Description
Product Description
This is the most comprehensive ISO 13485:2016 toolkit currently available.
The ISO 13485 Toolkit is designed in Microsoft Office format (Word and Excel) and can be customized to meet your organization’s unique requirements. Along with a standard format and content, the template documents feature sample text that is distinctly marked to show the kind of information that your organization needs to provide. Completed example entries and ready-to-use registers are also included to assist you with implementation.
Authored by experienced auditors with over two decades in Quality Management, our toolkit distills a wealth of expertise into a user-friendly format.
With quality and quantity included, this toolkit covers everything an organization needs, so you can use it first to become certified to the standard, and then to develop and continually maintain the effectiveness of your Medical Devices Quality Management System.
Built to the current standard and the latest regulations
This edition is fully aligned with ISO 13485:2016 (the current published edition) and cross-referenced to:
- FDA QMSR — 21 CFR Part 820, effective 2 February 2026 (which incorporates ISO 13485:2016 by reference and replaces the legacy QSR), including UDI (21 CFR 830) and Medical Device Reporting (21 CFR 803).
- EU MDR 2017/745 and EU IVDR 2017/746 (clinical evaluation, PMS/PSUR, vigilance/FSCA, UDI, PRRC).
- ISO 14971:2019 (risk management), with IEC 62304 (software) and IEC 62366-1 (usability) where applicable.
- MDSAP (recognized by Australia, Brazil, Canada, Japan, and the US) and ISO 9001:2015 cross-reference.
What is included within the ISO 13485 toolkit?
- 145+ professionally formatted, editable documents — encompassing the Quality Manual, policies, procedures, plans, templates, forms, registers, checklists, process maps, and other valuable documentation.
- 84 core controlled documents, 20 supporting forms, 23 branded QMS process maps (flowcharts), and 15 ready-to-use Excel registers/workbooks with built-in formulas.
- A How to Use This Toolkit guide and a FAQ to get you started quickly.
- Available as an instant download after purchase.
145+ Templates
Medical Devices Quality Management System Documentation pack — a complete and thorough set of documentation designed to assist manufacturers, importers, distributors, authorized representatives, consultants, and service providers in successfully achieving ISO 13485:2016 certification and demonstrating compliance with the FDA QMSR, EU MDR/IVDR, and MDSAP.
Pack folder structure:
Documents are organized into clear, clause-aligned folders that mirror ISO 13485:2016:
- 00 – QMS Process Maps
- 01 – Quality Management System & Documentation (Clause 4)
- 02 – Management Responsibility (Clause 5)
- 03 – Resource Management (Clause 6)
- 04 – Customer-Related Processes & Realization Planning (Clauses 7.1–7.2)
- 05 – Design & Development (Clause 7.3)
- 06 – Purchasing (Clause 7.4)
- 07 – Production & Service Provision (Clause 7.5)
- 08 – Sterile Devices & Sterilization (Clauses 7.5.5 / 7.5.7)
- 09 – Monitoring & Measuring Equipment (Clause 7.6)
- 10 – Measurement, Analysis & Improvement (Clause 8)
- 11 – Feedback, Complaints & Vigilance
- 12 – Risk Management (ISO 14971:2019)
- 13 – Regulatory Mapping & Assessment
- Plus a How to Use This Toolkit guide and a FAQ in the main folder.
