What is the ISO 13485 Quality Manual?

Did you know that medical devices are among the most highly regulated products?

Some medical devices, including those within Class II and Class III categories, can cause lasting damage to users if quality assurance protocols are not followed.

Title 21 of the Code of Federal Regulations (CFR) outlines specific premarket and postmarket requirements, including testing, production, quality assurance, and more. A quality manual guided by ISO 13485 best practices is a valuable tool that medical device manufacturers can use to achieve rapid FDA 21 CFR compliance.

This begs the question: What are the components of an ISO 13485 quality manual?

In this article, we’ll identify the key elements of an ISO 13485 quality manual. We’ll also outline the step-by-step procedures to build an ISO 13485 quality manual so that your life sciences startup or scale-up can build an advanced medical device or pharmaceutical product that complies with all major FDA quality laws and regulations.

An Overview of the ISO 13485 Quality Manual for Life Sciences

The International Organization for Standardization (ISO) is an internal standard-setting group of representatives from national standards organizations.

This group maintains a comprehensive set of standards for life sciences organizations. These standards are commonly referred to as ISO 13485 standards. The current version of ISO 13485 (last updated in 2020) sets forth major manufacturing and quality guidelines for businesses in highly regulated industries.

To mitigate unforeseen danger and uphold universal quality control standards across the medical device manufacturing industry, an ISO 13485 quality manual outlines the mission-critical quality control guidelines and QMS requirements needed to keep both users and manufacturers safe.

Who Benefits from the ISO 13485 Quality Manual? 

A quality manual serves as the road map for regulators and customers to gain an in-depth overview of your quality management system (QMS) and how it works.

The ISO 13485 manual enables organizations involved in the design, production, installation, and servicing of medical devices and related services to maintain quality standards. Additionally, internal and external parties, such as certification bodies, also consult quality manuals for informing their basic auditing processes. 

By using ISO guidelines to build your quality manual, your organization will be able to meet all applicable regulatory requirements and achieve ISO certification.  

An ISO quality manual is universally useful for upholding a culture of quality practices and procedures within your growing life sciences organization.

Purpose of an ISO 13485 Quality Manual

The quality manual is a guide that outlines the scope of your organization’s QMS. It's a mandated method to ensure you're adhering to specific regulations and requirements within your process. 

The ISO contains five applicable clauses related to medical device manufacturing and quality control. All five clauses of the ISO should be included inside of your manual:

  • Clause 4: Quality Management System Requirements
  • Clause 5: Management Responsibilities
  • Clause 6: Resource Management
  • Clause 7: Product Realization
  • Clause 8: Measurement, Analysis, and Improvement

RELATED READING: 5 Objectives of Quality Assurance in the Pharmaceutical Industry

Elements of an ISO 13485 Quality Manual

A well-designed ISO 13485 quality manual is designed to capture all relevant regulatory information, including laws and regulations, quality management procedures, and key structural processes, in a single, comprehensive, and easily accessible document.

Your organization’s quality manual should describe the overall scope of the QMS. Be sure to list standard quality procedures. As a best practice, consider including a visualization of all quality procedures via a flowchart.

By visualizing your QMS hierarchy using a flow chart, you can define key relationships between QMS processes. Be sure to define the scope of your QMS, including any regulatory exclusions. Detail your standard operating procedures (SOPs) and provide an outline of QMS documentation best practices.

Only keep information that is vital, pertinent, and useful to the use and maintenance of your QMS—that’s it. The ISO 13485 quality manual should be easy to understand but robust enough to demonstrate your organization’s clear commitment to ISO/QMS standards.

New call-to-action

Benefits of an ISO 13485 Quality Manual

A comprehensive ISO 13485 quality manual serves as the navigational blueprint for employees, clients, regulators, and others that come in contact with your life sciences startup or scale-up. Additionally, an up-to-date ISO 13485 quality manual ensures that your organization’s QMS never falls below standards.

Another benefit of the ISO 13485 manual is the promise of increased client confidence. Some customers won't even ask to see more SOPs if they have proof of an active ISO certification and access to a quality manual. From an operational standpoint, taking the time to compile this collection of documentation is well worth the time and effort.

RELATED READING: How to Create and Implement an Effective Quality System Plan

How to Find the Right QMS for Your Life Sciences Organization

The ISO 13485 quality manual serves as a central repository of information related to your QMS. The document should provide a comprehensive overview of all strategic and operational procedures of the QMS. 

Additionally, an effective ISO 13485 manual and QMS play a significant role in building and fostering a culture of quality throughout your life sciences organization. And because this document is reviewed by both employees and auditors, it’s important to create something that can be easily consumed by both internal and external parties.


For the best results, consider investing in an eQMS that ships with advanced document management features. The utilization of an enterprise-class QMS enables your organizations to meet or exceed regulatory requirements for document control and create a set of accessible guidelines for your entire workforce.

To maximize the effectiveness of your QMS and help you find an ideal solution, we’ve created a simple guide: 12 Questions to Ask Before You Buy an eQMS. If you’re looking to unlock the key insights needed to make an informed and data-driven QMS purchase, you’ve got to check it out.

New call-to-action