Difference between ISO 13485 and ISO 9001 Certification

ISO 13485 Certification is quality management for medical devices shares many similarities and differences with ISO 9001 Certification, the leading quality management standards developed by the International Organization for standardization.


While most revised standard follows ISO 9001’s new high-level structure Annex SL Structure, but ISO 13485 does not follow HLS, even though it was released after ISO 9001 Certification standard.
Today we’re viewing some similarities between these two ISO standards, and few areas major in which ISO 13485 and ISO 9001 get differentiated from one another.

What Is ISO 13485?

An ISO standard that has been specifically designed and published for the safety and quality assurance of medical devices and related industries. This has successfully implemented the rock-solid instrument to all the manufacturers or producers of Medical Device industries for achieving reliability, trust, and unbreakable commitment from their end-user and customers to human safety and the quality of medical devices being manufactured and their acceptance worldwide.

What ISO 9001 Implies?

ISO 9001 is one of the international standards too developed and published by the International Organization for Standardization that has vividly specified the guidelines to establish, maintain, monitor, and continual improvement in a Quality Management System (QMS) of an organization.
Also, Check —->> ISO 13485 Certification in Sri Lanka

Similarities Between ISO 9001 and ISO 13485

When you get down to brass tracks, ISO 9001 Certification and ISO 13485 Certification are both essentially and identically similar. These both standards act as a helping hand to companies for creating consistently safe, high-quality products for the consumer and end-user. ISO 9001 also shares other similarities with ISO 13485, such as:

  • Risk identification and risk mitigation: More so than previous versions, both these ISO standards highlight the need for organizations to incorporate risk involved in design and production and mitigate earlier.
  • Plan-Do-Check-Act: Even though the two standards do not share the same structure, but they both use the Plan-Do-Check-Act process approach system for implementation.
  • Customer-oriented: Both ISO 9001 and ISO 13485 are built around ensuring customer satisfaction and meet their requirements and expectations.
  • QMS requirements: To comply with either standard, organizations will require effective processes, maintain quality and enhance quality and tools for Documents, Employee Training, Internal Audits, and Corrective Action.

Differences Between ISO 9001 and ISO 13845

Even though they are similar in various terms, it’s important to note that there are significant ways in which these two are different.

  • Aims and outcomes: ISO 9001 Certification requirements are skewed heavily towards ensuring customer needs and satisfaction of their requirements, while ISO 13485 Certification puts more emphasis on the safety and efficacy of medical devices with the concern of public health.
  • Continuous improvement focus: ISO 9001 now requires manufacturers to show continuous improvement in the management system. ISO 13485, on the other hand, only requires demonstrating effective implementation and maintenance of the quality system by improving the devices as per advanced technology.
  • Documentation: ISO 13485’s documentation requirements are much more extensive, as they relate to public health and safety than those in ISO 9001.
  • Risk management: Organizations certifying to the ISO 13485 medical device standard will also need to incorporate risk management principles into product realization and post-market feedback after the usage.
  • Regulatory compliance: ISO 13485 is closely linked to regulatory requirements, especially concerning complaint handling systems due to defaults and errors in the devices, regulatory notifications, and post-market surveillance.

Do You Need Both Certifications for your organization?

Situations where you might consider certifying to both certificates just when medical devices represent just part of your business. For ex. organizations providing medically related services such as contract manufacturers, suppliers or distributors might need to certify to ISO 13845 Certification as well as ISO 9001 compliance.

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