ISO 13485 – Certification for Medical Device Manufacturers

A Quality Management System

The ISO 13485 standard is for manufacturers of medical devices or medical device components. Due to the vital nature of products manufactured for medical use, product conformity of medical devices is paramount. The global acceptance of ISO 13485:2016 helps safeguard product conformity as manufacturing supply chains have expanded nationally and internationally. For an overview of ISO 13485 download the free information sheet.

The processes for design and manufacturing of medical devices is the subject of this standard. It references the ISO 9001:2015 standard with extensive additions pertaining to more stringent controls applicable to such sensitive products. ISO 13485:2016 certification is commonly an initial step for medical device manufacturers seeking compliance with the requirements of the Medical Device Directive (MDD) and the CE marking process in the European Union (EU).

Small businesses may gain a number of benefits from an ISO 13485:2016 certification:

• Foundation for establishing compliance with FDA, MDD or CE requirements
• Ensure QMS practices that produce consistently safe and effective medical devices
• Helps you manage risk effectively
• Provides for the opportunity to improve QMS processes and efficiencies
• Creates opportunities to gain new business within medical device industries
• Essential controls to ensure product conformity and regulatory compliance

The new ISO 13485 emphasises risk management and risk-based decision making for processes outside the realm of product realisation. The focus is on safety and performance of medical devices and compliance with regulatory requirements.

The ISO 13485 is a stand-alone standard. It is similar in scope and intent to ISO 9001.