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ISO Certification and the Medical Device Industry Part 1 – An Introduction to ISO and the Benefits of Certification

November 30, 2012

International Organization for Standardization (ISO) provides International Standards that ensure products and services are consistently safe, reliable and of good quality. From a business perspective using ISO can be a strategic tool to improve the efficiency and effectiveness of company operations. They can help companies to access new international markets, level the playing field in competitive markets and facilitate free and fair global trade. ISO has over 19,000 standards touching almost all aspects of daily life.

When products and services conform to International Standards consumers can have confidence that they are safe, reliable and of good quality. For example, ISO’s standards on road safety, toy safety and secure medical packaging are just a selection of those that help make the world a safer place.

ISO develops and publishes International Standards, including management system standards such as ISO 13485 and ISO 11135. However, it is not involved in the certification to any of the standards it develops. Certification is performed by an external certification body and a certificate is issued by an Accredited Registrar.

A company may decide to seek certification for the multitude of benefits certification may provide:

  • Implementing a Quality Management System, in general, helps to motivate staff and provide a better definition of roles and key responsibilities.
  • Implementing a Quality Management System specifically tailored for the medical devices industry helps the organization to demonstrate its ability to systematically provide medical devices and services that consistently meet customer requirements, applicable regulatory requirements (compliance) and safety standards.
  • Cost savings can be made through improved efficiency and productivity, as product or service deficiencies will be highlighted and corrected.
  • Improvements can be developed on a systematic and monitored base, resulting in less waste, less inappropriate or rejected work, and fewer complaints.
  • Provides a systematic approach to risk management.
  • Systematic, smoother, transparent and documented handling of activities required by regulation such as post-marketing follow-up and surveillance, complaint handling, CAPA implementation, field actions or product recall handling, vigilance and competent authorities reporting, and clinical experience enrichment.
  • Systematic incorporation, at an early stage and within the design and development process, of the regulatory requirements impacting on the product itself and its technical features.
  • Help creating a systematic vision embracing the medical device lifecycle, medical device packaging, its labeling, its installation, its servicing, and its usability. This includes the information provided together with the medical devices, the commercial claims, the unspoken user expectations, the feedback from users or patients, the risks associated with use, the benefits brought to the single patient and to the Community, the costs and the disposal of the medical device.


In our next blog we’ll go over some of the terminology that comes into play when discussing ISO certification.

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