What is a quality management plan?
A quality management plan (QMP) is a documented plan that defines how a medical device team will meet its quality objectives on a specific product or project: which standards apply, who owns each quality activity, how quality assurance and quality control are carried out, and how results are measured.
It sits under your quality management system (QMS). The QMS sets company-wide procedures, and the plan applies them to one device or project. ISO 13485:2016 clause 7.1, which FDA's QMSR has incorporated by reference since February 2, 2026, requires the output of product realization planning to be documented in a form suitable for your organization. A quality management plan is a common way to meet that requirement.
Technically, you can launch a medical device without a quality management plan, but most of your go-to-market work will feel like guesswork.
Without an established quality management plan in place, you'll be faced with a number of potential unknowns and risks, any of which could derail your project. Manufacturing issue that results in nonconforming product? Slow complaint handling process that takes your product off the market? Poor training practices that lower personnel competence? All of these unfortunate scenarios can be prevented by a solid quality management plan.
Prioritizing quality matters when you're in a competitive market where every second counts and your reputation is critical. With a quality management plan in place, you're setting yourself up for an organized, predictable start. The best quality management plans provide a reliable framework that could mean the difference between hitting product deadlines and failing to launch at all.
This article provides a blueprint you can use to create a quality management plan that enables your company to achieve quality goals, redirects you if you go off course, and places your medical device in a position to excel in the marketplace.
Step 1: Start with an internal quality audit
Performing an internal quality audit allows you to check for any potential quality issues or unforeseeable roadblocks you may encounter after your plan is put in motion.
From there, you can create a quality management plan that accounts for potential areas of concern that were uncovered during the audit.
Follow these tips to run a quick, reliable internal audit:
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Avoid the immediate temptation of hiring a third-party auditor if possible, and instead, rely on your own internal team to structure the quality audit. This internal team member could be a quality manager or team lead who understands how the company functions and has a good understanding of the applicable regulations and standards.
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Make a list of every team that will be impacted by the quality audit and give as early of notification as possible. Audits tend to go smoothly when everyone is on board and prepared. Your role is not FDA Inspector, so a surprise inspection is not necessary and ultimately will provide little value as compared to the high value that can be gained from a well-executed quality audit.
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Implement an electronic system for documenting your findings. Don’t rely on a pen and paper. The last thing you want is to lose everything or forget where key documents are stored. A lazy quality audit will turn into a sloppy QMP.
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Avoid the costly mistake of conducting an internal audit at the end of the year. Quality audits deserve your full attention, so make sure you give this activity proper due diligence. A good rule of thumb is to perform quarterly internal audits, if possible, to stay on top of any potential issues or shifts before they become systemic.
An internal audit is more than a to-do list item. If it feels like a chore, try to view your quality audit as an opportunity to improve your product, processes or even company culture. This simple mindset shift can help you and everyone involved get the utmost value out of the exercise and ensure you are prepared for the potential unannounced audits to come.
Step 2: Define the project scope
Building a quality management plan before understanding the scope of the project itself is putting the cart before the horse. You need to understand how big the overall project is before creating a plan to tackle it.
There are a few practices you can put into place to determine the scope and keep your plan from under- or overshooting your project goals.
Before meeting with any stakeholders though, brainstorm an aggressive deadline for the project among your immediate team. Then, set a more conservative deadline and present it to the stakeholders. A conservative deadline helps you establish wiggle room and avoid any kind of crunch or late deliveries on promises.
When you do eventually meet with stakeholders to formalize your project scope, speak with each member to gain a clear understanding of their expected involvement in the project. Since your plan will set the foundation for your project, you’ll want to make sure everyone’s on the same page before actually drafting the plan. Specifically, you’ll want to determine the following things during this meeting:
- What they’re hoping your project accomplishes
- If there are new markets they wish to enter with a product you’re working on
- How involved they plan on being with the project
And make sure to temper expectations as well. You know what your team is capable of. If certain stakeholders are asking for a reinvention of the wheel, remind them that it is not doable, or in your wheelhouse.
Take note of any areas where your product and processes vary from what the market will need. If there are numerous discrepancies between your current product or processes and what customers want, the scope of your QMP will likely be extensive and unwieldy.
Step 3: Write your quality management plan
With the biggest preliminary tasks out of the way, it’s time to create your quality management plan.
