ISO 9001 and 13485

What is the Difference Between ISO 9001 and 13485?

The Differences Between ISO 9001 and 13485

ISO 13485 is a quality framework tailored for the medical device field, which includes ISO 9001 and additional requirements. Nevertheless, numerous manufacturers of medical devices overlook the significance of evaluating and contrasting ISO 9001 and ISO 13485.

By understanding the differences between ISO 9001 and 13485 standards, one can pinpoint the specific areas where device manufacturers need to improve their quality standards.

What is ISO 9001?

ISO 9001 is a comprehensive quality management standard that can be applied to businesses across various industries, regardless of size or structure. Its purpose is to provide organizations with the fundamental building blocks to establish an effective quality management system.

Certification serves as evidence that your business has integrated essential elements of quality management into its operations, which encompass:

  • Customer focus principles, leadership involvement, and constant improvement 
  • Adopting a process-oriented mindset, like the Plan Do Check Act approach. 
  • Considering risk as a critical factor in decision-making.
  • Making decisions based on solid evidence.

What is ISO 13485?

ISO 13485 surpasses standard expectations by centering on a specialized strategy customized to ensure the quality management of medical devices rather than having a broad application encompassing all types of businesses.

Due to the critical nature of medical devices and their potential to save lives, their requirements are inherently more rigorous when compared to industries such as window manufacturing or furniture businesses.

Primary Differences Between ISO 9001 and 13485

ISO 13485 and ISO 9001 differ mainly in their scope for medical devices. ISO 9001 applies to any industry, while ISO 13485 medical devices are specifically for medical device manufacturing, emphasizing regulatory compliance and having less organizational flexibility.

Medical device manufacturers face additional responsibilities when establishing a robust 

quality management system (QMS). These obligations encompass various areas such as management, efficient utilization of resources, the execution of product realization, and other related aspects.

ISO 9001 and 13485


ISO standards define a QMS as a set of policies, processes, and procedures for planning and executing core business activities. An ISO-compliant eQMS software supports these policies and procedures. Organizations must meet all standard requirements, including documentation, to obtain certification or a CE mark.

ISO 13485 expands on ISO 9001 by focusing on the device manufacturer’s responsibility for preserving the QMS’s effectiveness.

Management Responsibility 

ISO 9001 lets management assign quality duties without defined roles, while ISO 13485 requires identifying a responsible manager for each QMS aspect.

Medical device manufacturers must commit to compliance and review new cGMP regulations under ISO 13485.

Resource Management 

ISO 9001:2015 and ISO 13485:2016 emphasize resource management, including equipment, buildings, and IT resources for quality product realization. Device makers must adhere to particular ecological criteria and protocols for managing contamination in order to guarantee the safety of their products.

Product Realization 

ISO 9001 emphasizes efficient methods and rules to achieve high-quality product outcomes that meet customer requirements. 

On the other hand, ISO 13485 offers more comprehensive instructions concerning safety, customer contentment, and quality at every stage of the product’s lifespan, encompassing process validation, equipment, cleanliness, and risk management.

It supplements ISO 9001 by introducing particular production and supply chain criteria while upholding the significance of policies, procedures, and customer satisfaction.

Measurement, Analysis, and Improvement  

ISO 9001 focuses on improving processes, while ISO 13485 medical devices specify safety and effectiveness improvements for device manufacturers. Key differences include customer feedback, product performance monitoring, and handling non-conforming products.

Electronic QMS for ISO 13485 Compliance

Comparing ISO 13485:2016 and ISO 9001:2015 highlights the rigorous steps medical device makers must take for quality assurance. 

ISO 13485 expands on ISO 9001 by adding extra demands for efficient management, documentation, and measurement to ensure the production of safe medical devices. 

Using an eQMS tailored for medical device manufacturers can simplify the process of meeting these specific requirements for data capture, retention, and documentation.


In summary, ISO 9001 and ISO 13485 are quality management standards. ISO 9001 applies to various industries, emphasizing customer focus and continuous improvement, while ISO 13485 is specifically for the medical device industry, focusing on regulatory compliance and unique quality management needs. 

Adhering to ISO 13485 is crucial for medical device manufacturers to meet regulations and ensure product quality and safety. Implementing an eQMS designed for medical devices simplifies compliance and improves workflow efficiency. 

Understanding the differences helps identify areas for quality improvement and regulatory compliance. Choosing ISO 13485 medical devices will be a more logical option for global medical device companies.

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