Medical Devices Quality Management
Shows a quality system that meets medical device regulatory expectations.
A complete documentation kit written to ISO 13485:2016: quality manual, policies, procedures, SOPs, forms, registers, process maps, indicator and risk frameworks, audit and management review packs, an implementation roadmap, sector guides and commercial templates, with every clause mapped to the document that meets it, and risk management, the medical device file, design controls, validation, traceability and post-market complaint handling built into the system.
- Edition 2016
- 183 Word + 31 Excel files
- One organization
- Downloads open 7 days after payment
You need this if
- You design, make, sterilize, distribute or service medical devices.
- A regulator or distributor asks for ISO 13485 certification.
- You need design controls, a medical device file and complaint reporting in one system.
Look here instead if your products are not medical devices. ISO 9001 is the general quality standard. ISO 9001:2026 Quality Management Systems →
What you get, in numbers
Counted from the files in the pack. Every file title is listed further down.
What this toolkit is not
Worth knowing before you buy.
Not the certificate
Certification is decided by an independent certification body after it audits a system you have run for some months, with records. No toolkit can guarantee it.
Not the ISO text
The standard is copyrighted and sold by ISO and national standards bodies. Buy your own copy. The toolkit describes requirements in its own words.
Not a consultant
We do not assess your organization. You review, adapt and approve every document before you use it.
What’s inside
15 numbered folders. Open any folder to see the title of every file in it. Titles only: the files themselves are delivered after payment.
00Start Here
Six guides: read-me, how to implement with an initial review checklist, documentation structure, quick start, an ISO 13485:2016 clause mapping guide with the points that differ from ISO 9001, and a certification preparation guide.
6 files
- WordSH-001 Read Me Guide
- WordSH-002 How to Implement Guide
- WordSH-003 Documentation Structure Guide
- WordSH-004 Quick Start Guide
- WordSH-005 ISO 13485-2016 Clause Mapping Guide
- WordSH-006 Certification Preparation Guide
01Master Index
One Excel register of every controlled document: number, title, type, owner, department, retention and clause, with review dates and overdue flags.
1 file
- ExcelREG-01 Master Document Register
02Manual
The Quality Manual required by clause 4.2.2, section-numbered to match clauses 4 to 8: scope and role under regulations with justified exclusions, the QMS and medical device file, management responsibility, resources, product realization with risk management, design controls, purchasing, production, validation and traceability, and measurement, analysis and improvement.
1 file
- WordQM-001 Quality Manual
03Procedures (P-001 to P-026)
Document and record control, scope and outsourced processes, management responsibility, regulatory requirements, medical device file, risk management, resources and maintenance, competence, work environment and contamination control, realization planning and customer requirements, design planning, review, verification and validation, transfer and changes, purchasing, production and servicing, sterile devices, process and software validation, identification and UDI, customer property and measuring equipment, complaints and regulatory reporting, internal audit, release, nonconforming product and advisory notices, data analysis and management review, and CAPA. Each has a flowchart, responsibility table, controls, risk and indicator matrices.
26 files
- WordP-001 Document Control Procedure
- WordP-002 Record Control Procedure
- WordP-003 QMS Scope, Planning and Outsourced Processes Procedure
- WordP-004 Management Responsibility, Policy, Objectives and Communication Procedure
- WordP-005 Regulatory Requirements Management Procedure
- WordP-006 Medical Device File Procedure
- WordP-007 Risk Management Procedure
- WordP-008 Resources, Infrastructure and Maintenance Procedure
- WordP-009 Competence, Training and Awareness Procedure
- WordP-010 Work Environment and Contamination Control Procedure
- WordP-011 Planning of Product Realization and Customer Requirements Procedure
- WordP-012 Design and Development Planning, Inputs and Outputs Procedure
- WordP-013 Design Review, Verification and Validation Procedure
- WordP-014 Design Transfer, Changes and Files Procedure
- WordP-015 Purchasing and Supplier Control Procedure
- WordP-016 Production, Cleanliness, Installation and Servicing Procedure
- WordP-017 Sterile Devices and Sterile Barrier Systems Procedure
- WordP-018 Process and Software Validation Procedure
- WordP-019 Identification, Traceability and UDI Procedure
- WordP-020 Customer Property, Preservation and Monitoring Equipment Procedure
- WordP-021 Feedback, Complaint Handling and Regulatory Reporting Procedure
- WordP-022 Internal Audit Procedure
- WordP-023 Monitoring, Measurement and Product Release Procedure
- WordP-024 Control of Nonconforming Product, Advisory Notices and Rework Procedure
- WordP-025 Analysis of Data and Management Review Procedure
- WordP-026 Corrective and Preventive Action and Improvement Procedure
04Policies (POL-001 to POL-014)
Quality policy, document control, record retention for the lifetime of the device, regulatory compliance, risk management, competence, design and development, purchasing and suppliers, production and cleanliness, identification and traceability, post-market surveillance and complaints, nonconforming product and recall, software validation, and audit, review and improvement.
