Who is this service for?
- Organizations building a first QMS
- Organizations restructuring an existing system
- Teams preparing for an external audit or certification
ISO 13485 · QMS
ISO 13485 Quality Management System Implementation
We connect QMS clauses to the organization’s real processes so responsibilities, records, and closure controls can operate and be reviewed.
What the review needs
- Organization and product scope
- Structure and responsibilities
- Current procedures and records
Reviewable deliverables
Scope and process map
Define scope and processes
Document and record matrix
Compare current state with requirements
QMS implementation roadmap
Build documents and record controls
Gap and readiness register
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
Before engagement
Does Basier issue ISO 13485 certificates?
No. Basier supports implementation and readiness; an independent certification body makes the certification decision.
Is one template suitable for every organization?
No. The QMS must reflect the organization’s actual scope, products, processes, and responsibilities.
Official references
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.