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Key Differences between ISO 13485 and ISO 9001 for Medical Devices

06 Dec 2023
Key Differences between ISO 13485 and ISO 9001 for Medical Devices


Different industries use different quality management standards to cater to their unique requirements. Even within the industry, different ISO standards are used for varied purposes. For example, ISO 13485 is a global set of standard quality management systems for a company involved in the design, production, installation, servicing, and manufacturing of medical devices, while ISO 9001 helps organizations of different sizes and sectors to scale their performance, demonstrate their dedication to quality, and meet customer expectations.

What is ISO and Why Is It Crucial in the Medical Industry?

Quality is indispensable in dynamic industries such as pharmaceuticals. Quality management software ensures adherence to modern quality principles and safety. ISO, an abbreviation for International Organization for Standardization, plays a pivotal role in guaranteeing safety and quality in the medical industry. It will be easier to conform to high-quality benchmarks in the medical sector with ISO standards.

ISO standards enforce a universally accepted set of standards at every step of quality management. It ensures that the medical industry and healthcare providers offer consistency and excellence in their services. Deviation from set ISO standards can adversely impact, causing even deaths.

Adherence to ISO standards instills confidence in patients and other stakeholders, ensuring transparency in the industry. Additionally, in a world characterized by rapid medical advancements, ISO regularly updates its standards to reflect the changes and provide best practices. Updating ISO standards cultivates a culture of continuous improvement and innovation, guaranteeing safety to all.

What do ISO Standards Cover?

ISO standards cover different areas in the medical industry. Adherence to ISO standards enables management of equipment, manufacturing processes, information, etc.

Key Difference in ISO 13485 and ISO 9001 for Medical Devices

ISO 13485 and ISO 9001 are used in the medical device industry, and both are responsible for maintaining the highest standards of quality in the industry. There are some key differences between the two, and it is crucial to understand the differences for a holistic understanding of their functions and importance in the medical device industry.

  • (1) ISO 9001 is a general quality management standard. It can be applied to any business, regardless of size or industry. It offers specifications for a quality management system, including customer engagement, continuous improvement, a well-established process, risk management, data-driven decision-making, etc. ISO 13485, on the other hand, is not a general quality management standard. It is a comprehensive management system designed specifically for the manufacturing of medical devices. The framework of ISO 13485 ensures that the manufacturing of medical devices meets regulatory requirements without exception and produces effective and safe products. Qualityze CAPA – Corrective and Prevention Action—software ensures you meet regulatory requirements without deviation. It builds quality management into your manufacturing process, ensuring the effectiveness and safety of products.
  • (2) ISO 13485 emphasizes regulatory compliance. It strictly enforces regulatory requirements in the medical device manufacturing industry, ensuring the safety and effectiveness of products. Qualityze’s suite of EQMS products, such as CAPA, Nonconformance, Risk Management, Audit, Management, Field recall Management, Calibration Management, Change Management, Permit Management, Document Management, etc., streamline your quality management and helps you meet specific requirements laid down by ISO 13485.
  • (3) ISO 9001 doesn’t have additional requirements indispensable to ISO 13485. IS0 13485 demands medical device manufacturers establish and maintain a system for validating software used in the QMS or quality management system. There are no such requirements for ISO 9001 as it is not specific to any industry.
  • (4) ISO 13485 incorporates risk management specifically related to medical devices. However, the ISO 9001 scope of risk management is in broad organization content. In other words, the ISO 9001 focus is not singularly on the medical device industry.

Qualityze’s Risk Management software analyses risks and offers robust risk mitigation solutions. Using Qualityze’s Risk Management software, you can build risk management into your medical device manufacturing process, complying with regulatory requirements.

  • (5) ISO 13485 has specific documentation requirements as it takes care of the design and development of medical devices. There is no room for flexibility in documentation as it may lead to standard deviation, lowering the quality of medical devices. There is no such restriction in ISO 9001. ISO 9001 tolerates flexibility in documentation.

Document management is a dynamic process and demands constant attention and resource commitment. Qualityze’s Document Management software takes care of specific documentation requirements in the design and development of medical devices, enabling your organization to meet the standards of ISO 13485.

  • (6) ISO 13485 addresses specific requirements for designing and developing medical devices, whereas ISO 9001 covers a broad concept of product realization.
  • (7) Both ISO 9001 and ISO 13485 adopt a process approach. However, the difference lies in their approach to risk management. ISO 13485 demands risk management at every stage of the product lifecycle, whereas there is no such approach in ISO 9001.
  • (8) The traceability of the product is paramount in ISO 13485 standards. It ensures the ability to trace each unit to its source.

Qualityze’s Document Management and electronic Batch Records modernize your records, enabling you to trace the origin of every unit of product to its primary source.

  • (9) The focus of ISO 9001 is on customer satisfaction through monitoring and measurement. On the other hand, ISO 13485 puts extra emphasis on processes specific to medical device manufacturing.

Qualityze’s Complaints Management software is a cost-effective and efficient way to optimize customer satisfaction. Using the Complaints Management software of Qualityze, you can monitor and measure customer satisfaction rates and make changes accordingly for better results.

Parting Shot

Both ISO 9001 and ISO 13485 are concerned with quality management in the medical device industry. There are some similarities between the abovementioned ISO standards, but understanding their key differences is crucial to modernizing your medical device manufacturing processes. ISO 9001 is a generic quality management standard that applies to different businesses across industries. ISO 13485 is a comprehensive quality management standard for medical device manufacturing.

Qualityze’s suite of EQMS organizes your medical device manufacturing process, empowering you to meet standards set by ISO 13485 without exception and deviation.



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