WHO PQS CERTIFICATION
What is WHO PQS?
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.
Benefits of WHO PQS Certification
Sustainable supply chain
Cost-Effective
Confidence
Growth in business
Enhance Sustainable Growth
Global feed safety management system
Who can be certified WHO PQS Certification?
Cold rooms
freezer rooms
Refrigerated vehicles
Refrigerators and freezers
Cold boxes and vaccine carriers
Coolant-packs
Temperature monitoring devices
Cold chain accessories
Injection devices for immunization
Waste management equipment
Injection devices for therapeutic purposes
Document required for WHO PQS Certification
- Technical File, Product Master File (TCF)
- Product Testing
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Plant Master File
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Product and it's uses
- Testing requirement of products
- Standard in which product classified
- Continue Manufacturing Certificate or Project Specific Certificate
Role of Shamkris and Process of WHO PQS Certification
Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives.
The implementation process is described below:
Time Frame
Task
Process
Day 1
Scope defined
WHO PQS Certificate
Selection
Cost Estimates
- Finding WHO PQS standard applicable to the product
- Selecting the appropriate certification scheme
- Based on the scope of the product and certification scheme
Week 1
Developing Documents
- Technical file, Plant Master file and Test Protocol
- Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
- Review of Standard Operating Procedures (SOP)
Week 4
Implementing Product Management System
- WHO PQS Protocol to product manager for testing & sample model preparation
- Preparation of sample & submit to the WHO PQS
- Implementing product planning & Testing
Week 8-12
WHO PQS 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
Week 12-14
WHO PQS Inspection
- Shamkris acts on your behalf and assists you in the WH O PQS audit
- Assist on during inspection & trained the staff for inspection
Week 14-16
WHO PQS Certification Granted
- WHO PQS certificates issued & updated on their database
- Quarterly Inspection is Mandatory
Year on Year
Yearly Compliance
- Support of Yearly documentation & compliance for documentation & Inspection for quarterly bases
- Support on any changes in product for updation on WHO PQS file