The Difference Between ISO 9001 and ISO 13485

Author: Punyam Training

What is ISO 9001?

The International Organizations for Standardization (ISO) created the quality management standard ISO 9001:2015. This standard assists businesses in developing a quality management system to guarantee that their goods and services satisfy both legal and consumer criteria. Any organization, whatever its size, can use ISO 9001, and it can be implemented in any sector.

What is ISO 13485?

ISO 13485:2016 is a standard developed by the International Organization for Standardization (ISO) to guide on medical device quality management systems. This standard is designed to help businesses that design, produce, install, and service medical devices that meet customer and regulatory requirements. ISO 13485 is applying to any business involved in the manufacturing and servicing of medical devices.

What Are My Options for Selecting the Best Standard?

Selecting the appropriate standard for quality management might be difficult. To determine the best standard for your company, you must take into account your industry and particular business requirements. Our detailed article compares ISO 9001 with ISO 13485 to help you make the best choice. You may use this advice to make an informed choice and make sure your company is adhering to the appropriate quality management standard.

The Difference Between ISO 9001 and ISO 13485 Standard

Although ISO 9001 and ISO 13485 are both well-known standards for quality management systems (QMS), they have different purposes and industry-specific requirements.

  • Any organization, regardless of size or industry, can use ISO 9001 since it is a general standard. It offers a structure for creating, putting into practice, maintaining, and continuously enhancing a QMS that will assist businesses in satisfying client demands and boosting productivity.
  • ISO 13485 is a particular standard created for companies that make medical devices. Although it incorporates extra standards unique to the medical device industry, it builds upon the fundamentals of ISO 9001. Patient safety, regulatory compliance, and traceability are just a few of the particular risks and difficulties that come with producing medical equipment.
  • A primary difference between ISO 9001 and ISO 13485 is the extent of the standards. The medical device industry is the focus of ISO 13485, whereas other businesses can use ISO 9001. Furthermore, whereas ISO 9001 prioritizes customer satisfaction, ISO 13485 places more emphasis on regulatory needs.
  • Another significant distinction is that ISO 13485 has stronger documentation and record-keeping requirements than ISO 9001. Furthermore, ISO 13485 places a greater focus on risk management and corrective and preventive measures than ISO 9001.
  • Medical device terminology, clinical and performance evaluation requirements, customer feedback collection procedures, and records of corrective and preventive actions are just a few of the unique qualities that ISO 13485 provides because it is specific to the medical device industry.

While ISO 13485 is specific to the highly regulated medical device business, ISO 9001 is a global, adaptable standard that may be used in any industry. While ISO 9001 is most appropriate for more general quality management goals, organizations in the healthcare or medical device manufacturing sectors usually require ISO 13485 to satisfy industry-specific regulatory standards. Online ISO 9001 auditor training gives people the abilities, information, and resources they need to conduct internal audits in businesses. Such auditor training assesses the skills and abilities needed to successfully audit departments, activities, or processes in compliance with ISO 9001:2015 standards.