Quality Management Systems in Medical Devices with ISO 13485

What is ISO 13485? 

ISO 13485 is an international Standard that provides requirements for a Quality Management System (QMS) where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. In other words, this assists those specifically in the MedDev industry to create a QMS that ensures safe and high-quality products.

The Standard ISO 13485 specifies requirements for a comprehensive QMS and is integral to producing safe and reliable devices. It supports manufacturers in designing the systems, as well as providing direction on how to continue to maintain the effectiveness and safety of their processes and products in an ongoing fashion. Using a Standard like ISO 13485 highly increases a device's predictability, making it a valuable and safe contribution to the public's health. To read more on the power of predictability through Standards, read here.

The Standard gives step-by-step guidance for manufacturers on how to create a QMS that meets the comprehensive requirements dictated for the medical device industry. Complying with ISO 13485 allows manufacturers to demonstrate a commitment to the quality and safety of products made, as well as providing them with a foundation with which to address the EU MDR relations.

What is a Quality Management System (QMS?)

A QMS is a formal set of internal rules documenting the process structure & sequence, roles & responsibilities, policies, procedures, work instructions, and forms/templates that govern how a company addresses regulatory requirements and the end customer.

The basis of a QMS rests on documented evidence. This means that, through a regulatory lens, if a process or activity is not documented, it did not happen, meaning that proof of compliance cannot be produced to auditors or authorities. 

Standards that pertain to QMS (such as ISO 13485 and ISO 9001) are based on a 'process approach' to quality management, meaning that any activity or action that receives input and converts it to output is considered to be a process. QMSs can range from simple to complex, and ISO 13485 is applicable to them all. By deploying a matrix of interrelated processes, and their management to produce the desired outcome, a 'process approach' is formed, which ultimately reduces risk.

How is this standard different to ISO 9001? 

ISO 13485 is a standalone Standard, but was based on the broader Standard ISO 9001. The ISO 9001 Standard specifies requirements for QMS, and is the international recognised Standard for any organisation within any industry, meaning it is not industry-specific and can be used broadly. It allows organisations to demonstrate the ability to consistently make products and services that meet customer and regulatory requirements.

ISO 13485 builds on ISO 9001 and includes additional requirements that relate specifically to medical device organisations. These include:

• Documentation requirements for medical device files,

• Work environment requirements,

• Contamination control requirements,

• Production requirements for cleanliness of products,

• Production requirements for sterile medical devices, and

• Requirements for reporting to regulatory authorities.

Who needs ISO 13485? 

While ISO 13485 is not law, it's regulations are aligned with many global regulations (such as the US Food and Drug Administration) and is seen as best practice for companies within the industry.

Medical Device manufacturers are the primary users of ISO 13485, however there are many other organisations that find the Standard useful. These include MedDev suppliers, importers and distributors, as well as service providers for related activities such as technical support, installation, or related QMS services.