14 files
- WordPOL-001 Quality Policy
- WordPOL-002 Document Control Policy
- WordPOL-003 Record Retention Policy
- WordPOL-004 Regulatory Compliance Policy
- WordPOL-005 Risk Management Policy
- WordPOL-006 Competence, Training and Awareness Policy
- WordPOL-007 Design and Development Policy
- WordPOL-008 Purchasing and Supplier Control Policy
- WordPOL-009 Production, Cleanliness and Work Environment Policy
- WordPOL-010 Identification, Traceability and Customer Property Policy
- WordPOL-011 Post-Market Surveillance, Complaints and Vigilance Policy
- WordPOL-012 Nonconforming Product, Advisory Notices and Recall Policy
- WordPOL-013 Software and Computerised Systems Validation Policy
- WordPOL-014 Internal Audit, Management Review and Improvement Policy
05SOP Library (SOP-001 to SOP-031)
Step-by-step task instructions with flowcharts and acceptance criteria: document issue, regulatory watch, device file compilation, risk analysis and control verification, cleanroom gowning, environmental monitoring, design review, verification and validation, design transfer, supplier approval, incoming inspection, line clearance and batch records, installation and servicing, sterilization release, process and software validation, labelling and UDI, traceability tests, calibration, complaint handling, regulatory reporting, internal audit, release, nonconforming product, recall, and CAPA.
31 files
- WordSOP-001 Document Issue and Withdrawal
- WordSOP-002 Records Filing and Retention
- WordSOP-003 Quality Planning Review
- WordSOP-004 Regulatory Watch and Update
- WordSOP-005 Medical Device File Compilation
- WordSOP-006 Risk Analysis Workshop
- WordSOP-007 Risk Control Verification and Reporting
- WordSOP-008 Competence Assessment and Training
- WordSOP-009 Cleanroom Gowning and Hygiene
- WordSOP-010 Environmental Monitoring
- WordSOP-011 Design Review Meeting
- WordSOP-012 Design Verification Testing
- WordSOP-013 Design Validation and Clinical Evaluation
- WordSOP-014 Design Transfer
- WordSOP-015 Supplier Approval and Audit
- WordSOP-016 Incoming Inspection
- WordSOP-017 Line Clearance and Batch Record Completion
- WordSOP-018 Installation and Servicing
- WordSOP-019 Sterilization Release
- WordSOP-020 Process Validation
- WordSOP-021 Software Validation
- WordSOP-022 Labelling and UDI Control
- WordSOP-023 Traceability Exercise
- WordSOP-024 Calibration
- WordSOP-025 Complaint Handling
- WordSOP-026 Regulatory Reporting
- WordSOP-027 Internal Audit Conduct
- WordSOP-028 Final Inspection and Release
- WordSOP-029 Nonconforming Product Handling
- WordSOP-030 Field Safety Corrective Action and Recall
- WordSOP-031 CAPA Tracking
06Forms (FR-001 to FR-074)
Seventy-four forms. Each comes with field descriptions, a blank form that prints on its own, and a completed example record.
74 files
- WordFR-001 Document Change Request
- WordFR-002 Document Distribution Log
- WordFR-003 Document Review Record
- WordFR-004 Record Disposal Authorization
- WordFR-005 QMS Scope and Applicability Statement
- WordFR-006 Outsourced Process Control Record
- WordFR-007 Quality Objectives Plan
- WordFR-008 Roles, Responsibility and Authority Matrix
- WordFR-009 Internal Communication Record
- WordFR-010 Regulatory Requirements Review
- WordFR-011 Regulatory Change Assessment
- WordFR-012 Medical Device File Index
- WordFR-013 Risk Management Plan
- WordFR-014 Hazard Analysis and Risk Estimation
- WordFR-015 Risk Control Verification Record
- WordFR-016 Risk Management Report
- WordFR-017 Post-Production Risk Review
- WordFR-018 Resource Request
- WordFR-019 Equipment Maintenance Record
- WordFR-020 Role Competence Definition
- WordFR-021 Competence Assessment Form
- WordFR-022 Training Attendance Record
- WordFR-023 Training Effectiveness Evaluation
- WordFR-024 Health and Hygiene Record
- WordFR-025 Environmental Monitoring Record
- WordFR-026 Product Realization Plan
- WordFR-027 Customer Requirements Review Record
- WordFR-028 Design and Development Plan
- WordFR-029 Design Input Record
- WordFR-030 Design Output Record
- WordFR-031 Design Review Record
- WordFR-032 Design Verification Record
- WordFR-033 Design Validation and Clinical Evaluation Record
- WordFR-034 Design Transfer Checklist
- WordFR-035 Design Change Assessment
