InspectWrk

ISO 14644 Checklist

Use this ISO 14644 checklist to review cleanroom, classification and applicable ISO 14644 parts, airborne particle cleanliness classification (part 1), monitoring for continued performance (part 2), test methods and verification (part 3), room conditions, airflow and filters, and design, construction and start-up (part 4, where applicable), scoring each item and raising corrective actions with owners and due dates.

9 sections29 questions16 to 30 minutesFree

ISO 14644Plant 2 · Cleanroom, Classification and Applicable ISO 14644 Parts0 of 3 checked
  • Record the cleanroom or controlled environment name, location and use.Wide factory floor with orange robots and control cabinets while one worker stands watchingPhoto Added
  • Record the ISO class and the occupancy state assessed (as-built, at-rest or operational).Wide factory floor with orange robots and control cabinets while one worker stands watchingPhoto Added
  • Record the editions of the applicable ISO 14644 parts and the assessment date.Wide factory floor with orange robots and control cabinets while one worker stands watchingPhoto Added
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What’s in this checklist.

9 sections · 29 questions · 16 to 30 minutes · Free

    1. Record the cleanroom or controlled environment name, location and use.

      Enter text

    2. Record the ISO class and the occupancy state assessed (as-built, at-rest or operational).

      Enter text

    3. Record which ISO 14644 parts are addressed, for example Part 1 classification, Part 2 monitoring or Part 4 design.

      Enter text

    4. Record the editions of the applicable ISO 14644 parts and the assessment date.

      Enter text

    1. Confirm the airborne-particle cleanliness classification has been determined in accordance with Part 1.

    2. Confirm the number and location of sampling points are appropriate for the cleanroom.

    3. Confirm the particle counter used is calibrated and suitable for the particle sizes assessed.

    4. Record the measured particle concentrations, the particle sizes considered, and the required ISO class.

      Enter text

    1. Confirm a monitoring plan providing evidence of continued cleanroom performance is in place.

    2. Confirm monitoring locations, frequency and alert or action responses are defined.

    3. Record the monitoring results and any alert or action responses.

      Enter text

    1. Confirm the required tests are performed using appropriate methods and calibrated equipment.

    2. Record the tests performed and their results.

      Enter text

    1. Confirm airflow, whether unidirectional or non-unidirectional as designed, and air-change performance are as specified.

    2. Confirm pressure differentials between the cleanroom and adjacent areas are maintained as specified.

    3. Confirm HEPA or ULPA filters are installed, integrity-tested and free of leaks.

    4. Record the measured airflow, air changes, pressure differentials and recovery against the specified values.

      Enter text

    1. Confirm the design, construction and start-up requirements are met where a new or modified cleanroom applies.

    2. Record the design, construction, start-up and commissioning evidence, or mark not applicable.

      Enter text

    1. Confirm operational controls, including gowning and entry and exit procedures, are defined and followed.

    2. Confirm cleaning and contamination-control practices are defined and performed.

    3. Confirm materials, equipment and personnel entering the cleanroom are controlled.

    1. Confirm monitoring results are within the required limits and trends are reviewed.

    2. Record any deviations, out-of-limit results or adverse trends.

      Enter text

    1. Record each deficiency against the applicable ISO 14644 part, with the cleanroom or location it relates to.

      Enter text

    2. Record the severity of the most significant deficiency.

    3. Record the corrective action, responsible person and target date.

      Enter text

    4. Record the overall result against the applicable requirements.

    5. Record the assessor, the evidence attached, and sign-off.

      Enter text

How the ISO 14644 checklist works.

Three steps, about 16 to 30 minutes.

  1. Work through each section

    Section by section, one check at a time.

  2. Log every finding

    Tap Fail, add a photo, assign who fixes it.

  3. Sign off and share

    The report is ready the moment you finish.

Same checklist, two ways to run it.

Paper for a one-off check. The app when every finding needs fixing.

Printed PDF

  • Pen on paper
  • Photos in your camera roll
  • Report typed up later

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  • Photos on every finding
  • Owner and due date per finding
  • Report ready at sign-off
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What is an ISO 14644 checklist?

Quick answer

An ISO 14644 checklist is the structured inspection used to assess the cleanroom against the applicable parts of ISO 14644 for its classification and continued performance that manufacturing teams use to check the key inspection points, assign owners to any failures, and close them with photo proof. Completed in InspectWrk, it is timestamped, works offline, and exports as an audit-ready manufacturing report for the applicable parts of ISO 14644 (Cleanrooms and associated controlled environments), in their current editions and the cleanroom's specified classification and operational requirements.

