maintenance support for mining, oil & gas and other industries with on-premises healthcare facilities.

Bioworld maintains an administrative, technical supervision and control infrastructure system for customers who require technical support from local vendors in the countries and locations they operate in due to inability to make use of ‘ISO13485 accredited” out-of-country service providers. This is especially helpful during pandemic lock-downs such as currently experienced during the Covid-19 crisis.

This program is merely a duplicate of our r-HTM service package with the difference that we qualify, vet, train and oversee local vendors for them to be able to provide the technical support services for PM, Calibration and corrective intervention requirements on site in line with our internally accredited operating procedures and operational methodology.

Bioworld trains vendors prior to their site visits on correct operational procedures, OEM and standards compliant task completions, data management and data entries on the control systems. Bioworld’s administrative team then processes all data from where our senior control engineers verify data accuracy before reports and calibration certification are extracted from the system for submission.

As part of the vetting, qualification and preparation of the vendor on behalf of the customer, Bioworld also assesses the Vendor’s test equipment, tool-sets, and skill sets for compliance. Calibration certification of test equipment are assessed for accuracy and validity and technician skill-sets are qualified to Bioworld’s internal “minimum qualification” criteria.

From this point, the local vendor and his technical representative remains in constant contact with the senior Bioworld control engineer who assists him interactively through online media on site for correct implementation of intervention specifications and associated tasks, as well as procedural aspects for correct and compliant intervention methodology, both preventive and corrective.

All intervention procedures and tasks completed by the vendor and subsequently captured by him / her. on our control system are then verified by the control engineer for correctness and absolute traceability on all tasks performed while the vendor is was on site from which an ISO13485 compliant report is generated and forwarded to the client.

All intervention history is kept on the system in a secure environment on behalf of our customers ensuring their standards driven compliance and customers are welcome to access our systems and any time for vetting and audit purposes.

Our r-HTM “Vendor” service program includes the following:

• Provision and implementation of pre configured ISO13485 and harmonised standards compliant control system for operational management of the work requirement, 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.)
• Qualification, vetting and scrutinising of vendor data, ability, skill-sets and test equipment / tools as well as suitability
• Training for and monitoring of correct implementation of operational processes and standard operating procedures associated with Planned Preventative Maintenance and calibration on all equipment required.
• Training for and monitoring of correct implementation of operational processes and standard operating procedures associated with Corrective intervention on all faulty equipment requested by the client.
• Verification of data submitted and eventual compilation and submission of standards compliant reports for traceability and audit purposes.
• Intervention data storage for historical and traceability record keeping.