ISO 13485:2016 Medical Devices – Quality Management Systems

ISO 13485 certification, an international standard that defines quality management system (QMS) requirements for manufacturers of medical devices.

The primary objective of the standard is to facilitate harmonized QMS requirements for regulatory purposes within the medical device sector.

It is applicable to manufacturers of medical devices and to those organizations that support medical device manufacturers. Manufacturers have a duty to ensure that devices consistently meet customer requirements and meet all applicable regulatory requirements.

ISO 13485 sets regulatory requirements or, when specified, customer requirements for a management system for medical devices or services. The primary objective of ISO 13485 is to harmonize medical device regulatory requirements for quality management systems. The standard is specific to organizations providing medical devices or services, regardless of the type or size of the organization. Based on the ISO 9001 process approach to quality management, ISO 13485 focuses on what manufacturers must do to provide safe and effective medical devices.

Benefits with ISO 13485 certified products

  • Full documentation and traceability of production processes
  • Compliance with regulatory requirements in regard to EU, US and other national directives about medical devices (MD), in vitro Diagnostics (IVD) or medicinal products
  • ISO 13485 compliant quality management system (QMS) is in line with the Food and Drug Administration’s (FDA) QSR standards

Key requirements of ISO 13485

ISO 13485 focuses strongly on the compliance of manufactured products and production processes with EU directives for MD or IVD such as:

  • Provision of technical documentation (medical device file / technical product file)
  • Specific design & development requirements
  • Labeling, packaging and installation
  • Sterile MD / IVD
  • Implementation of a risk management process
  • Health, safety and staff hygiene requirements
  • Change management, market observations and procedures for product recall

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