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Quality Policy & Objectives
Top management's quality policy and measurable objectives — e-signed and tamper-evident.
ISO 13485 §5.3, §5.4.1 (21 CFR Part 820, QMSR)
What it does
Record top management's quality policy and the measurable quality objectives that flow from it, with owners, targets, and periodic review. The policy and objectives sit at the top of your QMS — here they're controlled records, not a poster on the wall.
How Indelio handles it
The quality policy is e-signed by top management and bound to its content hash, so it can't be quietly altered; objectives carry owners and measurable targets and are tracked to review. Everything is on the immutable, hash-chained audit trail.
Key capabilities
- ✓ E-signed, content-hashed quality policy
- ✓ Measurable objectives with owners and targets
- ✓ Periodic review tracking
- ✓ Tamper-evident on the audit trail
The whole quality system shares one audit trail.
Quality Policy & Objectives plus thirteen more modules — connected, Part 11, validation included.
Explore the rest of the suite