There is no one-size-fits-all template, but the outline below works for most devices.
Most medical device quality management plans cover the same ten sections:
- Scope and business case: the device, its intended use, the project phase, and why quality is central to the business case.
- Quality objectives and metrics: measurable targets such as first-pass yield, complaint rate, or on-time CAPA closure, each with an owner and a review date.
- Applicable regulations and standards: for example ISO 13485, 21 CFR Part 820 (QMSR), ISO 14971, IEC 62304 for software, and EU MDR where you plan to sell.
- Roles and responsibilities: who approves documents, chairs design reviews, runs the material review board, and signs off on releases.
- Quality assurance activities: design reviews, supplier qualification, training, and internal audits that prevent defects.
- Quality control activities: inspections, tests, sampling plans, and acceptance criteria that catch defects in finished work.
- Risk management: how your ISO 14971 risk management file feeds design and production decisions.
- Document and record control: where controlled documents live and how records stay audit-ready.
- Nonconformance and CAPA: how quality events are logged, investigated, and closed through your CAPA process.
- Communication and change control: who is notified when issues arise, and how changes to the plan are reviewed, approved, and trained.
Your plan shouldn’t be a static document. If you notice something isn’t working out as planned, find a solution and update your plan to reflect those changes.
It’s important to note that any changes to your plan should be clearly documented then communicated to all stakeholders. Additional steps, such as training, may be necessary depending on the complexity of the change.
Quality management plan vs. QMS vs. quality manual
- QMS: the company-wide system of processes, procedures, and records that meets ISO 13485 and the QMSR.
- Quality manual: the top-level document that describes your QMS, its scope, and how its processes interact. See our guide to the ISO 13485 quality manual.
- Quality management plan: a product- or project-level plan that applies the QMS to one device, with its own objectives, owners, and checkpoints.
Keep the plan short and point to existing SOPs rather than copying them. When a procedure changes, update the reference in the plan instead of restating the procedure.
Step 4: Confirm the resources you need
Every quality management plan will require certain resources that must be in place before formalizing it, let alone executing it.
In order to make preparing and implementing your quality management plan easier and smoother, do the following:
- Adopt the best tools for the job. Do you have any project management tools or a quality system in place? If so, look at their capabilities through the lens of your plan. Will these tools support your team's efforts in successfully executing the plan, or do you need a more robust solution? You’ll want the right quality management tools that are capable of enabling your continued growth and scaling with your company.
- Develop a material review board, if you don’t have one. A material review board (MRB) can serve as a valuable asset to your company by reviewing any quality issues flagged by employees and facilitating the change management process that may need to be taken. Quality issues are inevitable, and this MRB can help in both the short and long haul all while ensuring your plan is adhered to.
- Confirm resource capacity. Assess the workload that your upcoming project will demand. Are there any new tasks, potential inefficiencies, or other reasons your current resources may not be able to handle? Perform trial runs of any new processes to get an even better idea of whether or not you’ll need additional hires.
It’s hard to predict with full accuracy if you have the necessary resources to carry out your quality management plan before putting it into practice. There’s a high likelihood you’ll need to make changes along the way after the plan is already in motion, which should not derail your plan so long as you prepare accordingly and communicate effectively when there is a pivot.
Step 5: Put the plan into action
The preliminary work of creating your quality management plan is done; now it’s time to actually put your plan into action. The right quality system makes it easy to create, implement, and follow your quality management plan.
The best QMS software will enhance your efforts by allowing you to operate within controlled environments through medical device-specific workflows designed to support your project, enabling you to securely store and easily access documents, communicate within and across teams, and produce a safe and effective medical device.
Greenlight Guru offers a purpose-built quality management solution for MedTech. Greenlight Guru's Quality Management Software automatically stays up to date with the latest regulations and standards, removing the burden of achieving and maintaining compliance so you can focus on developing the highest quality of products possible.
A quality management plan is easier to run when objectives, documents, training, and CAPAs live in one system. See how Greenlight Guru connects them with a free personalized demo of our QMS software.
Looking for an all-in-one QMS solution to advance the success of your in-market devices and integrates your quality processes with product development efforts? Click here to take a quick tour of Greenlight Guru's QMS software
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Medical Device Project Plan
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