For beginners ISO 13485:2016 – Quality Management System

What is it?

ISO 13485:2016 is the standard that was issued by the International Organization for Standardization (ISO). Standard in which requirements are specified for a Quality Management System (QMS) for Medical Devices. It is internationally recognized. A great deal of medical companies is using compliance with this standard to achieve the certification of their QMS. In some countries, like Suadi Arabia, this global standard is mandatory.

The ISO 13485:2016 is a standalone standard. It is mainly based on the structure of ISO 9001 standard but includes some particular requirements for medical devices such as traceability, risk analysis, and sterile manufacturing.

What is it for?

Standard is designed and intended for use by organizations involved in one or more stages of the life-cycle of a medical device, including:

  • design and development,
  • production, storage, and distribution,
  • installation, servicing and final decommissioning
  • disposal of medical devices or provision of associated activities

These requirements of the standard can also be used by suppliers or other external parties providing products to such organizations. Sometimes they voluntarily choose to conform to these requirements or can be required by contract to conform. It can be used by internal and external parties, including certification bodies.

Regulatory requirements of ISO 13485:2016 are progressively stringent throughout every step of a product’s life cycle. Organizations in the medical industry are expected to prove their quality management processes and ensure the best practice in everything they do. Requirements of the standard apply to organizations regardless of their size and their type, except where explicitly stated.

All processes, required by standard ISO 13485:2016 that aren’t performed by the organization, but apply to the organization, responsible for these processes is the organization and they are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling those processes.

 For organizations that are operating in the medical device supply chain, requirements of ISO 13485:2016 standard are crucial. Certification of this standard is relevant by organizations whose services support medical device manufacturers and manufacturers that want to demonstrate applicable regulatory requirements.

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