Objectives

The primary objective of this tender is to engage a qualified and experienced service provider to conduct an independent technical audit of the Laboratory’s Quality Management System (QMS) within the Microbiology Programme. The audit aims to assess compliance with ISO/IEC 17025:2017, SANAS accreditation requirements, and relevant technical and regulatory standards applicable to microbiology laboratory testing activities. The audit will support the PPECB in ensuring the laboratory's testing processes meet international standards and regulatory standards, thereby maintaining accreditation and quality assurance over a period of three years with an option to renew for an additional two years.

Scope

The scope encompasses a comprehensive technical audit of the Laboratory’s Microbiology Programme, including but not limited to:

• Review of the quality manual and supporting procedures
• Document and record control
• Control of non-conforming work
• Corrective and preventive actions
• Internal audits and management reviews
• Risk management processes
• Staff competency, training, and authorization records
• Equipment calibration and maintenance records
• Supplier and subcontractor management
• Method validation and verification processes
• Measurement traceability
• Handling of test items and sample management
• Data integrity and confidentiality controls

The technical evaluation includes assessment of:

• Microbiological testing methods and procedures as per SANAS F15
• Method validation and measurement uncertainty
• Environmental monitoring practices
• Media preparation and quality control
• Sterility and contamination control practices
• Proficiency testing and inter-laboratory comparisons (SANAS F176)
• Laboratory facilities and environmental conditions
• Biosafety and safety practices
• Equipment suitability, calibration, verification, and maintenance
• Competence of technical personnel in microbiological analyses
• Compliance with SANAS technical requirements specific to microbiology laboratories

The audit will be conducted in accordance with ISO/IEC 17025:2017 and SANAS standards, with deliverables including a detailed audit report within 7 to 10 working days after completion.

Technical Requirements

The technical requirements for the audit include:

• Evaluation of the laboratory’s quality manual and procedures
• Assessment of document and record control systems
• Verification of control measures for non-conforming work
• Review of corrective and preventive actions
• Assessment of internal audit and management review processes
• Evaluation of risk management practices
• Verification of staff competency, training, and authorization records
• Inspection of equipment calibration and maintenance records
• Review of supplier and subcontractor management systems
• Assessment of method validation, verification, and measurement traceability
• Evaluation of sample handling, data integrity, and confidentiality controls
• Assessment of microbiological testing methods, validation, environmental monitoring, media quality, biosafety, and safety practices
• Evaluation of proficiency testing participation and laboratory facilities

Skills Requirements

The successful service provider must demonstrate:

• Registered SANAS Technical Assessor certification for Microbiology testing laboratories
• Extensive experience in conducting technical audits of microbiology laboratories
• Proven expertise in ISO/IEC 17025:2017 compliance and SANAS accreditation standards
• Strong knowledge of microbiological testing methods, validation, and quality control
• Capability to evaluate laboratory facilities, equipment, and safety practices
• Ability to assess staff competency and training records
• Experience in managing audit documentation and producing comprehensive reports
• Based in Gauteng for the duration of the audit team members responsible for the PPECB’s audit