Avensys UK Ltd are required to have both ISO 9001 and ISO 13485 accreditation by many of our medical engineering customers.

As independent proof of our continuing commitment to quality throughout the business, in support of medical device through life management. Since 2013, Avensys UK Ltd has successfully retained both certifications.

To understand more, here is a brief outline of what both mean:

ISO 9001:20008 – Quality Management Systems

The potential benefits to any organisation of implementing a quality management system based on the ISO 9001 International Standard are:

  • the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements
  • facilitating opportunities to enhance customer satisfaction
  • addressing risks and opportunities associated with its context and objectives
  • the ability to demonstrate conformity to specified quality management system requirements

ISO 13485:2012 – Medical Devices – Quality Management Systems

ISO 13485:2012 is a quality management system for medical devices specifically for regulatory purposes.

The requirements for ISO 13485 Medical Devices describe a systematic approach, within which Medical Device manufacturers and other associated bodies can identify, review and decide on the appropriate manner to incorporate regulatory requirements, other standards, and regulatory guidance documents into their quality management system.

In this context, ISO 13485 requires Medical Device manufacturers and associated bodies to provide extra quality management system elements including:

  • necessary resources
  • infrastructure and competent personnel
  • documentation and records for the operation of the quality management system
  • systems of internal audit and management review
  • systems to address nonconformity
  • corrective action and preventative action

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