Building your ISO 13485 baseline
The ISO 13485 baseline is the foundation of your quality system. XyReg drafts it from your device profile, then you review, adapt and approve.
What the baseline contains
- Quality manual and quality policy scoped to your device and role (manufacturer, importer, distributor).
- The full mandatory SOP set: document and record control, CAPA, non-conformity, management review, supplier control, training, complaint handling and vigilance.
- Design control procedures aligned to ISO 13485 clause 7.3.
- Risk management plan per ISO 14971 and a usability engineering file per IEC 62366-1.
- Forms, templates and record placeholders, pre-linked to the procedures that reference them.
A realistic timeline
Day 1: complete the device profile and generate the baseline. Day 2–3: review and adapt the drafts with your team — this is where your process knowledge goes in. Day 4: approve with electronic signatures and issue the first revision. Day 5: onboard the team and record the training.
You end the week with a released, versioned quality system rather than a folder of unapproved templates.
Document and record control
Every document has an owner, a revision history, a review cycle and an approval workflow with 21 CFR Part 11 compliant electronic signatures. Superseded revisions stay retrievable, and the audit trail is immutable.