An ISO 13485 operating roadmap for a medical-device distributor
A work case on connecting importer and distributor operations to controlled QMS documents and records.
Company and brand names are withheld to protect engagement confidentiality.
Device or product type
A general medical-device portfolio handled through importing and distribution operations.
Challenge
Procedures were disconnected from process ownership and operating evidence, obscuring priorities and proof of implementation.
Basier’s work
Basier reviewed QMS scope, processes, ownership, documents, and records, then prioritized gaps by risk and dependency.
Output
A process map, document matrix, gap register, and closure plan.
What the engagement covered
- QMS scope and roles
- Process ownership
- Documents and records
- Closure priority
What the case shows
An operable QMS connects each requirement to an owner, record, and closure evidence—not a procedure count.
The case makes no claim of a formal audit, certification, or certification-body outcome.