The WHO Performance, Quality, and Safety (PQS) process prequalifies products and devices so that member states and UN purchasing agencies are assured of their suitability for use in immunization programs. The PQS process also encourages a wide range of manufacturers to apply for prequalification so that a competitive marketplace develops.
The WHO PQS Devices Catalogue includes details of all immunization-related products currently pre-qualifies by WHO for procurement by United Nations agencies, in addition to comprehensive guidance notes to help purchasers make informed choices. The catalog is updated whenever a change occurs with regards to a product, a manufacturer, or a laboratory.
The extent of Documented Information differs as per:
• Finding EAC TRCU standard applicable to the product
• Selecting the appropriate certification scheme
• Based on the scope of the product and certification scheme
• Technical file, Plant Master file and Test Protocol
• Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
• Review of Standard Operating Procedures (SOP)
• WHO PQS Protocol to product manager for testing & sample model preparation
• Preparation of sample & submit to the WHO PQS
• Implementing product planning & Testing
• WHO PQS will conduct testing as per their protocol & a procedure
• Queries will reply for all discrepancies
• Review of report once testing conducted by WHO PQS
• Shamkris acts on your behalf and assists you in the WH O PQS audit
• Assist on during inspection & trained the staff for inspection
• WHO PQS certificates issued & updated on their database
• Quarterly Inspection is Mandatory
• Support of Yearly documentation & compliance for documentation & Inspection for quarterly bases
• Support on any changes in product for updation on WHO PQS file
The Performance, Quality and Safety (PQS) Catalogue includes WHO prequalified products used in immunization programs such as cold chain equipment, syringes, safety boxes, temperature monitoring devices and other clod chain and logistics equipment.
A PQS is a professional quantity surveyor and this person role effectively is to stand in the client’s shoes, in terms of managing the costs and legal processes of the building project.