Guides/The notified body workspace

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The notified body workspace

How a notified body runs its certification work in MoniDoseQMS: engagements and quotes, audits and findings, certificates and EUDAMED, and the competence of its team.

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How a notified body runs its certification work in MoniDoseQMS: engagements and quotes, audits and findings, certificates and EUDAMED, and the competence of its team. For notified bodies: engagements, audits, findings, certificates and competence.

What you'll see

1
The notified body's workspace: requests to decide, active assessments and what needs attention.
2
Quotation requests from manufacturers: price the work and send the quote.
3
Each engagement has its own page, and a Next step banner shows what is due.
4
Assign a competent team and an independent decision-maker, and request access to the files you need.
5
Plan stage 1, stage 2 and surveillance audits with sites and man-days.
6
Raise findings and review the manufacturer's responses.
7
Working papers: the checklist by clause, with findings linked.
8
The audit report is generated from the audit record.
9
Certificates are signed by the decision-maker and carry a verification link.
10
The EUDAMED register keeps certificate status in step.
11
The audit calendar shows surveillance and recertification dates.
12
Our Team: auditors, reviewers and decision-makers, with their competence per scope code.
13
Complaints and appeals are acknowledged and resolved within set time limits.

The screens show sample data for fictional companies. Captions are on screen and available as a CC track.

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See how MoniDoseQMS handles this

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