ISO 13485 was first introduced in 1996 by the International Organization for Standardization (ISO).
It has been updated over time to keep up with the changing needs of the medical device industry, with revisions in 2003 and 2016. The latest version is ISO 13485:2016.
Based on general quality management standards, ISO 13485 is specifically designed to meet the regulatory and risk management needs of medical devices. It aims to improve quality management throughout the medical device sector and applies to all stages of a device’s lifecycle, from design to servicing.
ISO 13485 is a widely recognised standard in the medical device industry. It helps organisations deliver quality and enhance safety in their products and processes.
ISO 13485 provides guidelines for setting up a Quality Management System (QMS) specifically for the medical device industry, focusing on important areas that support the development of safe and effective products.
Scope – Clearly outline your organization’s goals and how your work relates to the quality and safety of medical devices.
Leadership – Management must actively support and commit to the QMS and follow regulatory requirements.
Risk management – Identify and control risks throughout the product lifecycle for device safety and effectiveness.
Resource management – Provide enough resources, trained staff, and proper facilities for developing and producing devices.
Product realisation – Efficiently manage processes from design to delivery to meet regulatory and customer requirements.
Performance evaluation – Monitor the effectiveness of the QMS and identify areas for improvement through audits and data analysis.
Continual improvement – Focus on ongoing enhancements to processes and quality management for regulatory compliance and performance.
These requirements help build a framework that helps businesses maintain high-quality standards, product safety and regulatory compliance.
ISO 13485 certification demonstrates that your organisation’s Quality Management System meets the requirements of the ISO 13485 standard. It assures customers, partners and regulators that you consistently deliver safe and effective medical devices.
Certification centres on your QMS, with an independent body evaluating your processes, policies and procedures. If they comply with ISO 13485, they receive a certificate that must be renewed periodically to maintain compliance.
To get certified, follow these steps:
Before undergoing the certification process, proper preparation could help you start in a better place and make your efforts more successful.
ISO stands for the International Organization for Standardization.
It is an independent, non-governmental international organisation that develops and publishes standards for the quality, safety, efficiency and interoperability of products, services and systems across various industries worldwide.
ISO 13485 and ISO 9001 are both quality management standards, but they serve different industries.
ISO 13485 is specifically designed for the medical device sector, focusing on regulatory requirements and risk management related to the design and manufacture of medical devices.
ISO 9001 is a broader standard applicable to any industry. It emphasises customer satisfaction, continual improvement and operational efficiency through the use of a Quality Management System.
While both standards share similar principles, ISO 13485 places a greater emphasis on meeting regulatory compliance and ensuring safety and effectiveness in the design, manufacturing and distribution of medical devices.
No, ISO 13485 does not replace ISO 9001.
While both are quality management standards, they serve different purposes and industries. ISO 13485 is tailored specifically for the medical device industry, focusing on regulatory compliance and safety, whereas ISO 9001 is a general standard applicable to any industry, emphasising customer satisfaction and continual improvement.
Organisations in the medical device sector may choose to implement ISO 13485 to address industry-specific requirements, but this does not negate the relevance of ISO 9001, which provides a broader quality management framework.
ISO 13485 is not a legal requirement by itself, but it is often used to demonstrate compliance with regulatory requirements for medical devices in various countries.
Many markets, including the European Union, Canada and Japan, recognise ISO 13485 as a means of fulfilling their regulatory obligations.
Obtaining ISO 13485 certification can be helpful for manufacturers looking to enter these markets, as it helps them to demonstrate that their products meet specific safety and quality standards.
ISO 13485 certification is typically valid for three years.
During this period, certified organisations must undergo regular surveillance audits, usually annually, to verify continued compliance with the standard’s requirements.
At the end of the three-year cycle, a recertification audit is conducted to assess the organisation’s ongoing adherence to ISO 13485 and to renew the certification for another three years, provided all criteria are met.
