ISO 13485 Quality Plan Template
This ISO 13485 quality plan template gives you a plan for one device or family, a medical device file contents example and a clause compliance checklist, all in a single exportable document. Fill in the fields and download it as Word or PDF.
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ISO 13485 Quality Plan Template with Medical Device File Example
Quality Plan
Meridian Medical Components Inc Product: Single-use laparoscopic grasper, model LG-5 Classification: Class II Document: QPL-LG5-001 Rev A Markets: USA (FDA 510(k)), EU (MDR), Canada (MDSAP) Owner: Quality engineer
1. Scope and quality objectives
This plan defines the processes, resources, records and checks required to realize Single-use laparoscopic grasper, model LG-5 in line with the quality management system. Objectives: Meet all design inputs and verify with documented evidence. First-pass yield at final inspection of at least 98 percent. No open critical supplier nonconformances at release.
2. Risk management
Risk management per ISO 14971 is run through the life cycle. Hazard analysis, FMEA and a risk management report are updated at each design review and at any change.
3. Product realization plan
| Stage | Key activities | Output / record | Responsible | Planned date |
|---|---|---|---|---|
| Design and development planning | Plan, inputs, roles | Design plan | ||
| Design inputs and outputs | Requirements, specifications | Design input and output records | ||
| Design verification and validation | Test protocols and reports | V&V reports, usability file | ||
| Purchasing | Supplier selection and evaluation | Approved supplier list, quality agreements | ||
| Production and process control | Process validation, work instructions | IQ/OQ/PQ reports, routings | ||
| Cleaning, sterilization, packaging | Validated cycles | Validation reports, labeling records | ||
| Final inspection and release | Acceptance criteria | Device history record | ||
| Post-market surveillance | Complaints, vigilance | Complaint files, trend reports |
4. Medical device file contents example
| Section | Content | Reference document | Status |
|---|---|---|---|
| General description | Intended use, indications, user, device description | DD-LG5-001 | Complete |
| Labeling | Label, instructions for use, packaging | LB-LG5-010 | Complete |
| Product specifications | Drawings, bill of materials, performance requirements | DR-LG5-100 | Complete |
| Manufacturing specifications | Process flow, work instructions, in-process and final acceptance | MP-LG5-200 | In progress |
| Purchasing and supplier | Specifications and quality agreements for key components | PU-LG5-030 | In progress |
| Measuring and monitoring | Test methods, gauge control, sampling plans | TM-LG5-040 | Open |
| Installation and servicing | Where applicable, procedures and acceptance | N/A single-use | Not applicable |
| Risk management file | Risk plan, analysis and report | RM-LG5-001 | In progress |
| Verification and validation | Protocols, reports and traceability to inputs | VV-LG5-001 | Open |
5. Compliance checklist
| Check | Clause area | Evidence | Met (Y/N) |
|---|---|---|---|
| Quality plan approved before design release | 7.1 Planning of product realization | This document | |
| Regulatory requirements identified for each market | 4.1.1 and 7.2.1 | Regulatory strategy | |
| Design controls records complete | 7.3 | Design history file | |
| Suppliers evaluated and monitored | 7.4 | Approved supplier list | |
| Production processes validated | 7.5.6 | Validation reports | |
| Traceability and identification defined | 7.5.8 and 7.5.9 | Traceability procedure | |
| Nonconforming product controlled | 8.3 | NCR procedure and log | |
| Complaint and feedback process active | 8.2.1 and 8.2.2 | Complaint procedure | |
| CAPA system effective | 8.5.2 and 8.5.3 | CAPA log |
Approvals
Starting template only. Requirements differ by device class, market and regulation (for example FDA 21 CFR 820, EU MDR, MDSAP). Clause references follow ISO 13485:2016 structure but you must confirm them against your own copy of the standard. The medical device file replaces the older device master record concept in many systems, but FDA terminology may still apply to your US submissions.
Medical device file gap check
Optional: we can map your device records across ERP and document stores and list missing items.
Optional. The tool and every export work without this. No spam.
How to use the template
Start with the device, classification and markets, since these drive the evidence you will need. Then write objectives that can be measured. Walk the product realization table row by row and assign an owner and a date to every stage. Use the medical device file table as an index to documents that live in your document control system rather than copying content into this plan. Finally, tick the checklist at each design review so gaps are visible early.
- One plan per device or family, not per site
- Link to controlled documents instead of pasting them
- Review at every design gate and after any change
- Keep superseded versions per your retention rules
What ISO 13485 asks for
Clause 7.1 requires you to plan and develop the processes needed for product realization, including quality objectives, resources, verification, validation, monitoring, inspection and test activities, and the records needed. Clause 4.2.3 requires a medical device file for each type or model, describing the device and all documents on its specification and manufacturing, packaging, labeling, procedures and, where relevant, installation and servicing. The plan above pulls these two requirements into one document.
Reading the checklist
Treat each row as a question you must answer with evidence. A row that is marked N needs an action, an owner and a date. Do not mark a clause as met because a procedure exists: auditors look for records that show the procedure was followed on this device. If a requirement does not apply, such as servicing for a single-use device, record the justification rather than leaving the row blank.
Common mistakes
Plans that restate the quality manual, no link between risk management and design inputs, supplier controls that stop at an approved list, and medical device files that exist only as a folder with no index. Another is writing the plan after design is complete. It should exist before design work starts and be updated as the project learns.
Frequently Asked Questions
Is a quality plan required by ISO 13485?
ISO 13485 requires planning of product realization and documented evidence of it, and many organizations meet this with a quality plan per device or project. The format is yours to define as long as it covers objectives, processes, resources, activities and records.
What goes in a medical device file?
A general description, intended use, labeling, product specifications, manufacturing and packaging specifications, procedures for purchasing, measuring and monitoring, installation and servicing where applicable, and risk management records. It can be an index that points to controlled documents.
How does the medical device file relate to the DHF and DMR?
ISO 13485 uses the medical device file. In the US, FDA rules use the design history file, device master record and device history record. Many companies keep one structure and map the content to each term for audits.
When should the quality plan be updated?
At each design review, after any significant design, process or supplier change, and when regulatory requirements change. Keep revision history so an auditor can see how planning evolved over the project.
If your device records live across ERP, document stores and spreadsheets, we can put a private AI layer on your own servers to answer which records exist for a device and what is missing.
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