ISO 13485:2016

ISO 13485:2016: Quality Management System for Medical Laboratory Equipment Manufacturing Organization. This ISO standard is for Medical Laboratory Equipment Manufacturing Organization gives assurance of international Quality Management System.

Meaning of ISO 13485:2016 (in detail): Here ISO meaning: International Organization for Standardization, 13485 means: family introduction name of ISO series for Medical Equipment Quality Management System and 2016: Publishing Year of standards. (ISO 13485:2016).

Documents are required for ISO 13485:2016 Registration
There are different types of documents are required for different types of organization please feel free to contact us any time for free ISO Consultancy or know documents are required for ISO 13485:2016 Registration.

Benefits of ISO 13485:2016

  •     Increase the credibility – This Standard increase your company’s credibility and commitment to quality.
  •     Improved performance – Due to process control, your company’s certified management system helps you improve your products.
  •     Expanded market access – National and International market access easily.
  •     Improved performance – As your organization interact with this international standard; this action improved your over performance.