An ISO 14644 checklist is the structured inspection used to assess the cleanroom against the applicable parts of ISO 14644 for its classification and continued performance that manufacturing teams use to check cleanroom, classification and applicable ISO 14644 parts, airborne particle cleanliness classification (part 1), monitoring for continued performance (part 2), test methods and verification (part 3), room conditions, airflow and filters, and design, construction and start-up (part 4, where applicable), capture photo evidence, and track corrective actions to closure. Its job is to assess the cleanroom against the applicable parts of ISO 14644 for its classification and continued performance.

Why are ISO 14644 inspections still chased on WhatsApp?

Cleanroom qualification and monitoring specialists and QA and validation teams still miss unverified defects and repeat findings when rounds are ticked without photo evidence per finding.

Without a single inspection record, teams reconstruct the evidence from phones instead of proving the applicable parts of ISO 14644 (Cleanrooms and associated controlled environments), in their current editions and the cleanroom's specified classification and operational requirements readiness.

Before and After InspectWrk

Before InspectWrk

  • Line and machine inspection logs sit in Excel files on individual desktops.
  • ISO checks are ticked on paper without photo evidence per finding.
  • Non-conformances surface during the ISO 9001 audit, not when the deviation actually happened.

After InspectWrk

  • Cleanroom qualification and monitoring specialists complete the inspection in the app with photo evidence at the ISO 14644, even offline.
  • Managers see open findings, closure status, and the applicable parts of ISO 14644 (Cleanrooms and associated controlled environments), in their current editions and the cleanroom's specified classification and operational requirements evidence live on one dashboard.
  • Recurring shopfloor defects flag automatically so root cause is fixed before the next batch fails.

Why is an ISO 14644 checklist important?

It helps cleanroom qualification and monitoring specialists and supervisors keep manufacturing work consistent, safe, and auditable, with the evidence needed for the applicable parts of ISO 14644 (Cleanrooms and associated controlled environments), in their current editions and the cleanroom's specified classification and operational requirements:

  • Cover the full inspection: structured checks across cleanroom, classification and applicable ISO 14644 parts, airborne particle cleanliness classification (part 1), monitoring for continued performance (part 2), and test methods and verification (part 3) surface unverified defects and repeat findings before they reach handover, audit, or the next shift.
  • Document manufacturing findings with the right proof: capture photo evidence per finding on every issue so nothing rests on memory.
  • Stop repeat manufacturing findings: assign the fix, set a deadline, and escalate overdue actions before the next round comes around.
  • Stay audit-ready: keep one timestamped record for the applicable parts of ISO 14644 (Cleanrooms and associated controlled environments), in their current editions and the cleanroom's specified classification and operational requirements you can export instead of rebuilding it from scattered photos and spreadsheets.

What should be included in an ISO 14644 checklist?

A complete ISO 14644 checklist works through cleanroom, classification and applicable ISO 14644 parts, airborne particle cleanliness classification (part 1), monitoring for continued performance (part 2), test methods and verification (part 3), room conditions, airflow and filters, and design, construction and start-up (part 4, where applicable), then records inspection context, scored checkpoints, and evidence with corrective actions:

Inspection context

Record where and when the inspection runs:

  • Site, manufacturing location, and asset identification
  • Inspector, date, and the manufacturing areas or assets in scope
  • Reference numbers or schedules linked to the checklist

Checkpoints and scoring

Define what each checkpoint verifies and how results are scored:

  • Cleanroom, Classification and Applicable ISO 14644 Parts
  • Airborne Particle Cleanliness Classification (Part 1)
  • Monitoring for Continued Performance (Part 2)
  • Test Methods and Verification (Part 3)
  • Room Conditions, Airflow and Filters
  • Design, Construction and Start-Up (Part 4, Where Applicable)
  • 20 fields aligned to the checklist

Evidence and corrective actions

Make every finding traceable and actionable:

  • Capture photo evidence per finding on failed or critical items
  • Corrective actions with owners and due dates for manufacturing teams
  • Sign-off, completion status, and follow-up notes

How do teams use an ISO 14644 checklist?

Follow these steps to run the ISO 14644 checklist:

  1. Fill in the ISO 14644 header: inspector, site, date, and areas in scope.
  2. Work through cleanroom, classification and applicable ISO 14644 parts, airborne particle cleanliness classification (part 1), monitoring for continued performance (part 2), test methods and verification (part 3), room conditions, airflow and filters, and design, construction and start-up (part 4, where applicable) in order, recording pass, fail, or N/A.
  3. Attach photo evidence per finding wherever a failure or observation needs proof.
  4. Raise actions for unverified defects and repeat findings with owners and deadlines before sign-off.
  5. Review the ISO 14644 summary, share the report, and keep the record for your audit trail.

