QMS Quality Manual: Quality Policy and Quality Objectives
Sven Piechottka
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Quality Management
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Updated December 17, 2024
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Quality Manual
, Quality Objectives
, Quality Policy
You are just starting to set up your QMS quality manual? When setting up your QMS, this is one of the first documents slammed at your face. You describe your organization, applicable regulation ... and wait, what's the quality policy and objectives? This is where the "fun" begins. I'm not here to make this topic more exciting (sorry). I'll try to give ideas for your writing process and for making this task less burdensome going forward.
This article gives you some practical tipps on how to set up your QMS quality manual, specifically setting up the quality policy (QP) and quality objectives (QO) for your quality management system (QMS). Here's the short summary:
This article gives you some practical tipps on how to set up your QMS quality manual, specifically setting up the quality policy (QP) and quality objectives (QO) for your quality management system (QMS). Here's the short summary:
- You have a lot of freedom in what you write and what kind of tracking system you set up to follow through on your objectives.
- Minimum requirements: every aspect of your policy must translate into a measurable objective.
Be prepared to explain this to your auditor. Track your progress in achieving the quality objectives throughout the year and document an assessment at least once per year. - You already have a system in place to keep track of your company strategic objectives? Integrate this in your quality management system and minimize your workload.
(By the way, if you need somebody to walk through the entire template for a quality manual with you, here's our free Wizard video on this.)
QMS Quality Manual: Here are the Actual Requirements
Quality policy and objectives don't really play a role in the MDR. Your most relevant requirements are found in the ISO 13485 norm. So ... *blowing the dust off my PDF*.
Involve Management
Before all, note that this topic is part of ISO 13485 chapter 5 on 'Management Responsibility'. Are you one of those employees who drew the short end of the stick to take care of all this regulatory stuff?
A little piece of good news: this is a topic where auditors want to see Management getting involved. For the start, suggest that your CEO with that MBA degree writes the quality policy himself. Chances are, there is already a "mission & vision" document floating in one of his drawers. He can re-use that and spice it up with some quality buzz words. Moving forward, your Management is also responsible for (= at least needs to sign off on) QMS planning files and for reviewing it for continued suitability.
A little piece of good news: this is a topic where auditors want to see Management getting involved. For the start, suggest that your CEO with that MBA degree writes the quality policy himself. Chances are, there is already a "mission & vision" document floating in one of his drawers. He can re-use that and spice it up with some quality buzz words. Moving forward, your Management is also responsible for (= at least needs to sign off on) QMS planning files and for reviewing it for continued suitability.
Quality Policy: Consider Your Individual Company Setup
Your next question might be: what are the essential parts of your QMS quality manual, i.e. good quality policy and quality objectives? The norm mentions "a commitment to comply with requirements", and "maintaining QMS effectiveness" as aspects for the quality policy. And your quality objectives should help you meet regulatory and product requirements. That's it? Well ... yes. We note that, on one hand, you have a lot of freedom to define the relevant content for your QP/QO. On the other hand, auditors will expect that you described your company-specific setup, and that you didn't just copy/paste the talking points of Save The Children. Here's some classics:
- Improve patient benefits. Whatever those might be in your case.
- Compliance: you obviously want to be a good, law-abiding medical device manufacturer!
- Organizational excellence: you want hire the top experts and brightest minds of your industry, and continuously train your employees to improve their qualification.
- Responsiveness to customers: take feedback from your customers seriously.
Quality Objectives: Measurable and Consistent
Moving on, the ISO 13485 now wants you to formulate concrete objectives by which you can track how and eventually decide if you have met your quality policy or not. Note that they should also help you to meet product requirements, so it's encourage to bring in product-specifics here. And also note that quality objectives should be established at all relevant functions and levels of the organization, meaning that each team of your company should have an objective related to the QMS. Again, here's some general examples:
- Qualification of Employees: only hire people that meet pre-defined qualification requirements, complete onboarding training on time, conduct regular re-training.
- Customer Satisfaction: fast customer support response times, fast implementation of their feedback, and maybe you're planning to conduct a user survey next year?
