ISO 13485 is the internationally recognized quality management standard for medical devices. It outlines a set of quality management requirements that must be met by medical device suppliers and service providers. This article provides an overview of the standard, including its requirements, who should use it, and how to use it.
ISO 13485 structure is split into eight sections, with the first three being introductory, and the last five containing the mandatory requirements. The purpose of this quality standard is to help to demonstrate the ability to provide medical devices that consistently meet customer and regulatory requirements.
Even though ISO 13485 is a stand-alone standard, it is based on ISO 9001 standard and shares the same organization and numbering system. However, ISO 13485 also includes an extensive set of requirements specifically related to medical devices.
Below are five key requirements from ISO 13485 that are critical for companies seeking certification.
Quality Management System (QMS)
In order to receive ISO 13485 certification, a company needs to have a QMS that meets the requirements set out in the standard. This section covers the basic requirements for such a system (determine the processes and their sequences and interactions, apply a risk-based approach, etc.) as well as the documentation that is necessary for implementing and maintaining it effectively.
Management responsibility
This section explains the specific duties and obligations of management regarding the implementation and upkeep of a QMS. In essence, management must demonstrate its dedication to establishing and sustaining the effectiveness of the QMS through noticeable evidence.
Resource management
This phase outlines the resources life sciences organizations should commit to implement the QMS and maintain system effectiveness. It outlines the provisions needed to meet major regulatory and customer requirements.
Product realization
An organization must plan for the journey from conceptualization to implementation of the product. This can include developing a process for documenting how thoughts are initiated, concepts are verified, and products are designed and developed, as well as how to verify and validate to fulfill the requirements for ISO 13485.
Measurement, analysis, improvement
According to ISO, “the organization shall plan and implement the monitor, measurement, analysis, and improvement processes” related to the QMS and products.
ISO 13485 applies to medical device suppliers and medical device service providers of all kinds. It applies to organizations that participate in one or more stages of the product lifecycle, including those that design, develop, produce, store, distribute, install, or service medical devices. It also applies to external suppliers that provide products or services to these organizations.
Organizations should tailor their QMS to their environment, structure, compliance obligations, activities and processes, size and complexity, needs and objectives, and products and services. ISO 13485 does not require uniformity in the structure or documentation of QMS. Instead, it expects organizations to establish a unique QMS that meets their circumstances.
ISO 13485 is a standard set of requirements issued by the International Organization for Standardization (ISO) for creating a QMS in the medical device industry. EN ISO 13485 is the European Union version of the standard, with identical requirements but including tables that align the requirements with EU directives for medical devices. With the release of the EU Medical Device Regulation in 2017 (MDR), it is expected that a new version of EN ISO 13485 will be released to align with this regulation.
ISO 13485 is not mandatory. Even though ISO 13485 is not required for MDR compliance, the MDR regulation requires a QMS, and the ISO 13485 standard is the only QMS standard listed in EU list of harmonized standards, so most companies will use the ISO 13485 requirements to implement their QMS.
