Ongoing Quality Review and Monitoring
ZDHC Approved Solution Providers are subject to continuous performance monitoring during the approval period. Monitoring includes assessment of data accuracy, report completeness, investigations outputs, non-conformities management and responsiveness to technical enquiries.
Quality reviews also cover competency documentation, key staff qualifications, training records, authorisation controls, security measures and any other relevant documentation. Sample reviews of generated Performance InCheck Reports may be conducted to ensure traceability from supplier inventory inputs and to verify conformance accuracy.
Audit and document assessment activities
Audits may be conducted based on performance concerns, or major incidents. ZDHC also reserves the right to initiate and perform audits at any time when deemed necessary to ensure compliance, quality assurance, and programme integrity.
Audits may be performed on-site or remotely and assess quality documentation, reviewers, quality control practices, training records, and corrective action effectiveness.
Audit reports and corrective action records shall be retained for the entire duration of the Solution Provider’s approval period and for a sufficient historical window to ensure continuous data traceability and accountability."
Audit findings will be classified according to severity.
Non-conformance management
This systematic approach classifies deviations from ZDHC requirements based on their direct impact on technical validity and data integrity. It ensures that all non-conformities are identified, recorded, and resolved through mandatory Corrective Action Plans (CAP) to safeguard the programme’s credibility.
Minor non-conformity
A deviation from established procedures, documentation requirements, or operational practices that does not compromise the validity, reliability, or integrity of test results, laboratory credibility or overall compliance with ZDHC expectations.
Minor non-conformities should be addressed through appropriate corrective actions within the defined timeframe to support continual improvement of laboratory performance.
Major non-conformity
A significant failure to meet ZDHC technical, quality, or operational requirements that directly affects or has the potential to affect the credibility, accuracy, integrity or traceability of test results or laboratory operations.
Major non-conformities require immediate corrective action and resolution to prevent risk to data quality, compliance status, or the integrity of the approved laboratory system.
The quality assurance assesses the severity of the incident and determines whether additional oversight measures, audits or temporary suspension are necessary. Any incident affecting the reliability, accuracy or integrity of In-Check verification shall be formally recorded.
Major non-conformities or systemic or repeated minor non-conformities may lead to suspension.
Technical Bulletins
To support the consistent implementation of programme requirements, ZDHC may periodically issue Technical Bulletins (TB) to provide clarifications, additional guidance or updates related to specific activities, processes or technical requirements applicable to solution providers.
Technical bulletins are communicated to solution providers via email and are also made available on the Solution Provider Platform in the News section for reference and record keeping. These bulletins form part of the operational guidance supporting the implementation of ZDHC requirements and should be reviewed and applied where relevant.
Technical bulletins ensure a common understanding of requirements, promote consistent interpretation of technical criteria and support harmonised implementation across all ZDHC Approved Solution Providers.