What is ISO 13485?

What is ISO 13485? – Overview

Medical Industry is booming with the innovations in the technology world. Some manufacturers produce the most advanced medical devices and equipment to treat patients suffering from different problems. An 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

An ISO 13485: 2016 is a QMS Regulatory Standard for quality management of medical devices to meet the basic requirements of the customers. The standard was last reviewed in the previous year.

Organizations or manufacturers who are engaged with medical devices supply and manufacturers must follow this standard. The standard covers multiple stages of the organizations such as manufacturing, maintenance, quality, distribution, servicing, installation, etc.

The same standard acquired designing and development department of the organization where new medical devices and equipment are manufactured. Manufacturers are bound to provide technical supports also to the customers who bought the medical devices from them.

This standard applies to all types of organizations and companies working in medical device manufacturing or supply. The same standard makes the manufacturer responsible for the safety and uses of the medical devices they produce.

What are the requirements of ISO 13485?

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

It is for the Quality Management System where an organization needs to monitor, maintain and control the production of medical devices concerning the safety of the users.

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 the basic documentation and the Quality Management System Requirements to match the requirements of the customers. Quality and control documents of the devices including all the records to maintain the quality are required.

Resource Management

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

Management Responsibility

Management responsibility requires regular maintenance and up-gradation. Everything needs to be mentioned in the final documentation by the organization.

Realization of Products

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

Analysis and Improvements

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

The Current Version of ISO 13485

The current ISO 13485 is ISO 13485:2016. The standard was reviewed last year and added some sections to improve the quality of the medical devices including all the services and maintenance associated with them.

ISO 9001: 2015 was the only International Standard for the QMS until ISO 13485: 2016 was announced in the year 2016. 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, to boost your business in the open market, you need to acquire the ISO 13485 standard. This ensures your products follow the world-class standard and hence their quality is great.

This standard is mandatory for the productivity of your business as it invites more and more customers which ultimately boosts production.

Frequently Asked Questions:

Question 1: An ISO 13485 is applicable in which regions?

An ISO 13485 is required by the European Union members. If we talk about the regions, Australia, Canada, and many other regions follow this standard. There are over 161 members in the European Union members follow this standard for manufacturing medical devices and equipment.

Question 2: Is ISO 13485 is different from ISO 9001?

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

The ISO 9001 is an Internationally recognized standard; whereas the ISO 13485 applies to some regions only.

An ISO 13485 standard requires additional documentation for medical device files, contamination control, 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?

An ISO 13485 Standard has eight different sections for the quality control management and maintenance and servicing of the products.

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

An ISO 13485 standard was last reviewed in the year 2020. It was established in the year 2016 i.e. ISO 13485: 2016.

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

The control of product supply and outsourcing, validation of software, proper training, monitoring, testing, and tracing, management of corrective and preventative actions. These many things have been changed or added by the authority recently 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 the production of medical devices and equipment from various sources available on the web.

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

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

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Current Version
July 10, 2021
Written By
Shubham Grover

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