Who is this service for?
- Organizations building a first QMS
- Organizations restructuring an existing system
- Teams preparing for an external audit or certification
QUALITY PILLAR
Medical Device QMS and ISO 13485 Readiness
We build the system around the organization’s real processes and turn requirements into responsibilities, documents, records, and closure controls.
01EVIDENCE LAYER
Process map and QMS scope02EVIDENCE LAYER
Procedure and record matrix03EVIDENCE LAYER
Gap assessment and closure plan04EVIDENCE LAYER
Audit-readiness packageWhat this work does not claim
- Basier is not a certification body
- No certification-decision guarantee
- This release does not offer training or internal audit as standalone services
One pillar, distinct entry points
ISO 13485 QMS implementation
Define scope, processes, documents, and records required for operation.
Service details ↗Gap assessment and audit readiness
Test readiness and build a closure plan without issuing or guaranteeing certification.
Reviewable, closure-ready outputs
01 · Process map and QMS scope
Define scope and processes
02 · Procedure and record matrix
Compare current state with requirements
03 · Gap assessment and closure plan
Build documents and record controls
04 · Audit-readiness package
Test readiness and close gaps
QMS and ISO 13485
Read the work caseAn ISO 13485 operating roadmap for a medical-device distributor
A work case on connecting importer and distributor operations to controlled QMS documents and records.
Context for the decision
Official, verifiable reference points
Sources describe the general framework. Current versions and case-specific requirements must be checked before a regulatory or commercial decision.
NEXT STEP
Request a QMS gap assessment
Sources describe the general framework. Current versions and case-specific requirements must be checked before a regulatory or commercial decision.