- WordFR-036 Design and Development File Index
- WordFR-037 Supplier Evaluation Record
- WordFR-038 Purchasing Information Record
- WordFR-039 Incoming Inspection Record
- WordFR-040 Supplier Performance Review
- WordFR-041 Device History Record
- WordFR-042 Line Clearance Record
- WordFR-043 Installation and Servicing Record
- WordFR-044 Sterilization Cycle Record
- WordFR-045 Process Validation Protocol and Report
- WordFR-046 Software Validation Record
- WordFR-047 Traceability Exercise Record
- WordFR-048 UDI Assignment Record
- WordFR-049 Customer Property Record
- WordFR-050 Instrument Calibration Record
- WordFR-051 Out-of-Tolerance Impact Assessment
- WordFR-052 Post-Market Surveillance Plan
- WordFR-053 Complaint Record
- WordFR-054 Complaint Investigation Record
- WordFR-055 Regulatory Reporting Decision Record
- WordFR-056 Annual Audit Programme
- WordFR-057 Audit Plan
- WordFR-058 Internal Audit Checklist
- WordFR-059 Audit Report
- WordFR-060 Auditor Competence Record
- WordFR-061 Process Monitoring Record
- WordFR-062 In-Process and Final Inspection Record
- WordFR-063 Product Release Record
- WordFR-064 Nonconforming Product Report
- WordFR-065 Rework Instruction and Approval
- WordFR-066 Advisory Notice and Recall Record
- WordFR-067 Data Analysis Report
- WordFR-068 Management Review Agenda
- WordFR-069 Management Review Minutes
- WordFR-070 Management Review Action Plan
- WordFR-071 CAPA Request
- WordFR-072 CAPA Investigation and Action Plan
- WordFR-073 CAPA Effectiveness Review
- WordFR-074 Improvement Suggestion Form
07Registers (REG-01 to REG-17)
Seventeen Excel registers with examples, drop-down lists, automatic calculations, due dates and overdue flags: documents, records, regulatory requirements, medical device files, risk management (with a risk score rule), design projects, suppliers, competence, measuring equipment, validations, traceability and distribution, complaints, regulatory reports and advisory notices, nonconformities and CAPA, audits, changes, and objectives.
17 files
- ExcelREG-01 Document Register
- ExcelREG-02 Record Register
- ExcelREG-03 Regulatory Requirements Register
- ExcelREG-04 Medical Device File Register
- ExcelREG-05 Risk Management Register
- ExcelREG-06 Design Project Register
- ExcelREG-07 Approved Supplier Register
- ExcelREG-08 Training and Competence Register
- ExcelREG-09 Monitoring and Measuring Equipment Register
- ExcelREG-10 Process and Software Validation Register
- ExcelREG-11 Traceability and Distribution Register
- ExcelREG-12 Complaint Register
- ExcelREG-13 Regulatory Reporting and Advisory Notice Register
- ExcelREG-14 Nonconformity and CAPA Register
- ExcelREG-15 Audit Register
- ExcelREG-16 Change Register
- ExcelREG-17 Objectives and Programme Register
08Process Maps
Eight swimlane maps with inputs, outputs, owners and indicator links: management and regulatory, risk and device files, design, purchasing, production and sterile devices, validation and traceability, post-market and complaints, and release, CAPA, audit and review.
8 files
- WordPM-01 Management, Regulatory and Planning Process Map
- WordPM-02 Risk Management and Medical Device File Process Map
- WordPM-03 Design and Development Process Map
- WordPM-04 Purchasing and Supplier Control Process Map
- WordPM-05 Production, Cleanroom and Sterile Devices Process Map
- WordPM-06 Validation, Traceability and Measuring Equipment Process Map
- WordPM-07 Post-Market, Complaints and Reporting Process Map
- WordPM-08 Release, Nonconformity, CAPA, Audit and Review Process Map
09Indicators & Risk
88 QMS and device indicators with formulas and targets in a filterable matrix, corporate and department frameworks, a balanced scorecard, a 5 x 5 risk matrix with 40 example risks, and an improvement opportunity matrix with 25 examples.
6 files
- WordKPI-01 Corporate Medical Device QMS Indicator Framework
- WordKPI-02 Department Indicator Framework
- ExcelKPI-03 Balanced Scorecard
- ExcelKPI-04 Process Indicator Matrix
- ExcelRSK-01 Risk Management Matrix
- ExcelRSK-02 Opportunity Matrix
10Audit
Annual audit programme covering every clause and regulatory requirement, audit plan, notification, auditor competence matrix, a 70-question checklist by clause, a complete audit report and a findings tracker.
