ISO 9001 vs ISO 13485: Difference and Comparison

A management system is beneficial for both the manufacturer and consumer of the product. A manufacturer company can gain the trust of its potential customers while customers can obtain the assurance of the quality of products.

ISO 9001 and ISO 13485 are two types of such management systems that are facilitating people in almost every country.

Key Takeaways

1. ISO 9001 focuses on customer satisfaction and continuous improvement of processes, whereas ISO 13485 focuses on the safety and effectiveness of medical devices.
2. ISO 13485 requires additional documentation and emphasizes risk management, while ISO 9001 is more flexible regarding documentation requirements.
3. ISO 13485 has stricter requirements for the traceability and validation of processes than ISO 9001.

ISO 9001 vs ISO 13485

ISO 9001 is a general QMS standard that focuses on customer satisfaction and continual improvement of processes. It can be applied to any organization, regardless of size, type, or product/service offered. ISO 13485 is a QMS standard that is specially designed for medical device manufacturers.

The term ‘ISO’ in ISO 9001 is shortened from the International Organization for Standardization. It is a management system that denotes the needs required for a quality management system shortly known as QMS.

ISO 9001 has almost 8 basics to be followed and a fair number of rules. ISO 9001 is an Internationally accepted organization that sets out the standard rules or criteria for management.

The complete form of ISO 13485 is ISO 13485 Medical devices and it is also a quality management system. ISO 13485 lays out 5 key elements. There are 6 steps given to get the ISO 13485 certificate.

ISO 13485 is associated with medical devices and equipment and provides necessary services to satisfy the needs of customers.

Comparison Table

Parameters Of Comparison	ISO 9001	ISO 13485
Released	International Organization for Standardization, shortly known as ISO, released ISO 9001 in the year 1987.	The first edition of the management system, ISO 13485 was released in 1996.
Focused on	The ISO 9001 management and quality system are focused on the satisfaction of customers.	The ISO 13485 management and quality system is focused on feedback, communication, and the organization of complaints.
Fields	The ISO 9001 management system applies to all sorts of organizations and companies across the globe.	The ISO 13485 management system applies to the companies that manufacture and design medical devices.
HLS	The rules about HLS (High-Level Structure) in ISO 9001 have 10 clauses dedicated to it.	The rules about HLS (High-Level Structure) in ISO 13485 have 8 clauses dedicated to it.
Elaboration of risk	The term ‘risk’ in ISO 9001 is associated with the negative effects of uncertain events on the organization.	The term ‘risk’ in ISO 13485 is associated with the performance, safety, and improvement of the device being manufactured.

What is ISO 9001?

ISO 9001 is a management system that elaborates the required qualifications and criteria for the management system. An international agency, International Organization for Standardization developed and published ISO 9001.

This organization consists of about 160 countries.

Any working organization can adopt the ISO 9001 management system and it can be seen by observing the fact that almost 1 million organization in modern times has applied ISO 9001 management system to their work infrastructure regardless of their size.

Because ISO 9001 management system helps an organization to make improvements constantly, increase the efficiency of work.

ISO 9001 also manages the ongoing processes. When ISO launched ISO 9001, it suggested to the pre-registered companies to adopt this version as soon as possible including the companies and organizations that were under training.

In the year of 1980, the first committee was formed. ISO 9001 provides 8 basics for its customers, first basic is to focus on the fact that the customer is the main element.

Second, there should be unity of direction and purpose, the third basic is the engagement of employees, fourth signifies the importance of approach, fifth basic is constant improvement, sixth elaborates decision making, seventh basic is used to understand foster relationships, and eighth and last basic is based on the implementation of a systematic approach.

What is ISO 13485?

ISO 13485 management system was developed and launched to ensure the quality and safety of the product in the industry of medical devices. These devices can be machines, implants, vitro reagents, and other necessary instruments.

These Medical devices are used to diagnose, prevent, and treat diseases. Hence the separate version, ISO 13485 was developed for organizations and companies working in the medical industry.

This management system is adopted by those organizations that are involved in manufacturing and designing medical devices. The ISO 13485 management system took the place of pre-existing documents like EN 46002 and EN 46001.

The ISO 13485 management system has been modified several times. Unlike ISO 9001, ISO 13485 management system does not focus on the continual improvement of the organization.

It is only focused on the utilization of the quality system it has developed. ISO 13485 only looks after the implementation and maintenance of quality systems by certified companies and organizations.

ISO 13485 is one of the best management systems to control the work environment so the safety of the product is not compromised.

ISO 13485 also suggests the need for inspection of products at the right time. It can be harmonized with ISO 9001 but the core system is very different.

Main Differences Between ISO 9001 and ISO 13485

1. There are about 1 million organizations that are certified with ISO 9001 certificates. On the other hand, ISO 13485 does not have a clear number of companies.
2. Although both of them have affordable policies, ISO 9001 can be a bit expensive while ISO 13485 costs a little bit less than 9001.
3. When ISO 9001 elaborates the term ‘risk’ it emphasizes uncertain events while ‘risk’ is described by ISO 13485 to be associated with the performance and safety of the product.
4. ISO 9001 management system is based on the satisfaction of the consumer. On the other hand, ISO 13485 is more focused on the communication of customers and organizations.
5. The High-Level Structure has been described in 10 clauses in ISO 9001 documentation while ISO 13485 has given only 8 clauses to HLS.

References

1. https://www.emerald.com/insight/content/doi/10.1108/02656710910924161/full/html
2. https://dqs.hk/wp-content/uploads/2016/03/DQS-HK-Release-of-ISO-13485-2016.pdf