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
Certified WHO PQS Certification Video
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
- Directive in which product classified
- Self Certification or Compliance Certification
- Notify body 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:
Day 1
Scope defined, BIS Registration, Procedure, Selection, Cost Estimates
• Finding 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 Awareness training to QC manager and Production Manager
• Implementing a well-documented manual throughout the life cycle of the product
Week 8
Internal Audit, MRM, CAPA
• Internal audits identifying nonconformities related to WHO PQS requirements
• Management Review Meetings
• Corrective and Preventive Action plan for nonconformities
Week 10
NoBo, Audit, N-C Closing
• Shamkris acts on your behalf and assists you in the third-party audit
• Closing of any nonconformities identified by the where applicable
Week 12
Self Certification/NoBo
• WHO PQS certificates issued for 5 years (or each project)
• Surveillance Audits yearly where aaplicable
Year on Year
Yearly Compliance
• Support of Yearly documentation for audit
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.