The current scope of work demands highly specialized expertise across multiple regulatory and quality standards governing medical laboratories, device validation, and testing environments. These include:
ISO/IEC 17025 – Testing & Calibration Laboratories
ISO 15189 – Medical Laboratory Quality Management
ISO 13485 – Medical Devices Quality Management Systems
Regulatory frameworks (FDA, WHO, CLSI)
NABL compliance and audit readiness
Additionally, the work involves critical quality processes such as validation, CAPA, risk management, data integrity, and audit handling, which are essential to maintain compliance, accreditation, and client commitments.
Skill Gap in Internal Resources
A detailed internal capability assessment indicates that while the team possesses strong foundational knowledge in engineering and testing, there is no single internal resource (or combination) with sufficient depth and hands-on experience across the following required competencies:
End-to-end implementation and maintenance of ISO/IEC 17025, ISO 15189, and ISO 13485 QMS frameworks
Practical exposure to regulatory expectations (FDA, WHO, CLSI) in a medical laboratory setup
Proven experience in:
CAPA management and effectiveness checks
Root Cause Analysis (5 Why, Fishbone)
Risk management and deviation handling
Change control systems
Internal and external audit execution
Strong expertise in:
QMS documentation (SOPs, records, document control in audit-ready format)
Data integrity principles (ALCOA+)
Equipment qualification (IQ, OQ, PQ)
Training and competency frameworks
Laboratory-specific experience:
Process and method validation
Sample handling and traceability
Calibration and uncertainty considerations
Ability to establish and monitor:
Quality metrics and KPIs
Statistical trend analysis
