ISO 13485 vs ISO 9001: All the differences

In the medical device space, maintaining the highest standards of quality and safety is paramount. One pillar in this effort is establishing an effective Quality Management System (QMS). With this in mind, two main standards exist today: ISO 13485:2016 and ISO 9001:2015. In this comprehensive guide, we delve into the nuances of these standards, exploring their significance, key requirements, and the similarities and differences between both.

ISO 13485

ISO 13485 is a globally recognized standard specifically tailored for organizations involved in the design, development, production, installation, and servicing of medical devices and related services. It outlines requirements for a quality management system (QMS) that emphasizes regulatory compliance and product safety. 

ISO 9001

ISO 9001 is a universal quality management standard applicable to organizations across all industries. It sets forth requirements for establishing, implementing, maintaining, and continually improving a QMS to enhance customer satisfaction and drive organizational performance. While ISO 9001 is not industry-specific, its principles can be applied to various sectors.

What do the ISO 9001 and ISO 13485 standards have in common?

Historically, ISO 13485 was developed based on ISO 9001. However, over time, with new revisions, it became a fully independent standard which no longer refers to ISO 9001. However, that doesn't mean there are no more similarities between both.

Some of the key similarities are:

• They both provide a framework to organizations to set up and maintain a quality management system

• In doing so, they both also take a risk-based approach

• Both standards follow a plan-do-check-act cycle

• The customer needs are a key focus point within both standards

• Both standards focus on employee competencies and infrastructure

ISO 13485 and ISO 9001 for medical devices: how they differ?

Although they have a common scope, being providing requirements for a quality management system, both standards have also there specificities.

Quality Management System

ISO standards delineate a Quality Management System (QMS) as a comprehensive framework encompassing "policies, processes, and procedures" essential for orchestrating and executing core business operations. Often, these policies and procedures find support through ISO-compliant electronic Quality Management System (eQMS) software. To attain certification or a CE mark, organizations must diligently adhere to all stipulations within the standard, including meticulous documentation.

Expanding upon the requisites of ISO 9001, ISO 13485 places particular emphasis on the device manufacturer's accountability for "upholding the efficiency of the quality management system." Notably, ISO 13485 surpasses ISO 9001 in several domains, particularly in documentation and records management.

• Integration of regulatory documents into the system documentation

• Incorporation of a medical device file delineating product specification documents within the QMS

• Implementation of a rigorous review and approval process for alterations to QMS documentation by either the original approver or a designated individual possessing sufficient background knowledge

• Requirement for changes to be scrutinized and approved by either the original approving function or another identified individual equipped with adequate subject matter expertise

By meticulously integrating these provisions into their QMS, organizations can fortify their compliance with ISO 13485 standards, thereby ensuring the integrity and effectiveness of their quality management systems within the medical device industry.

Management responsibility

Where ISO 9001 allows the organization's management team to assign quality responsibilities without defining roles, ISO 13485 requires to identify who is responsible for which aspect of the QMS. Furthermore, it requires top management commitment to regulatory compliance in several ways such as e.g. reviewing regulatory updates during management review meetings.

Resource management

Even though both standards have requirements for resources, ISO 13485 obviously is more specifically tailored to the medical device industry with e.g. requirements about cleanliness, contamination control, but as well maintenance related activities.

Product Realization

The main focus of ISO 9001 are customer needs and customer satisfaction as a measure of quality. ISO 13485 on the other hand focuses more on ensuring product safety. Validation of processes, software, risk management, etc. throughout the product life cycle are critical factors of quality

Measurement, analysis and enhancement

When it comes to measuring and improving the quality management system, ISO 9001 takes a process-driven approach that is focused on continuous improvement. ISO 13485 is more focused on improvements related to ensuring the product is and remains safe and effective.

A quality management system is one of the key components to obtain market approval for medical devices. It can sometimes be confusing which standards apply to your organization. In the case of quality management systems and medical devices it's clear that ISO 13485 is the way to go. If you'd like to know how Matrix can help you with this, don't hesitate to book a demo!