Medical Device Quality Management System

Medical Device Quality Management System (MDQMS) is an specific standard for medical device industry which fulfils specific needs related to production of a particular medical device such as production control, quality management & regulatory compliances.

The objective of MDQMS i.e. ISO 13485:2016 is to facilitate harmonized and maintains medical device regulatory requirements and the requirements of the Quality management systems. Medical Equipment’s are prone to any defect which causes injury to the public health and it is very dangerous. Therefore ISO 13485:2003 certification provides and boosts a confidence and creates a credibility of the organization in the mind of the stakeholder, Directors and clients.

Accreditation Scope

UKIAF provides the accreditation to deliver the ISO 13485:2016 certificate in conformity of the

• ISO 17021-1:2015 - Conformity assessment —Requirements for bodies providing audit and certification of management systems.

Benefits Of UKIAF Accreditation

Accreditation by a recognized and respected board such as UKIAF provides independent verification that certification bodies are competent enough & comply with industry and/or international standards.

UKIAF assesses and accredits management systems of certification bodies that demonstrate competence to audit and certify organizations and conform with the international standard for certification bodies.

UKIAF accreditation provides a significant advantage to the organization, who strives to meet the regulatory requirements of international standards to improve their business process & delivery of services for the customer satisfaction.

With the help of UKIAF accreditation certification bodies are able to fosters confidence and acceptance of the certification body’s certifications by end users in the public and private sectors.