List of all documents:
Getting Started
- How to Use This Toolkit (Guide)
- Frequently Asked Questions (FAQ)
00 — QMS Process Maps (23 branded flowcharts: Word + PNG + editable SVG)
- QMS Process Maps (compiled document)
- Clause 4 — Quality Management System
- Documentation Requirements
- Clause 5 — Management Responsibility
- Business Process Map
- Management — Customer Focus
- Operating Principles
- P-D-C-A — Objectives Planning
- Organization Chart
- Clause 6 — Resource Management
- Contributors — 5Ms + Environment
- Clause 7 — Product Realization
- Process Flow Chart (generic)
- Product Realization Quality Plan
- Customer Processes
- Design & Development
- Stage Gate — Idea to Launch
- Purchasing
- Process Control
- Process Steps — Control Points
- Identification & Traceability
- Clause 8 — Measurement, Analysis & Improvement
- Improvement — Maintain Effectiveness
- Corrective Action
01 — Quality Management System & Documentation (Clause 4)
- QMS-001 Quality Manual
- QMS-002 QMS & Process Interaction Procedure
- QMS-003 Control of Documents Procedure
- QMS-004 Control of Records Procedure
- QMS-005 Medical Device File Procedure & Index
- QMS-006 Master Document & Record List / Register (Word + Excel)
- QMS-007 QMS Software / Computer System Validation Procedure
- QMS-008 Control of Outsourced Processes Procedure
- QMS-F01 Document Change Request Form
- QMS-F02 Document Revision Checklist
- QMS-F03 QMS Software Inventory & Validation Register
- QMS-F04 Key Process Master List
- QMS-F05 Work Instruction Template
02 — Management Responsibility (Clause 5)
- MGT-001 Quality Policy
- MGT-002 Quality Objectives & KPI Register (Word + Excel)
- MGT-003 Management Review Procedure
- MGT-004 Management Review Input & Minutes Template
- MGT-005 Roles, Responsibilities & Authorities Matrix (RACI)
- MGT-006 Management Representative Appointment & Duties
- MGT-007 Internal Communication Procedure
- MGT-F01 Job Description Form
- MGT-F02 QMS Planning Worksheet
03 — Resource Management (Clause 6)
- RES-001 Human Resources & Competence Procedure
- RES-002 Training Plan & Competence Matrix / Register (Word + Excel)
- RES-003 Training & Competence Record Template
- RES-004 Infrastructure & Maintenance Procedure
- RES-005 Work Environment & Contamination Control Procedure
- RES-F01 Equipment Problem Report
- RES-F02 Equipment Maintenance Record
04 — Customer-Related Processes & Realization Planning (Clauses 7.1–7.2)
- CRP-001 Product Realization Planning Procedure
- CRP-002 Customer-Related Processes Procedure
- CRP-003 Customer Requirements Review Record Template
- CRP-F01 Quality Planning Table
05 — Design & Development (Clause 7.3)
- DES-001 Design & Development Control Procedure
- DES-002 Design & Development Plan Template
- DES-003 Design Inputs Specification Template
- DES-004 Design Outputs Record Template
- DES-005 Design Review Record Template
- DES-006 Design Verification Protocol & Report Template
- DES-007 Design Validation Protocol & Report Template
- DES-008 Design Transfer Procedure
- DES-009 Design Change Control Procedure
- DES-010 Design & Development File / Design History File (DHF) Index
- DES-011 Usability Engineering / Human Factors Procedure (IEC 62366-1)
- DES-012 Medical Device Software Development Lifecycle Procedure (IEC 62304)
- DES-013 Clinical Evaluation / Clinical Evidence Procedure (MDR Annex XIV)
06 — Purchasing (Clause 7.4)
- PUR-001 Purchasing & Supplier Control Procedure
- PUR-002 Supplier Evaluation, Selection & Re-evaluation Procedure
- PUR-003 Approved Supplier List (ASL) Register (Word + Excel)
- PUR-004 Purchasing Information / Requirements Specification Template
- PUR-005 Verification of Purchased Product / Incoming Inspection Procedure
- PUR-F01 Supplier Quality Report
- PUR-F02 Supplier Corrective Action Request (SCAR)
07 — Production & Service Provision (Clause 7.5)
- PRD-001 Control of Production & Service Provision Procedure
- PRD-002 Cleanliness of Product & Contamination Control Procedure
- PRD-003 Installation Activities Procedure
- PRD-004 Servicing Activities Procedure
- PRD-005 Process Validation Procedure
- PRD-006 Identification & Traceability Procedure
- PRD-007 Unique Device Identification (UDI) & Labelling Control Procedure
- PRD-008 Customer Property Procedure
- PRD-009 Preservation of Product Procedure
- PRD-010 Device Master Record (DMR) / Production Specification Index
- PRD-F01 Process Routing / Traveler Sheet
- PRD-F02 Process Validation Worksheet
- PRD-F03 Traceability / Serial-Number Log
- PRD-F04 Customer Property Control Log
- PRD-F05 Storage / Preservation Inspection Report
08 — Sterile Devices & Sterilization (Clauses 7.5.5 / 7.5.7)
- STE-001 Sterile Medical Devices Control Procedure
- STE-002 Sterilization Process Validation Procedure
