5 Real Differences Between ISO 9001 and ISO 13485

What are the differences between ISO 9001 and ISO 13485?

ISO 9001 is an international standard for a quality management system. ISO 13485, on the other hand, is the standard focused on the effectiveness and quality of medical devices.


There are a lot of similarities between ISO 13845 and ISO 9001 that focus in on the goal of producing high-quality products. 

ISO 13485

5 Differences Between ISO 9001 and ISO 13845

There are significant differences in the structure and aim of these systems.

  1. Product specifics
  2. Regulatory requirements
  3. Documentation requirements
  4. Customer satisfaction
  5. Continual improvement

ISO 13845 documentation requirements are much more thorough than that of ISO 9001. Companies certifying medical devices must include a risk-assessment in the product realization.

Clinical performance evaluation is a part of design and development validation. It has to be in line with regulatory requirements for the ISO 13845 quality management system.

Documentation for Each Medical Device

  • General description
  • Product specification
  • Manufacturing process
  • Installation processes
  • Servicing processes

The release of out-of-date documents is required for the lifetime of a medical device. Responsibilities and authorities must be recorded in addition to being defined and described. Any relations among personnel must be documented.

Maintenance of activities that affect product quality, communication of health, clothing, and contamination.

Installation activities, including confirming, and servicing projects, must be documented. Manage reports and documents for every sterilization batch.

Document procedures for validation of computer software, validation of sterilization, product identification including returns and traceability. Document procedures for traceability are required.

Documentation for implantable medical devices is to include components, materials, and work conditions as well as records of the identifying personnel performing the inspection.

Preserving conventionality of the product is a requirement in order to control measuring and monitoring devices including software that affects product conformity. There also is a feedback system for early warning of all quality problems.

Complaints must be examined in response to customer feedback, which includes the authorization of documentation when remedial actions are not taken.

Medical devices

Medical Devices are Subject to Very Rigorous Standards

The ISO 13845 is subject to much more rigorous standards due to the application of the products. Medical devices have their own unique terminology within the industry.

There are specific rules and qualifications staff members must be aware of to avoid contamination. Unlike ISO 9001, ISO 13485 is concerned about the cleanliness and contamination control of their products.

When it comes to regulatory requirements, the purpose of the standard is to expedite the effectiveness of quality management system regulations around the globe.

Meeting product handling requirements is also an essential component of this standard, as the plan is to produce reliable products which have adequate performance.

It is both an international and national standard for all staff to be well-versed in the protocol. The Intent is to monitor information in order to meet customer satisfaction.

The ISO 9001 Standard Follows Basic Quality Principles, Such As:

  • Customer focus; the 9001 system's main focus is customer satisfaction
  • Leadership within the confines of the company creates unity and organization among the ranks
  • The engagement of people ensures the customer's needs are understood and met in regards to the ISO standard
  • The desired result is achieved when activities are considered a process
  • Logical decision-making that suits the interest of the company and consumer likewise is needed
  • Management must select suppliers that increase value, limit waste, and optimize cost efficiency
  • ISO 13485 requires a representation of efficient implementation and maintenance of the quality of the system

Unlike most systems in the ISO 9000 family of systems, the structure of ISO 13845 is not compatible with other systems within the family.


ISO 13485 Certification

ISO 13845 does require certification yet, a third-party source certification would be quite beneficial. There are special qualifications that a quality management system needs to engage to become certified.

Each organization needs to show its own capacity to produce medical devices and services that meet customer and regulatory demands.


Written: 28 April 2024
Author: Richard Keen

Richard Keen

Richard Keen

Richard is our Compliance Director, responsible for content & product development.
But most importantly he is ISO's biggest fanboy and a true evangelist of the standards.
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