Areas to review
Scope and process interaction
Define the QMS scope, justified exclusions, process owners, inputs, outputs, performance indicators and interactions.
Document and record control
Ensure current documents are approved and accessible, obsolete versions are controlled, and records remain complete, legible and retrievable.
Management responsibility and competence
Review measurable quality objectives, management-review inputs, role-specific competence requirements, training records and effectiveness checks.
Supplier, production and design controls
Confirm risk-based supplier controls, process validations, traceability and—where applicable—complete design and development records.
Complaints, vigilance, CAPA and audits
Verify timely complaint assessment, reportability decisions, root-cause analysis, effectiveness checks and closure of internal-audit findings.
Audit rehearsal: Trace one device record end-to-end—from purchasing and release through complaints, CAPA, design and risk management.
Official source
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We provide gap assessments, internal audits and action planning.
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