The creation of a Quality Management System is always a challenge for companies that want to sell medical devices. The Medical Device industry is highly regulated and having the right system is important to be sure that we provide the right product to the customers.
But one issue that always happens is the fact that companies think that it’s only a question of documentation. “As soon as the documents are ready, then we can get certified”
The answer is NO and we will help you understand that.
To define what is the best process to create a Quality Management System, I asked Jason Lim from Stendard.io to help us. He accepted to get interviewed on my Podcast and I tried to summaries the discussion on this blog post.
If you prefer to see the interview check the video below.
Don’t miss also the offer provided by Jason in case you are interested in his solution. The coupon code is “EASY10” for a 10% discount.
And to be more specific to the EU MDR 2017/745 and IVDR 2017/746 requirements, I also released an episode with Stefan Bolleininger on “Creation of a QMS compliant to MDR”.
Check both episodes to help you build your QMS.
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Table of content
What is a Quality Management System and why is it so important?
Basically a QMS is a set of processes and procedures to confirm that the company delivers the right products consistently.
This is important for any company but being a Medical Device company it is even more important to have a good system. Imagine that you send your products to patients in hospital, this would be unforgivable if there are some inconsistencies in the way it is performing.
Let’s take the example of blood pressure meter. This is supposed to be measuring the blood pressure of a patient. But if this is inconsistent, then you have a patient getting the wrong measure which leads to wrong treatment. If this is for example your family member that is the patient, would you accept that?
This situation is critical for the patient but also for the healthcare professional that is looking for guidance on what they should do.
A QMS will help to organize the deliverable of your company and be sure that all is compliant to the requirements.
Are procedures enough to have a good QMS?
A QMS is here to lay down the processes and how to execute them. To confirm that you have a good QMS, an auditor is appointed and will review it. This is sort of an exam.
Some companies are considering the QMS as just a formality to satisfy the auditor and be able to sell products. And some others are really considering that as a tool to help there organization to grow and satisfy his customers.
I would really convince you to follow this second path. I know that your first objective is to sell your Medical Devices and start to make some money, but procedures are not enough to have a good QMS. The culture and attitude you will have towards the QMS will also be capital for the future of your organization.
Different types of QMS standards
You should now decide which Quality Management System you should use. There are many available for many types of industry.
For example, for the Food industry or for aeronautic… On this article, we will take the example of the Medical Device industry but the different advise provided can also work for any other industry.
Below is a non-exhaustive list of some of the QMS that exist:
- ISO 13485:2016
- FDA QSR 21 CFR part 820
- Food ISO 22000
- ISO 14000
- ISO 45000 replace OHSAS 19001
- Cybersecurity: ISO 27000
If you are selling your products to Brazil, USA, Canada, Australia, Japan, then you should also consider MDSAP.
This is a certification that is helping you to be compliant with multiple countries. Check this article with a lot of details on how to succeed an MDSAP audit.
5 Steps process
The Process to create a QMS is a bit fuzzy. There is no real control and transparency on where to start.
This is difficult for companies when they hire a consultants to know what those are doing.
To help you, Jason Lim identified 5 steps to navigate through this project. These 5 steps will give you the fundation for the QMS building. If you miss one of those step, your project will be at risk.
Step 1: Documents creation
Write your procedures that will be part of the QMS. You can start by looking at the chapters of the ISO or other standards to see what are the requirements.
For example, with ISO 13485, there is a requirement to create a Quality Manual, a procedure for CAPA… All is written inside. So go chapter per chapter to understand the requirements.
If you don’t know how to write a procedure, I suggest you read this post where I provide you with a template.
But don’t block yourself when you are writing your procedures.
What does it mean?
This means that sometimes, we try to be too extreme on the content of a procedure. This is not helping but creating more problems. So please just use the quote below.
My challenge: Create a QMS in 30 Minutes
Step 2: Training
You need to train your employees to the procedures. To execute their work, they need to use them but also they need to prove that they have been trained on them.