See how this checklist fits into Manufacturing inspection software.

This checklist runs as a mobile inspection app that works fully offline on site, with AI-powered defect detection on every photo. To see it on your own workflows, talk to our team.

AI-Powered Features for Your Field Workflows

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01 / 05Photo to formVISION AI

Take a Photo. AI Fills the Form.

Your inspector takes a photo of any asset or defect. AI reads it and fills the inspection form automatically.

No typing. No manual entry.

02 / 05Voice to textVOICE AI

Speak. AI Writes It Down.

Inspectors speak their observations in any language. AI transcribes and fills the form in real time.

Completely hands-free in the field.

03 / 05Auto reportsREPORT AI

AI Writes the Report. PDF and Excel, Instantly.

The moment an inspection is submitted, AI summarises the findings and builds a branded PDF report and an Excel sheet for you.

No manual reporting. No copy-paste.

04 / 05IntegrationsINTEGRATIONS

Connect Your Existing Tools.

InspectWrk integrates with the tools your team already uses, including Zoho, Microsoft 365, and SAP.

No double entry.

05 / 05Live dashboardLIVE DATA

Live Dashboard. Every Site. Always On.

Your operations team sees completion rates, open issues, and compliance scores across all sites in real time.

No chasing updates.

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  • Collaborate

    Collaborate with your team anytime, anywhere

    See which checklists your team has in progress across every site, jump into the same inspection with one tap, and keep field, supervisor, and back-office views in sync without sending screenshots on WhatsApp.

    • Organise inspection data by site, team, and date
    • Assign checks to the inspector or vendor responsible
    • Track completion across every location in one view
    • Keep field and back-office in sync in real time
    • Comment on findings without leaving the inspection
  • Custom Reports

    Custom reports that guide your decision making

    Every team reports differently. Build the report your operations, quality, or compliance leads actually want to read, share it as a branded PDF, and schedule delivery to the stakeholders who need it.

    • Branded PDF and CSV export from any completed inspection
    • Schedule weekly or monthly delivery to managers and clients
    • Share to email, Drive, Teams, or Slack in one click
    • Filter findings by site, severity, or corrective-action status
  • Powerful Analytics

    Analyse your inspection data with confidence

    See completion, pass rate, and recurring findings across every checklist and every site, without pulling spreadsheets together at the end of the month.

    Powerful dashboard
    Combine multiple reports into one dashboard so you can monitor status, bottlenecks, and completion trends at a glance.
    Always in sync
    Changes sync across devices so inspectors, supervisors, and back-office teams always see the latest responses and attachments.
    Embedded analytics
    Explore checklist data with charts and breakdowns that stay tied to the underlying inspections, without exporting to spreadsheets.

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It is scoped to the scheduled cadence and controls that cleanroom qualification and monitoring specialists, QA and validation teams run, not a one-off handover walk. It prompts cleanroom, classification and applicable ISO 14644 parts, airborne particle cleanliness classification (part 1), monitoring for continued performance (part 2), test methods and verification (part 3), room conditions, airflow and filters, and design, construction and start-up (part 4, where applicable), watching for unverified defects and repeat findings, records pass, fail, or N/A with photo evidence per finding on critical items, and raises corrective actions with owners before sign-off. Run in InspectWrk, the record is timestamped and rolls into trend reports so repeat failures surface before the next audit.

They work through each checkpoint to assess the cleanroom against the applicable parts of ISO 14644 for its classification and continued performance, confirm the required controls are in place, and capture photo evidence per finding on anything that fails or needs proof. Priority failure modes include unverified defects and repeat findings. Each checkpoint takes pass, fail, or N/A, and a failed item stays open until the fix is verified.

It expects photo evidence per finding on failed or critical items, so findings rest on proof rather than memory. Records support the applicable parts of ISO 14644 (Cleanrooms and associated controlled environments), in their current editions and the cleanroom's specified classification and operational requirements, and every photo, note, and sign-off stays attached to the inspection instead of living in chat threads.

The ISO 14644 checklist covers cleanroom, classification and applicable ISO 14644 parts, airborne particle cleanliness classification (part 1), monitoring for continued performance (part 2), test methods and verification (part 3), room conditions, airflow and filters, and design, construction and start-up (part 4, where applicable). On each checkpoint, cleanroom qualification and monitoring specialists record pass, fail, or N/A, add a photo on anything that needs proof, and raise a corrective action with an owner and due date. Run in InspectWrk, the inspection is timestamped, traceable to whoever completed it, and exports as a single manufacturing report aligned to the applicable parts of ISO 14644 (Cleanrooms and associated controlled environments), in their current editions and the cleanroom's specified classification and operational requirements.

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