7 files
- WordAUD-01 Annual Audit Programme
- WordAUD-02 Audit Plan
- WordAUD-03 Audit Notification
- ExcelAUD-04 Auditor Competence Matrix
- ExcelAUD-05 Audit Checklist by Clause
- WordAUD-06 Audit Report
- ExcelAUD-07 Follow-up Tracker
11Management Review
Agenda, inputs checklist covering every item of clause 5.6.2, completed sample minutes with the required outputs, action plan and a dashboard.
5 files
- WordMRV-01 Management Review Agenda
- WordMRV-02 Management Review Inputs Checklist
- WordMRV-03 Management Review Minutes Template
- ExcelMRV-04 Management Review Action Plan
- ExcelMRV-05 Management Review Dashboard
12Implementation
An eight-month roadmap with activities, milestones, deliverables and responsibilities, and a task tracker.
2 files
- WordIMP-01 Implementation Roadmap
- ExcelIMP-02 Implementation Tracker
13Customization
Guides with risks, controls and indicators for single-use sterile devices, active electronic devices and software, orthopaedic and implantable devices, in vitro diagnostics, dental devices, wound care, contract manufacturers and suppliers, distributors and importers, sterilization and packaging providers, and reusable devices and servicing.
10 files
- WordCUS-01 Single-Use Sterile Devices Customization Guide
- WordCUS-02 Active Electronic Devices and Software Customization Guide
- WordCUS-03 Orthopaedic and Implantable Devices Customization Guide
- WordCUS-04 In Vitro Diagnostics Customization Guide
- WordCUS-05 Dental Devices and Consumables Customization Guide
- WordCUS-06 Wound Care and Dressings Customization Guide
- WordCUS-07 Contract Manufacturers and Component Suppliers Customization Guide
- WordCUS-08 Distributors and Importers Customization Guide
- WordCUS-09 Sterilization and Packaging Service Providers Customization Guide
- WordCUS-10 Reusable Devices, Reprocessing and Servicing Customization Guide
14Commercial
Gap assessment checklist, certification readiness checklist, implementation and training proposal templates, consultancy agreement template and audit preparation checklist.
6 files
- ExcelCOM-01 Gap Assessment Checklist
- ExcelCOM-02 Certification Readiness Checklist
- WordCOM-03 Implementation Proposal Template
- WordCOM-04 Training Proposal Template
- WordCOM-05 Consultancy Agreement
- ExcelCOM-06 Audit Preparation Checklist
Sample pages
Pages from the delivered files, before your company details are applied.
After you download
The order most organizations follow.
Before you buy
Is the text of ISO 13485:2016 included?
No. The standard is copyrighted by ISO and sold by ISO and national standards bodies. Buy your own copy. The toolkit describes requirements in its own words and maps every clause to the document that meets it, so you can check each against the standard.
Which edition does the kit follow?
ISO 13485:2016, which was reconfirmed at its last systematic review. Regulators apply it in their own ways: the European Union harmonizes it as EN ISO 13485:2016 with a regional amendment, and the US FDA incorporates it by reference into its quality management system regulation. Check the requirements of your own markets and the status of the standard when you start.
Does the kit replace a technical file or regulatory submission?
No. It is a QMS documentation set. It does not replace advice on device classification, conformity assessment, clinical evaluation, device registration or risk management expertise. The kit gives you the system and the records into which those activities fit.
Are the examples, limits and timelines real data?
No. Names, device details, test limits, retention periods, reporting timelines and figures in example records are fictional and marked as examples. Your own must come from your risk management, regulations and notified body or certification body.
Can we edit the documents after purchase?
Yes. Files are delivered as standard, unlocked .docx and .xlsx files. Nothing is watermarked or restricted. Items such as prepared-by names and company profile facts are left for you to complete.
Will this get us certified on its own?
The toolkit gives you a complete, clause-mapped documentation baseline and tools for operating the system. Certification and regulatory approval are decided by independent bodies after they audit a working system, including sampling of records and observation of operations, so you must run the system for some months first. Neither a toolkit nor a management system guarantees safe devices, regulatory approval or certification.
How long can we download the files?
For 7 days from payment. In that time you can enter your company details, correct them and regenerate, and download as often as you need. After 7 days the purchase stays in your account history, but the download closes. Save the ZIP somewhere safe.
What if we need the files again later?
Buying the same toolkit again is a new order with its own 7-day download window. Each purchase is listed separately in your account.
Licence
One purchase licenses one organization to use, edit and adapt the documents for its own management system. You may not resell, share or publish the toolkit or its templates. Each file carries a footer line with the buyer’s email and order number. Full wording is in the Terms & licence.