Why Medical Devices Manufacturers Need ISO 13485 Instead of ISO 9001

This article explains why the ISO 13485 certification is the dedicated standard for Quality Management System (QMS) for medical device manufacturers. It tells you why the general QMS standard, ISO 9001 is not ideal for the medical devices business. 

A quality assurance certification is critical for medical device manufacturers because it demonstrates that their products or devices are safe and reliable for medical treatment or diagnosis. There are several quality regulations and standards including ISO 9001 that the manufacturer of a medical device can adhere to. However, the most important of all is the ISO 13485 certification. This ISO standard is specific to the medical devices industry owing to its stringent regulatory requirements and is hence applicable to every agent in the industry supply chain. Achieving this certification helps manufacturers to give a lot of assurance to their consumers (i.e., patients, medical clinics, hospitals, doctors, diagnosis, and research laboratories). It assures that their devices are up to their quality expectations and are able to perform excellently to satisfy the customers. 

Even though ISO 13485 is the specific standard for medical device quality management, many manufacturers consider achieving ISO 9001 because it is the leading international standard for the Quality Management System (QMS) applicable to all industries. While it is true that there are quite a few similarities between ISO 9001 and ISO 13485 as both are quality management standards, a medical device manufacturer must achieve the latter. The article explains why. Let us first learn the similarities. 

 

From an overall point of view, both the ISO standards look the same as they help businesses to produce consistently quality-driven and safe products/services. Here are some of the similarities in their requirements that make manufacturers think that ISO 9001 standard is equally relevant for medical device quality management.

• Risk management and mitigation: Both the standards emphasize implementing a QMS that incorporates risk assessment, management, and mitigation practices. The risks must be identified and addressed at every stage, from designing to production and delivery of the products.

• Plan-Do-Check-Act: Both standards despite their structural differences follow the Plan-Do-Check-Act policy which ensures continual improvement of the QMS.

• Requirements for QMS: Some of the requirements of QMS mentioned in both standards are the same such as documentation, training of staff, audits, management reviews, and preventive and corrective actions implementation.

• Customer focus: Undeniably, both the standards are intended to help businesses meet the expectations of their customers and persuade them to keep coming back. 

 

The similarities might make a manufacturer think ISO 9001 is inclusive enough to fulfill the quality and safety requirements of medical devices. However, the major structural differences between the two are noteworthy and explain why ISO 13485 is required for medical devices quality management.

• Purpose/Aims: Based on the industry or industries for which the standards are built for, there are stark differences between the objectives or outcomes of the two standards. ISO 9001 is the general quality management standard meant for all, its majority of requirements are focused on ensuring customer satisfaction, the prime goal of every business. On the other hand, the ISO 13485 standard is skewed towards ensuring the safety and effectiveness of the medical devices which are primarily important for treatment and patients’ wellness. 

• Documentation Requirements: Even though document control is necessary for adhering to both standards, the requirements for documentation vary in and out for them. In fact, the document requirements for ISO 13485 are not only complex but more comprehensive than that of ISO 9001. They include processes including designing, development, production, testing, and validation of the devices. 

• Regulatory Compliance: There are many specific regulatory requirements that medical devices manufacturers need to simultaneously adhere to and which the ISO 13485 standard helps to meet. Some of the regulatory requirements that they need to meet are regarding complaint handling, post-market inspection, and maintenance of devices. 

• Comprehensive Risk Management: Even though risk management is a common aspect promoted by both the standards, medical device businesses need to adhere to more specific risk management principles in their production as well as post-production processes, including product realization and post-sales complaints. 

 

Clearly, there are structural differences between the ISO 9001 and ISO 13485 certification which make the second more inclusive and more appropriate for medical device quality management. Medical device market benchmarks products that are not only of superior quality but also assures efficacy and safety of use. No doubt, ISO 9001 is the top global standard for quality and everyone, with both large multinational companies and small-sized firms adopting it, but if you are in the medical device industry, the ISO 13485 standard must be your preferred choice because it helps you implementing a medical-specific QMS. 

 

Damon Anderson is the owner of a reputed ISO consultancy that assists organizations in various sectors to achieve their desired ISO certifications in a simplified and smooth manner. He is a consultant for the ISO 13485 certification and guides medical device manufacturers to pass through the complex stages of the certification.