- STE-003 Sterile Barrier System Validation Record Template
09 — Monitoring & Measuring Equipment (Clause 7.6)
- CAL-001 Control of Monitoring & Measuring Equipment Procedure
- CAL-002 Calibration Program & Recall Register / Log (Word + Excel)
10 — Measurement, Analysis & Improvement (Clause 8)
- MAI-001 Internal Audit Procedure
- MAI-002 Internal Audit Plan & Schedule Template
- MAI-003 Internal Audit Checklist Template (Word + Excel)
- MAI-004 Internal Audit Report & Finding Tracking Template
- MAI-005 Monitoring & Measurement of Processes & Product Procedure
- MAI-006 Control of Nonconforming Product Procedure
- MAI-007 Nonconformity Report (NCR) Template
- MAI-008 Rework Procedure
- MAI-009 Analysis of Data Procedure
- MAI-010 Corrective & Preventive Action (CAPA) Procedure
- MAI-011 CAPA Request & Tracking Register (Word + Excel)
- MAI-F01 Audit Scope by Work Area (Aid)
- MAI-F02 Product/Process Monitoring & Analysis Table
11 — Feedback, Complaints & Vigilance
- FBK-001 Feedback & Post-Market Surveillance (PMS) Procedure
- FBK-002 Complaint Handling Procedure
- FBK-003 Complaint Register / Log (Word + Excel)
- FBK-004 Regulatory Reporting & Vigilance Procedure (FDA MDR / EU MDR / IMDRF)
- FBK-005 Advisory Notice, Field Safety Corrective Action & Recall Procedure
- FBK-F01 Customer Satisfaction / Feedback Survey
12 — Risk Management (ISO 14971:2019)
- RSK-001 Risk Management Procedure (ISO 14971:2019)
- RSK-002 Risk Management Plan Template
- RSK-003 Risk Management File & Risk Assessment (FMEA) Template (Word + Excel)
- RSK-004 Risk Management Report Template
13 — Regulatory Mapping & Assessment
- REG-001 ISO 13485:2016 to FDA QMSR (21 CFR Part 820) Cross-Reference Matrix (Word + Excel)
- REG-002 ISO 13485:2016 to EU MDR 2017/745 Cross-Reference Matrix (Word + Excel)
- REG-003 ISO 13485:2016 to ISO 9001:2015 Cross-Reference Matrix (Word + Excel)
- REG-004 ISO 13485 Program Gap Assessment Workbook (Word + Excel)
- REG-005 ISO 13485 Certification / MDSAP Readiness Checklist (Word + Excel)
- REG-006 Applicable Regulatory Requirements Register (Word + Excel)
- REG-007 Statement of Applicability & Justification of Non-Applicable Requirements
- REG-008 ISO 13485 Glossary & Definitions Reference
All the documents of this toolkit are developed based on the ISO 13485:2016 Standard and cross-referenced to the FDA QMSR (21 CFR Part 820), EU MDR 2017/745 / IVDR 2017/746, ISO 14971:2019, IEC 62304, IEC 62366-1, and MDSAP.
Hence, you just need to download the selected document and add your company name and logo. (As the toolkit paraphrases the standards in original wording and does not reproduce their copyrighted text, you should hold a validly licensed copy of ISO 13485:2016 and any referenced standard.)
Frequently Asked Questions (FAQ)
What is the ISO 13485 Toolkit?
The ISO 13485 Toolkit is a complete collection of 145+ professionally designed, editable Word and Excel templates that help medical device organizations implement, certify, and maintain a compliant Quality Management System (QMS) based on ISO 13485:2016 — cross-referenced to the FDA QMSR (21 CFR Part 820, effective 2 February 2026), EU MDR 2017/745 / IVDR 2017/746, ISO 14971:2019, and MDSAP.
Who should use this toolkit?
It is ideal for medical device manufacturers, contract manufacturers, importers, distributors, authorized representatives, consultants, and service providers who want to streamline certification, meet US/EU regulatory requirements, and improve quality processes without starting from scratch.
What documents are included in the toolkit?
It includes the Quality Manual, 84 core policies and procedures, 20 supporting forms, 23 branded process maps, and 15 ready-to-use Excel registers (master document list, gap assessment, certification/MDSAP readiness checklist, CAPA register, complaint register, calibration log, FMEA, audit checklist, and the QMSR/MDR/ISO 9001 cross-reference matrices), plus a How to Use guide and FAQ — everything needed for ISO 13485 implementation, internal audits, and continual maintenance of QMS effectiveness.
Can I customize the documents?
Yes. All templates are in Microsoft Office format (Word and Excel) and come with clearly marked [bracketed] example content. You can easily insert your company name, logo, device scope, and specific processes to align the documents with your organizational needs.
Does this toolkit help with ISO 13485 certification and FDA QMSR / EU MDR compliance?
Absolutely. Whether you are seeking first-time certification or maintaining compliance, this toolkit provides audit-ready documentation aligned with certification bodies’ expectations and includes a Gap Assessment Workbook and a Certification/MDSAP Readiness Checklist that save significant time before and during the audit.
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