ISO 13485:2016 Medical Devices

ISO 13485:2016 Medical Devices

ISO 13485 is designed for use throughout the life cycle of a medical device. It supports each stage of medical device development and operation from initial concept to production and disposal. The standard helps internal and external parties certify and validate processes which maintain the stability of quality management systems (QMS).

A QMS is a set of policies, processes, and procedures that help an organization meet stakeholder expectations. By definition, a stakeholder is any person, organization, social group, or society at large that has a stake in the business. Thus, stakeholders can be internal or external to the business. (ISO 13485). The organizational benefit of a QMS is that compliance is more easily demonstrated, risk is managed effectively, and deficient processes are improved. The result is a competitive advantage through every stage of product development and sale.

Why was ISO 13485 Revised?

Like most ISO standard revisions, the goal is to maintain relevance and adapt to evolving manufacturing environments. The rapid growth and grounding breaking technology found in medical device facilities require diligent and concurrent revisions as the landscape evolves. Likewise, maintaining cohesion with other evolving standards such as ISO 9001 or USP 800 is essential.

ISO 13485 Revisions Summary

A clear emphasis is placed on appropriate infrastructure during device production, particularly sterile medical devices and sterile barrier validation.

ISO 13485 expands cross-organization cohesion and consistency between entities along medical device supply chain:

  • Increased regulatory requirements and transparency for regulatory documentation.
  • More focus on post-market activities, including complaint handling & regulatory reporting.

It also broadens standards for 3rd party organizations that interact with the medical devices manufacturer, including:

  • Design, development or repair and maintenance of medical device
  • Supply of raw materials, components or subassemblies
  • Establishes parameters for contract manufacture, sterilization, logistics or calibration of measurement equipment
  • Importers and medical device distributors
  • Additional design and development of medical devices:
  • Maintenance of the design and development activities
  • Usability guide standards
  • Robust planning for the verification, validation, and transfer of records 
  • Harmonizes validation requirements for software applications, such as QMS software, process control software, software for monitoring and measurement of ISO particulate limits.

A full PDF of ISO 13485 is available for purchase on the ISO website.

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