ISO 13485 Standards for Medical Devices Quality Management

The standard for the Quality Management System is referred for the design and manufacture of Medical Devices is known as ISO 13485. Whereas ISO 13485:2016 is an individual document and aligns with ISO 9001:2008 because it does not follow the structure of the latest version of 9001. The rules and regulations are depending upon the countries as countries have their own set of regulations. 

What is ISO Certification?

There are two types of certifications. 

1. Certification of Quality Management System of the company against the requirement of ISO certification. 

2. Certification of the individual is required to audit. 

Certification for your company requires implementing the QMS and then hires the recognized certified body to audit and approve the standards. When all the procedures are in place then you need to operate QMS for some time, by doing this you will get the necessary records to process further to audit, review, and certification.  

Let us first understand what is the purpose of ISO 13485?

Purpose

The medical device industry widely used international standards for quality management. This is issued by the ISO i.e. International Organization for Standardization. It is the standard of an effective solution to meet the requirement for the medical device industry. It also provides a practical foundation for manufacturers as well as demonstrating the commitment for the safety and quality of medical devices of EU Medical Device Directive (MDD), and EU Medical Device Regulation (MDR).  

The current version of ISO 13485

ISO latest revised on March 2016. In this latest version, they included many things. They are: 

1. A more focus on risk

2. Amplification of management responsibilities

3. Amplification of training responsibilities

4. Improvement at facility requirement

5. Design and development requirements for many regulations.

6. Improvement on control suppliers

7. Traceability procedures

8. Improvement at Complaint handling process

9. Enhancement of product cleanliness requirement

These are the improvement that the current version of ISO 13485 Certification has. These are the requirement which is acceptable on the basis of implementing a QMS.

Is ISO 13485 mandatory? 

This is the common question that every organization will face it and they even wonder to take ISO certification or not. The simple answer is NO, ISO 13485 is not mandatory. With respect to ISO, you can create QMS which best suits the needs of your organization. As long as the QMS process meets the legal and regulatory requirements for medical devices, you can manufacture and sell the product.