- Accessibility of Product: obviously, your product is awesome. You want as many people as possible to have access to it. Planning to launch in a new market next year? That makes it easy to put a number on it.
Lastly, another relevant aspect: just like the quality policy should "provide a framework for establishing and reviewing quality objectives", the quality objectives must be consistent with the quality policy.
In simple words: you should be able to explain to your auditor how each aspect of your quality policy translates into a quality objective. Think of it as a cascade of water, flowing from abstract to specific.
Quick recap. In a simple example, you can mention "organizational excellence" as part of you quality policy. Amongst others, this can be translated into the objective of "high employee qualification". Throughout the year, you can plan to conduct several employee trainings. At the year's end, you can easily assess if the objective has been reached or not. Done!
In simple words: you should be able to explain to your auditor how each aspect of your quality policy translates into a quality objective. Think of it as a cascade of water, flowing from abstract to specific.
Quick recap. In a simple example, you can mention "organizational excellence" as part of you quality policy. Amongst others, this can be translated into the objective of "high employee qualification". Throughout the year, you can plan to conduct several employee trainings. At the year's end, you can easily assess if the objective has been reached or not. Done!
Recommendation: Use What You Already Have For Your QMS Quality Manual
We've learned before that your quality policy and objective must be checked for continued suitability. That's a Management responsibility which is typically part of the annual Management Review.
Now, does your company already have a system in place to track its strategic objectives? Very often, startup companies that we're working with are tracking their goals through systematic approaches like Gazelles, objectives and key results (OKR), or key performance indicator (KPI). Check if you can use those to also keep track of your quality objectives, by adding to or revising some of the things that are already in place. In our OpenReg templates, we propose to assign a KPI to each of your QMS processes, in order to meet a different 13485 requirement (they one to monitor and measure your processes, see paragraph 4.1.3). One again, here's some examples:
Now, does your company already have a system in place to track its strategic objectives? Very often, startup companies that we're working with are tracking their goals through systematic approaches like Gazelles, objectives and key results (OKR), or key performance indicator (KPI). Check if you can use those to also keep track of your quality objectives, by adding to or revising some of the things that are already in place. In our OpenReg templates, we propose to assign a KPI to each of your QMS processes, in order to meet a different 13485 requirement (they one to monitor and measure your processes, see paragraph 4.1.3). One again, here's some examples:
- CAPA: Completion of root cause analysis and definition of action plan within 1 week.
- PMS: conduct all post-market surveillance activities on time (100%).
- Purchasing: no purchases from suppliers that haven't been previously approved.
- Vigilance: report all serious incidents within the obligatory reporting deadlines (100%).
A minor upside of this approach: it's anyways your routine to constantly track your KPIs, they now just include quality stuff as well. And at the end of the year, your quality policy and objectives might stay the same (meaning, you don't have to update your quality manual). Instead, just update your KPIs, which are documented elsewhere.
In the end, you may end up with some KPIs that are strictly related to a QMS process, other KPIs that are generally quality-related, and some KPIs that aren't quality-related at all, but only relevant for your business interests. And that's totally ok! Just make sure, again, that you can explain to an auditor how your quality policy translates into quality objectives, and how each of those is tracked by at least one KPI. Imagine that your water cascade from earlier is extended by a third level.
In the end, you may end up with some KPIs that are strictly related to a QMS process, other KPIs that are generally quality-related, and some KPIs that aren't quality-related at all, but only relevant for your business interests. And that's totally ok! Just make sure, again, that you can explain to an auditor how your quality policy translates into quality objectives, and how each of those is tracked by at least one KPI. Imagine that your water cascade from earlier is extended by a third level.
On a different note: Do you need any help with your EU MDR efforts?
We've worked with 100+ companies and helped them certify their devices in weeks, not months. Talk to us now – first calls are free! Check out our services and prices here.
Or, if you don't like talking to humans, check out our Wizard. It's a foolproof, step-by-step video course for getting your compliance done yourself.
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Sven Piechottka
With a background in political and administrative sciences, my way into regulatory affairs started from a different angle. I focused on the promises of precision medicine during my final year of studies and first joined IBM to help leverage healthcare innovation projects across Germany.
I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.
I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.