Most products submitted for prequalification will require one of three types of laboratory-based testing, depending on the volumes that are likely to be deployed and whether the product is safety-critical or not:

• Type-examination: An inspection of a product sample. Required for items that are not programme-critical.
• Independent type-testing: An inspection and rigorous test of a sample of the product. Required for products that are programme-critical.
• Full quality assurance: An inspection of the production site carried out against a pre-defined checklist. Required for complex programme-critical products involving site-specific design and on-site installation work.

The specific type of laboratory testing required for each product is defined in the relevant verification protocol.

All independent type-testing must be carried out by an accredited testing laboratory.

Type-examination or full quality assurance can be carried out either by an accredited laboratory or by an independent specialist appointed by PQS.

Testing work must be requested and commenced by the prospective Prequalification Holder. The different types of tests, as well as the conformity/pass criteria, are detailed in the relevant verification protocols.

Payment for testing services

Laboratory testing fees must be paid by the prospective Prequalification Holder (manufacturer or licensed reseller) of the product being tested.

Laboratory test reports

WHO has made available a laboratory test report template. This template provides a generic format that WHO-certified laboratories must use when sending test results to WHO.

Test results and other required information can be entered directly into the template.

A completed template must include the following information:

• intended purpose or function of the product being tested
• testing protocol reference number
• preliminary data (e.g. number of samples, evidence of conformity)
• testing results and conclusions about conformity with PQS standards
• relevant proof of calibration and certification.

Completed test reports should be sent to Dr Isaac Gobina (gobinai@who.int), copied to Paul Mallins (mallinsp@who.int).