ISO 13485 Medical Device QMS Mandatory Documents Kit
ISO 13485:2016 is the quality management standard required for CE marking under EU MDR/IVDR and referenced by FDA 21 CFR Part 820. This kit contains all 77 mandatory documents.
Quality Manual, Quality Policy
Template document
Quality Objectives Register
Template document
Management Representative Appointment
Template document
+ 3 more templates
Complete document set
What's included
Everything you need to build a complete compliance documentation set.
- Quality Manual, Quality Policy
- Quality Objectives Register
- Management Representative Appointment
- Organizational Chart and Responsibilities Matrix
- Customer Feedback and Satisfaction Procedure
- QMS Planning Record
- Document Control Procedure
- Record Control Procedure
- Controlled Document Register
- Document Change Request Form
- Document Review and Approval Log
- Management Review Procedure
- Management Review Agenda Template
- Management Review Minutes Template
- Management Review Input/Output Record
- Internal Audit Procedure, Programme, Checklist
- Internal Audit Report Template
- Audit Finding and Corrective Action Log
- Nonconforming Product Procedure
- Corrective Action Procedure
- Preventive Action Procedure
- CAPA Register
- Nonconformance Report Template
- Design and Development Procedure
- Design and Development Plan Template
- Design Input/Output Specifications
- Design Review Records
- Design Verification/Validation Plans and Reports
- Design Transfer Procedure, DHF Index
- Supplier Qualification Procedure
- Approved Supplier List
- Supplier Evaluation Record
- Purchasing Procedure
- Purchase Order Template
- Incoming Inspection Procedure
- Production and Process Control Procedure
- Device History Record Template
- Batch/Lot Record Template
- Equipment Calibration and Maintenance Procedure
- Calibration Log
- Infrastructure and Work Environment Procedure
- Process Validation Protocol and Report
- Post-Market Surveillance Procedure
- PMS Plan Template
- Complaint Handling Procedure and Register
- Adverse Event and Vigilance Reporting Procedure
- FSCA Procedure
- PMCF Plan Template
Is this right for you?
We believe in being upfront. Here's who this pack works best for.
- Medical device manufacturers pursuing ISO 13485 certification or CE marking under EU MDR/IVDR
- QA managers and regulatory affairs professionals building a QMS from scratch
- Startups entering the medical device market
- Companies transitioning from FDA 21 CFR Part 820 to ISO 13485 alignment
- Organizations already certified with complete QMS documentation
- Teams only needing specific QMS areas
- Those unfamiliar with ISO 13485 requirements
Why teams choose this pack
Practical benefits without the hype. Here is what you actually get.
Clarity from the start
No more staring at blank documents. Each template shows you what belongs where and why it matters.
Hours saved on structure
Skip the research phase. Start with proven layouts that align with regulatory expectations.
A path to follow
The included guides give you a practical sequence so you know what to tackle first.
Foundation to build on
These templates grow with you. Adapt them as your compliance program matures.
Questions about this product
Common questions specific to this template kit.
Ready to get started?
Skip the blank-page anxiety. Start with structure that aligns with ISO 13485 and adapt it to your context.
Instant download. Free updates. Single organization license.