ISO 13485 outlines the standards and requirements for a quality management system (QMS) for medical devices. From design to provision, the lifespan compliance of ISO 13485-certified medical devices is assured by its designation. 

As part of the International Organization for Standards, all medical devices bearing the certification are beholden to strict regulatory requirements. Assigned equipment must comply with a number of clauses to assure users in the healthcare industry that their mission-critical tools can pass muster.

As the ISO website so accurately claims, safety and quality are non-negotiable when it comes to the tools and devices tasked with helping save lives. If you’re looking to manufacture one of the healthcare community’s dependable assets, this guide will help walk you through the entire process. 

It’s time to examine the importance of the ISO 13485 label and how its implementation standardizes and simplifies your medical device’s certification. 

Understanding the importance of ISO 13485

In order to understand how ISO 13485 protects the integrity of medical device manufacturing, we’ll follow the oversight involved with the creation of a tool in accordance with the standard. But before we do, here’s a little overview of why medical tools and equipment require this literal seal of approval.

Firstly, it’s important to understand that ISO 13485 is not a standard that regulates product quality. Rather, it encompasses a process-based workflow that results in an end product that is guaranteed to meet its desired results. 

In this respect, a commitment to ISO 13485 is an important part of a QMS. Manufacturers follow the steps in alignment with the creation of medical devices, knowing that their products will be able to assist medical professionals in their potentially life-saving implementations. 

This certification is accomplished by strict adherence to the documentation procedures that accompany each phase of the product’s manufacturing process. Each medical device type or family must be recorded via relevant documentation, with a clear understanding of how the created device will fulfill its intended purpose in accordance with regulatory requirements.

That means that a quality policy is observed as the device is planned and created, and a management representative performs an internal audit to review the documentation and ensure that the job is accomplished thoroughly and to standard. 

No matter the size of the manufacturer, each medical device must bear the ISO 13485 stamp of approval. What’s more, for every three years of active service, the device must be recertified in order to maintain this important quality control initiative. 

Now that we’ve covered why this ISO designation is so important, let’s walk through the 8-step process associated with certification.

What are the ISO 13485 requirements?

Here’s how the ISO 13485 regulatory compliance protocol works. Our comprehensive guide to the 8 clauses associated with the creation and certification of a tool will provide you with all you need to know regarding how a medical device makes its way through the front door of a healthcare facility to begin active duty. 

Before we cover the 8 clauses, here are three of the most important questions to ask when beginning your certification.

What is the latest ISO 13485 Revision?

As reported by 13485 Academy, the latest revision of ISO 13485 was released in 2016. A manufacturer conceptualizing a device is well-served by downloading the latest ISO 13485 templates and reading about how their company can successfully execute its vision in accordance with the outlined requirements. 

If you’re looking to get started, the ISO website has provided a library of necessary resources, including information on how to upgrade from the previous iteration, ISO 13485:2003, if needed. Understanding the requirements and risk management associated with the creation of your device will help streamline the process.

Does your manufacturing process meet the standard?

Are there areas of your current quality policy that don’t quite meet the ISO 13485 standard? Taking a moment to consider the vulnerabilities of your current manufacturing process will save you headaches once you get started. 

Have you planned your manufacturing steps accordingly?

Now that you’ve reviewed the applicable regulatory requirements of ISO 13485 and filled any potential gaps that may prevent certification, you’re free to focus on the design aspects of your device. Is every nut, bolt and associated part accounted for? The medical community is depending on every facet of your tool being up to regulatory standards. Is the infrastructure and work environment ready to begin manufacturing? Have you arranged to prevent any possible contamination? A Project Manager’s Guide can help walk you through these steps. 

The eight clauses of ISO 13485 

You’ve assessed your work environment, reviewed the guidelines and created an oversight architecture to check and double-check your work. Without further ado, here are the eight quality system regulation clauses that comprise ISO 13485 certification.

Clause 1: Scope

This standard covers all stages of your product’s lifecycle, including design, production, storage, distribution and technical support. This particular QMS gives an overview of how you’ll handle each of these important aspects and ensures a manufacturer understands their involvement beyond a product’s creation. 

Clause 2: Normative references

Each of the documents referenced, in whole or in part, are designated as indispensable for your product’s use application. Be sure to include all of the necessary documents, including any amendments. 

Clause 3: Terms and definitions

For reference, any of the terms and definitions outlined as part of the ISO 9000:2015 QMS are to be included. 

Clause 4: Quality Management System

The specific requirements of your ISO 13485 begin here. This introductory section outlines the standards you need to meet for your medical device. Here, you’ll show how to develop your device, and how you’ll report each step of its creation. All relevant documents must be included and controlled.

Clause 5: Management Responsibility

Here you’ll define your responsibilities and authorities. You’ll show your commitment to establishing and maintaining your QMS. Who in your organization will be effectively operating the organization in accordance with the standard? Who is your management representative in charge of reviewing the device?

Clause 6: Resource Management

Identify the people and jobs that will affect the quality of your device. Here is where you’ll ensure that your work environment is up to standard and that the workforce responsible for creating your product are competent and skilled.

Clause 7: Project Realization

This particular clause is a big one, encompassing all aspects of the creation and distribution of your medical device. Here you’ll set product quality objectives, identify product realization requirements and establish how you’ll communicate with customers and regulators. By providing this verification and validation, you’ll set the stage for any purchasing by identifying suppliers and planning your product purchase standards. In addition, you’ll define requirements for things like contamination control and develop installation and servicing protocols for when your devices are in the field.

Clause 8: Measurement Analysis and Improvement

How will you measure the conformity of your product in accordance with the QMS? How are you investigating complaints and resolving customer issues? What do your internal audits look like? All of these questions are to be answered here, in the final clause of your ISO 13485 certification. 

DISCUS aids healthcare inspection protocols

ISO 13485 certification covers a great deal of the manufacturing, distribution and maintenance of the medical devices sector, and for good reason. We’ve outlined the importance of these controls for your end users and showcased what it takes to achieve and maintain certification. 

A certification audit that identifies areas of noncompliance could be slow production and take time for recertification. Following an audit report that lists any minor or major nonconformities, you’ll have a timeframe to conduct the necessary corrective actions. 

To ensure your device meets and maintains ISO 13485 compliance requirements, DISCUS offers a free download of a medical device manufacturing inspection sheet. We understand that designing, manufacturing and maintaining health industry devices in accordance with the 2016 revision can be daunting, so we created what we hope will be a helpful sheet. 

Our aim is to make the process a little easier and less time-consuming — for further assistance, get in touch with our team to learn more about how aid organizations achieve their inspection planning goals.