Resource Management – Ensures that resources such as personnel, infrastructure, and equipment are adequate and available to carry out the processes
  7. Product Realization – Deals with the overall medical device product journey from the conceptualization to implementation and how each stage must follow quality protocols
  8. Measurement, Analysis, and Improvement – Incorporates customer feedback via processes of data analysis, complaint handling, event reporting to authorities, continuous improvement, and regular product evaluation

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Certification and Training

What is ISO 13485 certification?

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:

  1. Create, implement, and maintain a QMS plan.
  2. Prepare documents, records, and other details that define your current processes aligned with the standard.
  3. Conduct internal audits to ensure that your organization abides by the regulatory requirements and standard guidelines.
  4. Establish management processes such as proactive risk analysis, hazard identification, Corrective and Preventive Actions (CAPA), and management review.
  5. Prepare for at least 2 stages of certification audit to be conducted by a third party.

Furthermore, some of the major benefits of being ISO 13485 certified include the following:

  • Streamlined cycles – With quality and customer satisfaction being at the core of operations, constant inspections and redesigns of products, services, and systems are conducted to help continuously improve production times in the supply chain.
  • Reduced waste – Complying with the standard allows organizations to establish a QMS that constantly monitors overproduction, excess inventory, and defects in the production cycle. This may lead to lower production costs and higher profits for the organization.
  • Wider market access – There are states and countries that prefer or require manufacturers at a certain level to demonstrate compliance by having a third party responsible for the auditing and certification.
  • Improved customer satisfaction – As quality is maintained in the manufacturing and distribution of medical devices, their impact on people’s lives can be converted into better customer experiences.
  • Established reputation – Organizations complying with ISO requirements can better market their products and services. Having met a standard of excellence, companies gain a competitive advantage by striving for and earning industry-recognized certification.

ISO 13485 training

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.

Patricia Guevara
Article by
Patricia Guevara
SafetyCulture Content Specialist
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.