What is ISO 13485?

What is ISO 13485 – Overview

The Medical Industry is booming with technological innovations. Some manufacturers produce the most advanced medical devices and equipment to treat patients with different problems. ISO 13485 is a QMS Regulatory Standard for the most common medical devices.

In this article, brief information about this ISO standard for the medical devices industry is provided.

ISO 13485

ISO 13485:2016 is a quality management system standard for medical devices that ensures compliance with regulatory requirements. It was last reviewed and confirmed in 2020.

Organizations or manufacturers engaged in medical device supply must follow this standard. The standard covers multiple organizational stages, such as manufacturing, maintenance, quality, distribution, servicing, installation, etc.

The standard applies to the design and development processes within the organization that manufactures new medical devices and equipment. Manufacturers are also bound to provide technical support to the customers who buy medical devices.

This standard applies to all organizations and companies in medical device manufacturing or supply. It holds manufacturers accountable for the safety and efficacy of their medical devices.

What are the requirements of ISO 13485?

The requirement of ISO 13485: 2016 applies to all types of organizations, including small and large enterprises working in the medical device industry.

An organization needs a quality management system to monitor, maintain, and control the production of medical devices and ensure users’ safety.

The entire structure of the ISO 13485 standard is split into eight different sections. The following list explains the basic criteria that every organization should follow under ISO 13485.

Quality Management System

This section requires documentation and adherence to Quality Management System requirements to ensure product quality and compliance with regulatory standards. The quality and control documents of the devices, including all the records to maintain quality, are required.

Resource Management

The Resource Management section covers the entire manufacturing department, including the environment and use of various resources.

Management Responsibility

Management responsibility requires regular maintenance and upgrading. The organization must mention everything in the final documentation.

Realization of Products

This section includes various departments of an organization where planning, distribution, quality maintenance, documentation, purchasing, designing, product review, installation, servicing, etc. are checked.

Analysis and Improvements

This section checks the lifecycle of the products, including the number of sales. Product analysis is crucial to boosting the business, so ISO 13485 includes product analysis and improvements.

The Current Version of ISO 13485

The current version of ISO 13485 is ISO 13485:2016, which has not been updated or revised with additional sections since its release.

Unlike ISO 9001, ISO 13485 focuses on the QMS of medical devices and equipment.

Is ISO 13485 Mandatory?

No. You have to maintain the quality and services of the products that your company is manufacturing. The QMS needs to meet the regulatory and legal requirements.

However, you must acquire the ISO 13485 standard to boost your business in the open market. This ensures that your products follow world-class standards and are of high quality.

This standard is mandatory for your business’s productivity, as it invites more customers, ultimately boosting production.

Frequently Asked Questions:

Question 1: Which regions is ISO 13485 applicable?

The European Union members require ISO 13485 for medical devices. Regarding regions, Australia, Canada, and many other regions follow this standard. The European Union has 27 member countries requiring compliance with ISO 13485 for medical devices.

Question 2: Is ISO 13485 different from ISO 9001?

ISO 13485 is based on ISO 9001. It is a stand-alone standard that adds more requirements for organizations manufacturing medical devices and equipment.

ISO 9001 is an internationally recognized standard, whereas ISO 13485 applies only to some regions.

An ISO 13485 standard requires additional documentation for medical device files, contamination control, a better environment for the workers, cleanliness of the products, sterilization of the products, and regular reporting to authorities about the production and the entire lifecycle.

Question 3: How many sections are there in ISO 13485?

ISO 13485 is structured into eight clauses, focusing on various aspects of quality management systems.

Question 4: In which year was the ISO 13485 standard last updated?

The ISO 13485 standard was last reviewed in 2020. It was established in 2016, ISO 13485: 2016.

Question 5: What changes have recently been made to the ISO 13485 standard?

The control of product supply and outsourcing, validation of software, proper training, monitoring, testing, and tracing, and management of corrective and preventative actions are just some of the things that the authority has recently changed or added to the ISO 13485 standard.

Final Thoughts:

The latest version of the ISO 13485 standard can affect your company.

You can learn more about the impact or, say, the benefits and advantages of following the ISO 13485 standard for producing medical devices and equipment from various sources available on the web.

The above article contains the information that every common man should know about the ISO 13485 standard for an organization’s QMS.

The ISO 13485 was last reviewed in 2020, so the version remains as it is! The authority has recently made some changes to the existing standard.

See Also

Medical Innovation Grant Opportunities

How to Register for NRMP

List of Medical Supply Companies

Current Version
July 10, 2021
Written By
Shubham Grover
April 18, 2024
Updated By
Andrea Morales G.

Follow us