DOHA: The Hamad Medical Corporation recently hosted a presentation on the benefits of International Standard Organisation certification in health care, conducted by a team from UK-based BSI Management System.
BSI is a global business services company that helps organisations to improve and protect the resilience of their businesses by providing them with independent assessment and certification of management systems against proven industry best practices, together with training services that help mitigate risk from day-to-day operations.
The event comes as HMC prepares for JCI re-accreditation, underscoring the "need to start planning future accreditations that will build towards health care excellence," according to Hanan Al Kuwari, HMC Managing Director.
The BSI team discussed extensively the current status of the ISO 9000 series and management systems standards, the description of ISO 9001 and management systems and their applicability to health care, and ISO 13485 and medical devices and their applicability to health care. This was followed by an overview of the broader benefits and use of ISO 13485 within specific departments in HMC, and the assessment and registration process benefits.
ISO 13485 requires mandatory procedures and records to control quality management systems (QMS), with an emphasis on documentation, maintenance of QMS and regulatory compliance.
The lecture also tackled the role of the Global Harmonisation Task Force (GHTF) in minimising regulatory barriers, facilitating trade and improving access to new technologies, through encouraging a convergence in standards and regulatory practices related to the safety performance and quality of medical devices. The team discussed methods of overcoming weaknesses posed by countries without a functioning regulatory system.
An open forum followed each segment of the lecture, where questions from the audience were answered by the team. It ended with a discussion of HMC's journey from implementation to certification of ISO 9001-2008.
BSI is a leading, world-class, EU-notified certification body that works with 80 percent of the world's major manufacturers of medical devices.
© The Peninsula 2009
