ISO & Quality Management

CAPA cycles, internal audits, and nonconformities that close properly

Coordinate CAPA investigations, internal audits, and corrective actions so root cause gets documented, actions get closed, and no gap survives into the next certification audit.

Create my first Flow Talk to sales

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

Register detected nonconformity46%
Quality AnalystMandatory opening
Root cause analysis (5 Whys)
Quality ManagerMandatory evidence
Corrective action plan approved
Area OwnerApproval gate
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.

Quality

CAPA, Corrective and Preventive Action

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

SituaçãoCAPA without complete cycle, external auditors issue a major nonconformity, putting certification at risk.

GanhoEach CAPA with owner per phase, deadline, and registered effectiveness evidence.

Initial value: 1 weekVer detalhes

Quality

ISO Internal Audit

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

SituaçãoAudit done on paper and digitized afterward, rework and risk of data loss.

GanhoEach process audited with findings recorded and exportable report for certification body.

Initial value: 1 weekVer detalhes

Development

Training and Competencies

Training records with confirmation per employee and participation evidence.

SituaçãoMandatory QMS training without control of who completed it and when.

GanhoAuditable training coverage by employee, role, and date.

Initial value: 1–2 weeksVer detalhes

See more quality processes

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

Quality

Nonconformity Registration

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

SituaçãoNC registered without mandatory fields, insufficient data for analysis.

GanhoEach NC with complete fields, owner, and resolution deadline.

Initial value: 1 weekVer detalhes

Management

Quality KPIs and Indicators

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

SituaçãoKPI assembled manually at month-end, delayed and error-prone.

GanhoIndicators consolidated in a recurring flow with owner per data point.

Initial value: 2 weeksVer detalhes

Supply Chain

Supplier Qualification

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

SituaçãoSupplier approved over email, internal audit cannot find evaluation record and issues an NC.

GanhoSupplier evaluation history with decision, criteria, and approver.

Initial value: 2 weeksVer 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 scenario

Reference case: CAPA for nonconformity on the production line

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

Before

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

After

Opening with mandatory severity and impact fields
Approval gate blocks plan without completed root cause analysis
Effectiveness verification with attached evidence and registered owner

Expected outcomes

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.

CAPA & NCsMedia

CAPA Cycle, Opening to Closure

14 tasks3 gates

CAPA & NCsBaixa

Nonconformity Registration

7 tasks1 gate

AuditsAlta

ISO 9001 Internal Audit

16 tasks3 gates

AuditsMedia

Process-Based Audit Plan

8 tasks2 gates

SuppliersMedia

ISO Supplier Qualification

12 tasks3 gates

SuppliersBaixa

Annual Supplier Reassessment

8 tasks2 gates

TrainingBaixa

QMS Induction Training

6 tasks1 gate

TrainingBaixa

Monthly Quality KPI Collection

9 tasks1 gate

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.

Related guides

Workflow management for compliance teams: execution that creates evidence

How compliance teams can use workflow management to turn controls into recurring runs with automatic evidence collection, and stop rebuilding audit packages from scratch every cycle.

What is an SOP? Standard operating procedures explained for operations teams

A clear definition of SOPs, how they differ from policies and checklists, and why most SOP programs fail before they're tested.

SOP vs. workflow: what's the difference and why it matters for compliance

How SOPs and workflows serve different functions, and why compliance programs that confuse the two end up with documentation that proves nothing.

How to write an SOP that actually gets followed

Why most SOPs fail before they're tested, and how to write one that gets executed, not just filed.

Digital SOP Software for Operations Leaders: What to Look For (and What to Avoid)

A buyer's guide for operations leaders evaluating digital SOP software: the five capabilities that separate a real SOP execution platform from a task manager with a checklist view, plus the one question to ask every vendor.

How to implement compliance controls with SOPs (and actually prove they ran)

Why most compliance control implementations fail before the first audit, and the implementation sequence that produces clean evidence from day one.

