01
Processes as data
SOPs, work instructions, and forms live as structured process data, not disconnected PDFs.
Your ISO 13485 QMS (SOPs, forms, approvals, and audit records) held in the same data model as your technical documentation.
Complaints
QM list · Sterilizator 20A
Cycle abort during H₂O₂ run
Indicator fail after lumen load
The job
QMS and TechDoc should not live in two systems. One model keeps both audit-ready.
SOPs, work instructions, and forms live as structured process data, not disconnected PDFs.
Lists, CAPAs, and complaints stay linked to the products and documents they touch.
Approvals and audit trails run on the same governed model as technical documentation.
The complaint form is a step on the process, and the QM list is that same record. It is on the list when it is opened, tied to the product and the documents it touches. Approval and close stay on that link.
Model
ModelingComplaint Handling
Process as data — decision gates on the record
In the product
BPMN processes with roles and turtle detail, forms and QM lists, and blueprints: the QMS jobs an ISO 13485 lead runs every week.
01 Capability
SOPs and work instructions as BPMN flows. Roles, goal, scope, and turtle-model step detail live on the same process.
Complaint Handling
SOP · BPMN process
Each step links a form, template, or role — not a Word SOP.
02 Capability
Forms and records; QM lists (complaints, CAPA, and the rest) linked to product data.
Complaints
QM list · Sterilizator 20A
Auto analytics
Cycle abort during H₂O₂ run
Indicator fail after lumen load
Door seal leak — cycle abort
03 Capability
Process blueprints you adapt, plus legacy SOP upload into the structure.
Drop .docx to import
Also on this platform
Quality management sits on the same structured model as technical documentation. Guided Services help you stand it up.
Proof
Surgical monitoring device. QMS migration from legacy system to ISO 13485, completed in 6 weeks.
Next step
SOPs, lists, and approvals linked to the same product data as your technical documentation.