ISO 13485:2016

Medical Device Safety

ISO 13485 provides a comprehensive framework for medical device manufacturers to ensure product quality and regulatory compliance.

Overview

In the highly-regulated world of medical device manufacturing, organisations have a duty to show that every device meets both customer expectations and applicable regulations. SQNet supports clients in their efforts to meet the stringent requirements of ISO 13485, fine-tuning product development lifecycles to ensure a timely market launch.

The international quality management system (QMS) standard for medical devices, ISO 13485:2016 (Medical Devices - Quality management systems - Requirements for regulatory purposes) was published 1 March 2016, with the International Accreditation Forum (IAF) allowing certified organisations three years to transition from previous versions. ISO 13485:2012 maintains its status as the harmonised standard and the presumption of conformity until the end of the transition period.

ISO 13485:2016 introduces a host of subtle, yet detailed, changes requiring more thorough documentation on the work environment, risk management, design control and regulatory requirements. The revised standard includes the need for a risk-based approach to the QMS, an enhanced focus on regulatory requirements and the responsibilities of top management, increased controls over suppliers and outsourced activities, and an emphasis on risk management throughout the product lifecycle.

ISO 13485 applies to both manufacturers of medical devices and organisations that support medical device manufacturers. It underpins the manufacturers' duty of ensuring devices consistently meet customer and applicable regulatory requirements.

The updated ISO 13485:2016 replaces all previous versions in March 2019.

Benefits of ISO 13485

Freedom to trade
Many manufacturers require suppliers to have ISO 13485 certification, making the standard a pre-requisite to remain competitive.
Consistent quality
Patient safety depends on the quality of medical products. ISO 13485 certification gives manufacturers confidence that organisations throughout the supply chain can achieve and maintain compliance.
Risk management
Gaining certification to ISO 13485 is a proactive method to prevent incidents and prioritise patient safety. This helps minimise the risk of reputational damage to manufacturers caused by product defects.