ISO 13485 – Purpose & Benefits


The International Organization for Standardization (ISO) is a not-for-profit and non-governmental organization with its central office in Geneva, Switzerland. It comprises standards institutes and helps form a bridge between public and private sectors, making it the most significant standards organization in the world.

ISO 13485 in detail:

ISO 13485 deals with specifications related to a quality management system that an organization capable of supplying medical devices and associated services needs to prove. These services should sync with the clients’ demands and applicable supervisory conditions. Such organizations can participate in different stages of manufacturing a medical device – from production, design, development, and distribution to storage, servicing, and providing help in related activities. 


When a manufacturer adopts ISO 13485, he acquires a platform to address The EU Medical Device Directive & Regulation and other regulations while show-casing commitment to provide for quality and safety of medical services. 

Beginning with management support and identifying the clients’ wants for quality management, a manufacturer can document a portfolio that can be constantly worked upon. This factor will provide an outline and objections to the Quality Management System. Besides this, a company should maintain the compulsory & extra procedures necessary to create and deliver the best product or service.

According to a survey, ISO 13485 certified companies which have implemented a Quality Management System are making positive progress worldwide.

All these requirements and conditions apply to all organizations despite their size or type. If any provision is specific to one category of medical devices, it equally applies to associated services supplied. 


Companies have witnessed how an efficient Quality Management System (QMS) naturally helps save cost, time, and other improvements.

A few of the main benefits are:

. Improvement of a company’s credibility:

Since this ISO is the gold standard for quality in the medical device production industry, certification to this standard is a huge deal. It is proof that a company takes quality standards seriously, but it also ensures clients about how reliable the system is. QMS can be a fantastic marketing tool not limited to one country.

. Satisfaction of the Customer:

The existence of quality management principles and certification means increased opportunity and revenue. Striving to assess and meet a client’s requirements will prove beneficial in the long run. 

. Constant Improvement:

With the help of the process approach outline, identifying and rectifying errors will improve processes and increase focus towards providing quality products and services and less time wasted on cleaning up mistakes. Besides growth, there will be a lesser wastage of raw materials involved in processes, thus increasing efficiency and reducing cost.

Decision-making with the aid of available evidence or data can help meet the company’s strategic goals.

. Products are subject to External Reviews:

With this certification comes regular check-ups and investigations to ensure the quality being delivered, which provides room for improvement and productivity.

. Employment:

Contributing to an ISO-certified company is a big deal. Learning techniques and processes to bring changes can increase the employment rate or prove an asset to an existing employee.

ISO contains standard institutes from 164 countries worldwide, each with its name – for example, Standards Australia is a member body that is the best standards organization in the nation. Being tested and proven, it provides standards internationally agreed as the ‘best’ by experts, making it one of the greatest and respectable organizations in existence.


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