Document approval workflow: how to build one that generates an audit trail

Why email-based document approvals fail every compliance audit, and the four elements of an approval workflow that produces evidence an auditor can actually use.

SOP for remote teams: what changes and what doesn't

Most SOPs were written assuming everyone is in the same building. Here's what needs to change when your team executes across time zones, and what stays exactly the same.

How to measure SOP compliance: the metrics that actually matter

Most teams measure whether SOPs were completed. Almost none measure whether they were followed correctly. Here's the difference, and the four metrics that tell you whether your SOP program is working.

SOP ownership: why shared means nobody owns it

When two people own an SOP, nobody owns it. How to assign SOP ownership that produces real accountability, and what happens to compliance programs that get this wrong.

How to run a compliance audit with workflow records

What changes when audit evidence comes from workflow runs instead of email threads and spreadsheets, and how to structure the audit process to take advantage of it.

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.

Create my first Flow Talk to sales

ISO & Quality Management

CAPA cycles, internal audits, and nonconformities that close properly

Coordinate CAPA investigations, internal audits, and corrective actions so root cause gets documented, actions get closed, and no gap survives into the next certification audit.

Create my first Flow Talk to sales

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

Register detected nonconformity46%
Quality AnalystMandatory opening
Root cause analysis (5 Whys)
Quality ManagerMandatory evidence
Corrective action plan approved
Area OwnerApproval gate
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.

Quality

CAPA, Corrective and Preventive Action

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

SituaçãoCAPA without complete cycle, external auditors issue a major nonconformity, putting certification at risk.

GanhoEach CAPA with owner per phase, deadline, and registered effectiveness evidence.

Initial value: 1 weekVer detalhes

Quality

ISO Internal Audit

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

SituaçãoAudit done on paper and digitized afterward, rework and risk of data loss.

GanhoEach process audited with findings recorded and exportable report for certification body.

Initial value: 1 weekVer detalhes

Development

Training and Competencies

Training records with confirmation per employee and participation evidence.

SituaçãoMandatory QMS training without control of who completed it and when.

GanhoAuditable training coverage by employee, role, and date.

Initial value: 1–2 weeksVer detalhes

See more quality processes

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

Quality

Nonconformity Registration

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

SituaçãoNC registered without mandatory fields, insufficient data for analysis.

GanhoEach NC with complete fields, owner, and resolution deadline.

Initial value: 1 weekVer detalhes

Management

Quality KPIs and Indicators

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

SituaçãoKPI assembled manually at month-end, delayed and error-prone.

GanhoIndicators consolidated in a recurring flow with owner per data point.

Initial value: 2 weeksVer detalhes

Supply Chain

Supplier Qualification

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

SituaçãoSupplier approved over email, internal audit cannot find evaluation record and issues an NC.

GanhoSupplier evaluation history with decision, criteria, and approver.

Initial value: 2 weeksVer 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 scenario

Reference case: CAPA for nonconformity on the production line

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

Before

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

After

Opening with mandatory severity and impact fields
Approval gate blocks plan without completed root cause analysis
Effectiveness verification with attached evidence and registered owner

Expected outcomes

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.

CAPA & NCsMedia

CAPA Cycle, Opening to Closure

14 tasks3 gates

CAPA & NCsBaixa

Nonconformity Registration

7 tasks1 gate

AuditsAlta

ISO 9001 Internal Audit

16 tasks3 gates

AuditsMedia

Process-Based Audit Plan

8 tasks2 gates

SuppliersMedia

ISO Supplier Qualification

12 tasks3 gates

SuppliersBaixa

Annual Supplier Reassessment

8 tasks2 gates

TrainingBaixa

QMS Induction Training

6 tasks1 gate

TrainingBaixa

Monthly Quality KPI Collection

9 tasks1 gate

See full template library →

FAQ

Straightforward answers for implementation

Does Cadenio replace our QMS?

How do I export CAPA evidence for the certification body?

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.

Related guides

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.

Create my first Flow Talk to sales