CADENIO

ISO & Quality Management

Quality control cycles with CAPA execution accountability

Coordinate CAPA investigations, internal audits, and corrective actions with clear ownership and audit-ready quality evidence.

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No IT required. Quality templates ready to launch in hours.

ISO 9001:2015ISO 14001:2015ISO 45001:2018Traceable CAPACertification-ready

CAPA #NC-0147

0/4 concluídas12% completo
  1. Register detected nonconformity46%
    Quality AnalystMandatory opening
  2. Root cause analysis (5 Whys)
    Quality ManagerMandatory evidence
  3. Corrective action plan approved
    Area OwnerApproval gate
  4. Action effectiveness verificationBLOQUEADA
    Internal AuditorActive auditDep. pendente

Step 1 · Priority processes

Start with the 3 processes with highest evidence requirements

CAPAs, internal audits, and training are the most scrutinized in certifications. Then expand to NCs, KPIs, and suppliers.

CAPA — Corrective and Preventive Action

Complete cycle: opening, root cause analysis, plan, approval, and effectiveness verification.

QualityInitial value: 1 week
  • Situação: CAPA without complete cycle — external auditors issue a major nonconformity, putting certification at risk.
  • Ganho: Each CAPA with owner per phase, deadline, and registered effectiveness evidence.
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ISO Internal Audit

Audit plan with process checklist, documented findings, and automatic report.

QualityInitial value: 1 week
  • Situação: Audit done on paper and digitized afterward — rework and risk of data loss.
  • Ganho: Each process audited with findings recorded and exportable report for certification body.
Ver detalhes

Training and Competencies

Training records with confirmation per employee and participation evidence.

DevelopmentInitial value: 1–2 weeks
  • Situação: Mandatory QMS training without control of who completed it and when.
  • Ganho: Auditable training coverage by employee, role, and date.
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See more quality processes

Additional flows for a complete QMS after stabilizing the highest-impact certification processes.

Nonconformity Registration

Standardized NC opening with type, severity, and responsible area.

QualityInitial value: 1 week
  • Situação: NC registered without mandatory fields — insufficient data for analysis.
  • Ganho: Each NC with complete fields, owner, and resolution deadline.
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Quality KPIs and Indicators

Recurring indicator collection by area with approval and export for management review.

ManagementInitial value: 2 weeks
  • Situação: KPI assembled manually at month-end — delayed and error-prone.
  • Ganho: Indicators consolidated in a recurring flow with owner per data point.
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Supplier Qualification

Periodic supplier evaluation with checklist, scoring, and tiered approval.

Supply ChainInitial value: 2 weeks
  • Situação: Supplier approved over email — internal audit cannot find evaluation record and issues an NC.
  • Ganho: Supplier evaluation history with decision, criteria, and approver.
Ver detalhes
Map full QMS with a specialist

Regulatory Framework

Quality processes aligned with ISO 9001, ISO 14001, ISO 45001, and CAPA frameworks

Cadenio doesn't replace your QMS — it ensures that procedures are executed according to it, with evidence ready for certification bodies.

ISO 9001:2015

Quality Management System

CAPAs, nonconformities, and internal audits executed with step-by-step checklists, ownership per phase, and exportable evidence ready for certification bodies.

ISO 14001:2015

Environmental Management

Environmental control procedures with mandatory evidence, tiered approval, and export-ready documentation for environmental certification audits.

ISO 45001:2018

Occupational Health and Safety

Safety inspections, incident investigations, and training with execution trail and digital sign-off per responsible person.

CAPA / FDA 21 CFR

Corrective and Preventive Action

Complete CAPA cycle documented: opening, root cause analysis, corrective action plan, deadline, and effectiveness verification with auditable evidence.

Step 2 · Proof of operation

Before and after in a real CAPA cycle

CAPA example with opening, root cause, corrective plan, and effectiveness verification — ready for certification.

Reference case: CAPA for nonconformity on the production line

Flow with Quality Analyst, Area Owner, Quality Manager, and Internal Auditor.

Antes

  • CAPA opened in a spreadsheet with no deadline and no root cause field
  • Action plan approved by email — no versioning
  • Effectiveness verification done verbally — no evidence recorded, CAPA flagged as incomplete in audit

Depois

  • Opening with mandatory severity and impact fields
  • Approval gate blocks plan without completed root cause analysis
  • Effectiveness verification with attached evidence and registered owner
Average CAPA cycle time reduced by 68%Zero CAPAs without root cause in auditExportable report in 1 click for certification body

Step 3 · Scale by quality process

Ready-to-run templates for a complete QMS

Start with CAPA or internal audit, then expand to cover all certification requirements.

Filter by process

CAPA & NCsAuditsSuppliersTraining

CAPA & NCs

2 templates

CAPA Cycle — Opening to Closure

Quality14 tarefas3 gatesComplexidade Media

Nonconformity Registration

Quality7 tarefas1 gatesComplexidade Baixa

Audits

2 templates

ISO 9001 Internal Audit

Audit16 tarefas3 gatesComplexidade Alta

Process-Based Audit Plan

Audit8 tarefas2 gatesComplexidade Media

Suppliers

2 templates

ISO Supplier Qualification

Supply Chain12 tarefas3 gatesComplexidade Media

Annual Supplier Reassessment

Supply Chain8 tarefas2 gatesComplexidade Baixa

Training

2 templates

QMS Induction Training

Training6 tarefas1 gatesComplexidade Baixa

Monthly Quality KPI Collection

Indicators9 tarefas1 gatesComplexidade Baixa
See full template library →

FAQ

Straightforward answers for implementation

Does Cadenio replace our QMS?

No. Cadenio acts as the execution layer — where your QMS records the procedure, Cadenio ensures it is followed step by step, with an owner and evidence at each stage. It works alongside your existing QMS.

How do I export CAPA evidence for the certification body?

Each executed CAPA generates an exportable PDF or CSV report with the full log: who opened it, who analyzed it, which corrective plan was approved, who verified effectiveness and when. Ready for ISO certification without rework.

Can I track all nonconformities over a period?

Yes. Each NC flow runs as a record with owner, date, and status. You can filter by area, type, or period — and export the complete history for trend analysis or audit reports.

Does it work for internal audits with multiple auditors?

Yes. Distribute audit steps across auditors with individual deadlines. Each finding is recorded with evidence. The consolidated report is auto-generated at the end of the flow.

How do I manage mandatory QMS training?

Create a training flow with confirmation per employee and evidence attachment (attendance list, certificate). History is traceable by person for auditable coverage in any inspection.

Your QMS deserves processes executed with evidence, not just documented

An ISO certification isn't lost overnight — it's lost through incomplete evidence. Start with CAPAs or internal audits and expand to the full QMS.

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