ISO 13485 Medical Device QMS Software
Support ISO 13485 compliance with lot and serial traceability, QC hold states, AQL inspections, NCR and CAPA workflows, and versioned BOMs inside your ERP.
ISO 13485 is the international quality management system standard for medical device manufacturers, published by ISO and built on the structure of ISO 9001 with device-specific requirements for risk management, traceability, and design controls. It matters because notified bodies, the FDA, and your customers treat ISO 13485 certification as the price of entry: without it you cannot CE-mark a device in Europe, and most OEMs will not place an order with a supplier who can't show a certified QMS. WorkCell is not itself certified to ISO 13485, but its features are built to support the records and controls an ISO 13485 audit demands: lot and serial traceability with QC hold states, AQL inspection templates, NCR and CAPA workflows, and versioned BOMs and routings with effective dating that act as device-record configuration control.
Sound Familiar?
Device History Records reconstructed from paper travelers
ISO 13485 clause 7.5.1 and the FDA's Device History Record requirement mean every unit needs proof of which components, lots, and inspections went into it. When operator sign-offs live on paper travelers, component lots sit in receiving binders, and final inspection data hides in a separate spreadsheet, building one DHR for an auditor turns into a week of cross-referencing.
Traceability gaps that block a recall
When a supplier flags a bad material lot, you have hours to identify every finished device that consumed it and every customer who received one. If lot genealogy is not linked from incoming receipt through work order consumption to the lot-coded shipment, the recall turns into a guess and the auditor turns it into a finding.
CAPA backlogs and orphaned nonconformances
ISO 13485 clause 8.5 expects nonconformances to drive corrective action with root cause, containment, and effectiveness verification. When NCRs accumulate in spreadsheets with copy-pasted causes and CAPAs that never close, the next surveillance audit re-flags the same defect you wrote up two quarters ago.
Uncontrolled BOM and routing changes
A device built to a superseded BOM revision or an out-of-date process routing is a nonconformance waiting to be found. Without effective-dated, versioned BOMs and routings, purchasing buys to the old print, the shop floor runs the old process, and your as-built records no longer match the released configuration.
Core Capabilities
Lot and serial traceability for Device History Records
Every component lot and serial tracks from receiving through work order consumption to the lot-coded, serial-coded shipment. Forward and backward genealogy is one query, so the Device History Record an ISO 13485 auditor or an FDA investigator asks for assembles itself from the same records the shop floor created, instead of from a paper reconstruction project.
QC hold states and multi-location zones
Incoming, in-process, and finished material can be quarantined into QC hold states and segregated into dedicated inspection and reject zones across multiple locations. Nonconforming product is physically and systemically blocked from release, which directly supports the control-of-nonconforming-product requirements in ISO 13485 clause 8.3.
AQL inspection templates and multi-type inspections
Build AQL sampling plans and reusable inspection templates for receiving, in-process, and final inspection. Recorded measurements and pass or fail results stay linked to the lot, serial, and work order they belong to, producing the objective inspection evidence ISO 13485 clause 7.5 and 8.2 expect.
NCR severity matrix and 8-D CAPA
Nonconformances open from inspection failures, customer complaints, or supplier issues, score against a severity matrix, and escalate into 8-D corrective action with root cause, containment, and effectiveness verification. Supplier quality metrics close the loop, supporting ISO 13485 clause 8.5 corrective and preventive action.
Engineering change control through versioned BOMs and routings
Multi-level BOMs and routings are versioned and effective-dated, so released configurations are controlled and superseded revisions are retired on a known date. Work orders lock to the BOM and routing revision in effect, which gives you the design and process configuration control ISO 13485 clause 7.3 and 4.2.3 records require.
Operation-level MES and labor traceability
Hierarchical work orders capture resource, operator, and terminal data at the operation level, so every step that built a device is timestamped and attributable. Labor tickets tie back to operations, giving the process-validation and personnel-competence trail ISO 13485 clause 6 and 7.5 expect.
By The Numbers
Valid ISO 13485 certificates worldwide reported in the latest ISO Survey of certifications
ISO Survey
Year ISO 13485 was first published; the current edition is ISO 13485:2016
ISO
FDA Quality System Regulation now harmonized with ISO 13485:2016 under the Quality Management System Regulation final rule
FDA
Connected Modules
Quality
Inspections, NCRs, CAPAs, and supplier quality live as first-class records tied to the lots, serials, and work orders they govern, supplying the objective evidence an ISO 13485 audit runs on.
Inventory
Lot and serial traceability, QC hold states, and multi-location zones segregate nonconforming product and assemble the Device History Record genealogy from receiving through ship.
Engineering
Versioned, effective-dated BOMs and routings establish the controlled configuration baselines that work orders lock against, supporting ISO 13485 design and change control records.
Common Questions
What is ISO 13485?
ISO 13485 is the international standard for a quality management system specific to medical devices, published by the International Organization for Standardization. It is built on the structure of ISO 9001 but adds device-specific requirements for risk management, design controls, sterilization, traceability, and Device Master and Device History Records. The current edition is ISO 13485:2016.
Who needs to be certified to ISO 13485?
Medical device manufacturers, contract manufacturers, component and material suppliers, sterilization providers, and other organizations across the device supply chain need ISO 13485. It is effectively mandatory to CE-mark a device under the EU Medical Device Regulation, and most device OEMs require their suppliers to hold certification before placing an order.
What is the difference between ISO 13485 and ISO 9001?
ISO 13485 shares the framework of ISO 9001 but is tailored to medical devices and emphasizes regulatory compliance, risk management, and traceability over continual improvement and customer satisfaction. Certification to ISO 9001 does not satisfy ISO 13485, and the two are separate certificates, though many organizations maintain both.
How does ISO 13485 relate to FDA 21 CFR 820?
The FDA's Quality System Regulation, 21 CFR Part 820, has historically paralleled ISO 13485. Under the FDA's Quality Management System Regulation final rule, 21 CFR 820 is being harmonized to incorporate ISO 13485:2016 by reference, so a device QMS that satisfies ISO 13485 maps closely to FDA expectations for the US market.
Does using WorkCell make my company ISO 13485 certified?
No. Certification is granted to your organization by an accredited certification body after they audit your quality management system, and no software can grant it. WorkCell is not itself certified, but its features (lot and serial traceability, QC hold states, AQL inspections, NCR and CAPA workflows, and versioned BOMs and routings) are built to produce and organize the records an ISO 13485 audit requires.
What is a Device History Record and how does WorkCell support it?
A Device History Record is the documented evidence that a specific device or lot was manufactured in accordance with its Device Master Record, including component lots, process steps, and inspection results. WorkCell assembles this from lot and serial genealogy, operation-level work order data, and linked inspection records, so the DHR an auditor requests comes from the live production data instead of a paper reconstruction.
How does WorkCell help with audit readiness for ISO 13485?
Inspection records, NCRs, CAPAs, lot and serial genealogy, and BOM and routing revisions are all queryable by lot, serial, work order, part, or date range. Auditors pull objective evidence directly from the system rather than chasing spreadsheets and binders, which keeps surveillance and recertification audits focused and short.
ISO 13485 Medical Device QMS Software
Walk into your next ISO 13485 audit with the records already in order.