General Technical Support Descriptions & Content

Healthcare Facilities - Biomedical Engineering & Technical Support

ISO13485 compliant technical support for hospitals.

Bioworld has a long history of providing cost effective managed service solutions as a 3rd party service provider to organisations across the world. Our portfolio includes managed service contracts in Afghanistan, South Africa and Lesotho.

The primary aim of our Managed Service product is to mobilise a fully compliant Biomedical / Clinical engineering / estate & facilities technical departments for both new and established healthcare facilities (Primary Acute and sub-acute hospitals) with Bioworld trained technical staff and administrators in 3rd world and developing countries. (This can also include 1st world countries where our services are needed.)

The aim is to assist customers in establishing ISO13485 and harmonised standards compliant technical support centres in the shortest timeframe possible.

Our normal approach is a 5 year plan throughout which we link with social development programs for local skill-set education, training and social upliftment towards standards compliant operations control and technical support of health technology maintenance and lifecycle / ownership management requirements.

Once compliance has been attained and the skills upliftment program of local candidates pass an in-depth quality assurance audit, the site is then handed over to the client for continuous in-house operations.

The program includes the following:

  • Provision and implementation of pre configured ISO13485 and harmonised standards compliant control system for operational management of the project, including enterprise “asset” Management (EAM), computerised maintenance management (CMMS), Process management, KPI & Reporting Management as well as traceability dashboard (Certification, Work orders and equipment migration etc.)
  • Assistance with Procurement planning and vetting of suppliers and equipment including compilation of compliant asset lists and population of the ISO13485 configured enterprise management system for use during the project (New Sites)
  • Assessment of assets and compilation of compliant asset register as well as loading of asset lists and population of the ISO13485 configured enterprise management system for use during the project. (Established sites)
  • Planned Preventative Maintenance schedule planning and technical support implementation based on GMDN information and risk based classification.
  • Day to day PPM work completion including training of qualified skill-sets on correct PPM workload execution and ISO compliant workflow principles
  • Corrective intervention prioritisation planning and technical support implementation through appropriate skill-set provision
  • Day to day corrective work completion including training of qualified skill-sets on correct corrective workload execution and ISO compliant workflow principles
  • Development of predictive maintenance indicator dashboard towards parts procurement program in mitigating downtime.
  • Periodic Key Performance analysis and reporting submissions
  • Communal skill-set isolation, training and education
  • OEM / Supplier relationship building including development of cost effective ISO compliant parts sourcing and training infrastructure schedules and programs.
  • Provision and implementation of ISO13485 and harmonised standards compliant workflow procedures (with support documentation including policies, operating procedures etc.)
  • Provision and implementation of ISO13485 and harmonised standards compliant procedural control management infrastructure (OHS, EHS, COSHH, SSOW)
  • Provision and implementation of ISO13485 and harmonised standards compliant Quality management and audit control infrastructure.
  • Regular quality audits with risk based interactive remediation program implementation.

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