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ISO 13485 · Medical device QMS

Traceability that holds from design file to complaint.

Design and development records, supplier evaluation, production controls, CAPA and complaint handling — linked so a notified body can walk from a device history record back to the design input that shaped it.

Document control and design records in Teammate App

TEAMMATE

Completing a production check on the Teammate App mobile app
ISO 13485 — Medical Devices

The QMS is judged on what you can retrieve, not what you wrote.

Notified bodies pull a thread: one complaint, back through the CAPA, the batch record, the supplier, the training and the design file. Every place that trail lives in a different system is a place it breaks.

Documents behave like records

Version history, approval, distribution and obsolete control — with the current revision the easiest one to find.

CAPA closes with evidence

Investigation, action, verification of effectiveness, and the check that the fix did not create a new problem.

Complaints connect to everything

A complaint links to the batch, the device, the supplier and the CAPA it raised, in one record.

Clause map

Where each clause actually lives.

Not a feature list — the modules your auditor will end up opening, clause by clause.

Clause register · ISO 13485:2016

Hover a clause to open it

1–3Reference terms3 parts
4Quality management system5 parts
5Management responsibility6 parts
6Resource management4 parts
7Product realization7 parts
8Measurement, analysis and improvement7 parts

Clause 1–3

Reference terms

The three opening clauses set what the standard covers and the language the rest of it is written in. Nothing is recorded against them.

1Scope — organisations across the medical device life cycle
2Normative references
3Terms and definitions

How Teammate assists

The whole platformTeammate supports the implementation and ongoing maintenance of the standard, and sits underneath it as the place every record required by the clauses is captured and kept.
Built by practitionersConfigured by people who ran management systems before they built software, so the structure follows the standard rather than a generic form builder.

Nothing to evidence here — this clause sets the terms the rest of the standard is written in.

Clause 4

Quality management system

The system, its documentation and the device file behind it.

4.1General requirements, including software validation
4.2.1Documentation requirements — general
4.2.3Medical device file
4.2.4Control of documents
4.2.5Control of records

How Teammate assists

Document ManagementDevice file structure, approvals and full version history.
Reports & ChartsRecord completeness visible before an inspection.
Task ManagementDocument review and approval tracked to a date.

Nothing to evidence here — this clause sets the terms the rest of the standard is written in.

Clause 5

Management responsibility

Commitment, policy, planning and management review.

5.1Management commitment
5.2Customer focus
5.3Quality policy
5.4Planning and quality objectives
5.5Responsibility, authority and communication
5.6Management review

How Teammate assists

NoticeboardPolicy issued and acknowledged by every worker.
Human ResourcesResponsibilities and authorities held per role.
Reports & ChartsReview inputs assembled from live data.
Task ManagementReview outputs as owned, dated actions.

Nothing to evidence here — this clause sets the terms the rest of the standard is written in.

Clause 6

Resource management

Competence, infrastructure and the work environment.

6.1Provision of resources
6.2Human resources, competence and training effectiveness
6.3Infrastructure
6.4Work environment and contamination control

How Teammate assists

Human ResourcesTraining with effectiveness recorded, not just attendance.
AssetsEquipment maintenance, validation and calibration history.
Online FormsCleanroom, gowning and environmental monitoring records.

Nothing to evidence here — this clause sets the terms the rest of the standard is written in.

Clause 7

Product realization

Design, purchasing, production, traceability and measurement.

7.1Planning of product realisation and risk management
7.2Customer-related processes
7.3Design and development
7.4Purchasing and supplier evaluation
7.5Production and service provision, cleanliness and validation
7.5.9Traceability
7.6Control of monitoring and measuring equipment

How Teammate assists

Document ManagementDesign records and device master record, controlled.
External PartiesSupplier evaluation, approval and re-evaluation on schedule.
Online FormsProduction and device history records completed in line.
AssetsCalibration of measuring equipment with certificates.

Nothing to evidence here — this clause sets the terms the rest of the standard is written in.

Clause 8

Measurement, analysis and improvement

Feedback, complaints, audit, CAPA and reporting.

8.2.1Feedback
8.2.2Complaint handling
8.2.3Reporting to regulatory authorities
8.2.4Internal audit
8.3Control of nonconforming product
8.4Analysis of data
8.5Improvement and CAPA

How Teammate assists

Online FormsComplaints and feedback captured against the device.
Task ManagementCAPA with root cause, action and effectiveness check.
Audit InspectionInternal audit programme with findings raised as actions.
Reports & ChartsData analysis for the review and the regulator.

Nothing to evidence here — this clause sets the terms the rest of the standard is written in.

Clause references are to ISO 13485:2016. Regulatory requirements — including EU MDR, FDA 21 CFR Part 820 and the requirements of your own market — sit alongside the standard and are not covered by this map. Teammate App is not a validated system out of the box; where you rely on it for records subject to computerised system validation, that validation is yours to perform. Your notified body and regulator have the final say.

Getting there

Whether you’re certifying or maintaining.

Going for certification

We configure document control, design records and supplier evaluation with you, and get CAPA and complaint handling running before the stage 1 audit so there is history to sample.

  • Document control with revision history
  • Design and development records structured to 7.3
  • Supplier evaluation and re-evaluation schedule

Already certified

Surveillance and unannounced audits stop being a scramble, because the trail from complaint to CAPA to batch to supplier was assembled as it happened.

  • Migrate your existing controlled documents
  • Complaints and non-conformance raise CAPA directly
  • Run 13485 alongside 9001 in one system

The other standards

45001

Health & Safety

Hazards, incidents, participation and worker safety.

9001

Quality

Document control, non-conformance and management review.

14001

Environmental

Aspects and impacts, obligations, monitoring and reporting.

27001

Information Security

The standard Teammate itself is certified against.

17025

Labs

Calibration, method validation and analyst competence.

Bring one complaint and we’ll follow the thread.

We’ll rebuild it live on the call and follow the thread from the complaint back through the device history record to the design file.

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