Framework
ISOISO 13485:2016
ISO 13485:2016 establishes the criteria for a quality management system specifically tailored to the medical device industry, focusing on safety and efficacy. Its primary objective is to ensure that organizations can consistently provide medical products and related services that satisfy both customer needs and applicable regulatory mandates.
Overview
Background
Maintained by the International Organization for Standardization (ISO), this document evolved from the general ISO 9001 framework to address the specific safety and documentation needs of the healthcare sector. It operates as a standalone standard that emphasizes risk management and regulatory compliance over the continuous improvement model found in general business quality standards.
Applicability
This standard applies to entities involved in any stage of a medical device's lifecycle, including design, manufacturing, distribution, and servicing. It is recognized as the benchmark for quality management in major global markets, serving as a prerequisite for regulatory approval in regions such as the European Union, Canada, and Australia.