Certification planner / ISO 13485

How do you get ISO 13485 certification?

Medical device quality management system: design, production and compliance with regulatory requirements. Answer the questions, and we'll map out the stages, timeline and documents you need to prepare for your business, with the reasoning behind each one.

6–12 monthstypical preparation time 66documents in the library 7stage

Your personal roadmap

Free · no sign-up required · about 2 minutes

Describe your main products and services, your customers and how you work in a few sentences.
E.g. metal processing, software, logistics, food production, consulting
Office, factory, warehouse, construction site — all addresses to be included in the certification scope.
Accreditation bodies and legal requirements vary by country.
Do you supply sterile products?

Your answers are processed with AI solely to prepare your roadmap.

ISO 13485 certification steps

  1. Scope and gap analysisDefine the certification scope and locations, and identify the gaps between your current practices and the standard.
  2. Leadership, policy and objectivesTop management commitment, policy, roles and measurable objectives.
  3. Risks and standard-specific analysesRisks and opportunities; depending on the standard, environmental aspects, information security risks or business impact analysis.
  4. DocumentationPrepare, approve and publish procedures, work instructions, forms and lists tailored to your business.
  5. Implementation and recordsOperate the system; build up records such as training, calibration, suppliers and corrective actions.
  6. Internal audit and management reviewAudit the system yourself, close the findings and conduct the management review.
  7. Certification auditStage 1 (documentation) and Stage 2 (implementation) audits by an accredited body, followed by the certificate.

Documents required for ISO 13485

The mandatory set from the KaliteGO library. Each one is generated as docx/xlsx, filled in with your company details.

  • DD.8Applicability and Exclusion Justification Supporting Document
  • FR.18Maintenance Tracking Form
  • FR.30Training Attendance and Evaluation Form
  • FR.41Quotation and Contract Review Form
  • FR.5Internal Audit Report
  • FR.51Risk Management Plan Form
  • FR.52Hazard Analysis and Risk Assessment Form
  • FR.53Residual Risk and Benefit-Risk Assessment Form
  • FR.54Production Batch Record (Device History Record) Form
  • FR.55Process Validation Report Form (IQ/OQ/PQ)
  • FR.56Work Environment Monitoring Form (Temperature/Humidity/Particles)
  • FR.60Lot/Serial Number Assignment Form
  • FR.62Complaint Record and Evaluation Form (Medical Device)
  • FR.63Vigilance Incident Evaluation Form
  • FR.64Field Safety Notice (FSN) Template
  • FR.65Recall Effectiveness Tracking Form
  • FR.66Post-Market Surveillance (PMS) Report Form
  • FR.67Nonconforming Product Record and Disposition Form
  • FR.69Corrective/Preventive Action Form (Medical Device)
  • FR.70Data Analysis Report Form
  • LS.1Current Documents and Revision Tracking List
  • LS.11Supplier Tracking and Evaluation List.
  • LS.14Legal and Other Requirements List
  • LS.18Measuring Equipment Inventory and Calibration Plan
  • LS.19Hazard Checklist
  • LS.20Instrument Master List
  • LS.21Distribution and Traceability Record List
  • LS.22Nonconforming Product and Rework Record List
  • LS.3External Document List
  • LS.7Corrective Action Tracking List
  • PL.1Internal Audit Plan
  • PL.11Post-Market Surveillance (PMS) Plan
  • PO.28Medical Device Quality Policy
  • PO.29Medical Device Quality Manual
  • PR.10Purchasing Procedure
  • PR.12Maintenance Procedure
  • PR.13Human Resources Procedure
  • PR.14Training and Awareness Management Procedure
  • PR.29Customer Relations and Contract Review Procedure
  • PR.3Change Management Procedure
  • PR.32Control of Monitoring and Measuring Resources (Calibration) Procedure
  • PR.37Medical Device File Procedure
  • PR.38Control of Documented Information Procedure (Medical Device)
  • PR.39Quality Management System Software Validation Procedure
  • PR.45Medical Device Risk Management Procedure
  • PR.47Production Control Procedure
  • PR.48Process Validation Procedure
  • PR.50Preservation, Storage and Shipping Procedure
  • PR.51Contamination Control Procedure
  • PR.52Product Cleanliness Procedure
  • PR.54Identification and Traceability Procedure
  • PR.55UDI and UTS (Product Tracking System) Registration Procedure
  • PR.56Feedback and Post-Market Surveillance (PMS) Procedure
  • PR.57Complaint Handling Procedure (Medical Device)
  • PR.58Vigilance and Competent Authority Reporting Procedure
  • PR.59Recall and Advisory Notice Procedure
  • PR.6Internal Audit Procedure
  • PR.60Nonconforming Product Control and Rework Procedure
  • PR.7Management Review Procedure.
  • PR.8Improvement, Nonconformity and Corrective Action Procedure
  • TL.10Equipment Maintenance and Calibration Work Instruction
  • TL.11Packaging and Labeling Work Instruction
  • TL.2Supplier Evaluation Work Instruction
  • TL.8Customer Property and Product Preservation Work Instruction
  • TL.9Production Area Work Environment and Personnel Hygiene Work Instruction
  • ŞM.01Organization Chart

Frequently asked questions

How long does ISO 13485 certification take?

For most SMEs, 6–12 months. The timeline depends on your headcount, locations and current practices. The system needs to run long enough to generate records (usually 2–3 months), followed by an internal audit, a management review and the certification body's Stage 1 and Stage 2 audits.

Which documents are required for ISO 13485?

The standard explicitly requires certain documented information: scope, policy, objectives, procedures and records. The KaliteGO library has 66 document templates for ISO 13485; the planner explains which of them your business needs, and why.

Does KaliteGO issue the certificate?

No. The certificate is issued by an accredited certification body following the audit. KaliteGO gets you ready for the audit: documents, records, internal audit and management review.

Can I prepare without a consultant?

Yes. Most small and medium-sized businesses can prepare with a guided roadmap and ready-made templates. Consultants also use KaliteGO to manage multiple clients.