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Supplier qualification checklist

A per-supplier working checklist covering the full qualification lifecycle.

Complere Resource Library Excel workbookSuppliersChecklist Last reviewed

Supplier findings are a perennial inspection theme: suppliers used outside their approved scope, qualifications that never got requalified, agreements that do not cover change notification. One workbook per supplier walks classification, evaluation, approval and monitoring so each decision carries its evidence.

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Supplier qualification checklist — the Excel workbook you download, showing its stages and columns

What the checklist covers

The workbook walks 13 requirements across four lifecycle stages — CLASSIFY, EVALUATE, APPROVE, MONITOR — one workbook per supplier, each row with an evidence reference, owner, date and a Complete / Open / N-A dropdown, plus an Instructions tab and a worked example row.

  • Risk classification with documented rationale and route selection
  • Evaluation evidence: certificates, questionnaires, audits, technical trials
  • Quality/technical agreement and approved-supplier-list scope
  • Performance monitoring: complaints, deviations, delivery trending
  • Requalification schedule, change notifications and disqualification path

Frequently asked questions

What does risk-proportionate supplier qualification mean?

The depth of qualification matches the impact of the supplied item on product quality and patient safety — a critical API supplier warrants an audit; a low-risk consumable may justify certificate review only. The checklist's first rows force that classification and its rationale onto the record.

Do all suppliers need an on-site audit?

No — the route (audit, questionnaire, certificate review) should follow the risk classification, and the justification for the chosen route should be documented. Unjustified questionnaire-only qualification of critical suppliers is a common finding.

What belongs in a quality agreement?

Responsibility allocation, specification and change notification duties, audit rights, and complaint/deviation communication — agreed before supply starts. The checklist treats the agreement as an approval-stage requirement, not an afterthought.

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