The auditor will ask you to provide evidence of this training. Without that, the auditor will think that employees are executing some activities without to follow the Quality Management System.
So, build a curriculum for each employee with all the procedures that they should be trained on.
For each training, get a system or proof that this was executed. You can also implement a Quiz for your procedures to check if the employee understood it.
All this would be great evidence that your employees are trained.
Step 3: Document implementation
You have created your documentation and trained your employees, so now the next step is to use your Quality Management System.
This is an important step as you should show that the system is working. Because an auditor will need to see some evidence that your system is properly functioning, stable and that all your employees understand it.
For example, for the CAPA system, the auditor will try to evaluate one CAPA and if you have none, this can be a problem.
Some things that you should have before your first certification are:
- An internal audit executed
- A Management Review Report
- All training of your employees
- Agreements with your suppliers
So you see that the procedure is not sufficient. You should use them and provide some documentation as an output.
Step 4: Internal Audit
This a pre-exam before the real one with the third party (Certification body).
This session is important. The company should appoint an internal auditor (internal employee or external consultant), to review the processes.
I call it a Crash-test when this is the first time the company is experiencing that. This is good or bad so you cannot just say this will maybe work.
My advice is to make it correctly and try to find issues before the certification body auditors.
There are multiple types of audit that are existing for a Medical Device company. I described them on this article.
In small companies, it is usually only an Internal audit. But if you are a supplier, you can also get Customer audits. And is you are part of a big corporation, this is a Corporate audit.
So there are many ways for you to see if your Quality Management System is compliant.
Step 5: First Certification
This step is critical as if you don’t succeed on it, you’ll not be able to manufacture and sell your Medical Devices. This is your final exam.
If you followed Step 1 to Step 4 you should be in good shape to get certified. But, you also need to understand how to behave during an audit as there are some rules to respect. You can read this article to get some idea.
Basically, the auditors will come and sample your system to review your documents. As they will stay a few days, they will not be able to review everything. Your job during this time will be to provide them with all the evidence to prove that you are compliant to the concerned standards.
In the end, you can still have some small issues and then get some non-conformance. What I hope is that this will be minor issues. But don’t argue against them if they are valid.
Remember, this process is a journey so you will have many years to improve and show a better system year after year. Usually, you’ll get the same auditor for 3 years so he will be able to see the progress.
Below is a case study explaining to you the workflow of an audit.
QMS compliant to EU MDR
For your Quality Management System to be compliant to EU MDR, there is one thing to do. You need to check that all elements listed on Article 10(9) of EU MDR 2017/745 are incorporated into your documentation.
To help you I copied the list from the article 10 below. So if your procedures contain all this then you are on the safe side.
But additionally, there are some requirements listed on Annex I – GSPR
And also some requirements listed on the Conformity Assessment annexes.
Below I also included the Podcast Episode done with Stefan Bolleininger from Be-on-quality where we tell you more about the compliance of your QMS to EU MDR.
The quality management system shall address at least the following aspects:
a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;
identification of applicable general safety and performance requirements and exploration of options to address those requirements;
responsibility of the management;
resource management, including selection and control of suppliers and sub-contractors;
risk management as set out in in Section 3 of Annex I;
clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;
product realisation, including planning, design, development, production and service provision;
verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29;
setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83;
handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;
processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;
management of corrective and preventive actions and verification of their effectiveness;
processes for monitoring and measurement of output, data analysis and product improvement.
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The creation of a Quality Management System is critical. You have many solutions to have one as:
- DIY: Do it Yourself
- Get support from some softwares
- Hire consultants
But one thing is clear, you should then test it before to engage with a certification body. You need to be sure that this is working, as all the documents that will be created will serve as a proof to the auditor.
If you need some support for the creation of a Quality Management System, don’t hesitate to connect with me so I can guide you on your journey. Just click on the bubble below.
Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don’t hesitate to contact him at firstname.lastname@example.org or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.