RakuOps is no-code process and workflow automation. Instead of managing ISO 13485 in spreadsheets and binders, you build each procedure once as a template and run it every time as a tracked checklist. Tasks get owners and due dates, forms and approvals capture the details, conditional logic and automations route the work, and every run leaves a complete, timestamped record you can attach device-quality evidence to.
Who runs ISO 13485 processes in RakuOps
How you run the ISO 13485 clauses as workflows
Every modern ISO management system follows the same Annex SL structure. Here is how you turn each requirement into a repeatable workflow in RakuOps, with a complete record of every run.
Documented information
Your SOPs and work instructions become reusable workflow templates your team actually follows on mobile, not binders nobody opens. Update the template and every future run uses the current version.
Run in RakuOpsOperational control
Run the work as tracked checklists with required tasks, forms and approvals. Every step is timestamped and attributable, and conditional logic makes sure the process runs exactly as documented every time.
Run in RakuOpsMonitoring and measurement
Capture inspections and readings with forms, then watch dashboards and reports show what was done, by whom, and when, across every run.
Run in RakuOpsInternal audit
Schedule internal audits as recurring workflow runs with structured checklists and a complete, searchable run history, so you walk into the audit with the records already in hand.
Run in RakuOpsNonconformity and corrective action
A failed check can trigger a corrective-action workflow with an owner and a due date, closed out with evidence, so findings never slip through the cracks.
Run in RakuOpsManagement review and improvement
Pull run history, dashboards and corrective-action trends leadership needs to review the system and drive continual improvement.
Run in RakuOpsWhat you can do with RakuOps
Build each procedure once as a template, then run it every time as a tracked checklist
Capture device-quality checks with forms, owners and due dates
Trigger corrective-action workflows and track them to done
Keep a complete, attributable record of every run
Every ISO 13485 process tracked to done
Your ISO 13485 procedures stop living in binders and start running as repeatable workflows. Every task has an owner and a due date, and every run leaves a complete, attributable record you can pull up whenever you need it, across every site and shift.
ISO 13485 by industry
Free ISO 13485 templates to start with
Run your ISO 13485 procedures as workflows
Build your ISO 13485 procedures once in RakuOps and run them every time as tracked checklists, across every site. Set up in under a day, no credit card required.
Start free trialFrequently asked questions
What is ISO 13485?
ISO 13485 is the international standard for quality management systems specific to medical devices. Certification is widely required by regulators and proves you consistently meet device quality and safety requirements. RakuOps is no-code process automation: you run each ISO 13485 procedure as a repeatable workflow with owners, due dates, evidence attachments and a complete run record.
How does RakuOps help you run ISO 13485 processes?
You build each procedure the standard requires (documented procedures, operational control, monitoring, internal audit and corrective action) once as a template, then run it every time as a tracked checklist. Every task has an owner and a due date, and every run leaves a timestamped record you can attach evidence to.
Does RakuOps certify my organization to ISO 13485?
No. Certification is issued by an accredited certification body after an audit. RakuOps is process and workflow automation software that lets you run your ISO 13485 procedures as repeatable workflows and keep a complete record of every run.