This is a blog written by Elemed expert guest blogger Kenn Milton.
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In this blog, we will discuss why you should want a Quality Management System, even if you do not need one.
They are two reasons for implementing a Quality Management System:
– To run an effective business
– It is a requirement
“Quality” gives Management Systems a bad name!
If you, or someone you love, was the patient, of the device you are manufacturing, what would be your own minimum expectations to be met by the manufacturer? Would you, as a minimum, expect that the device was tested to be safe and work as intended, and know you could get help if required?
Quality is the minimum expectation of any patient or customer paying for a product or service. How can it be that when the word “Quality” is mentioned inside a manufacturer or organization, it makes people run for the hills. Shouldn’t good quality be the top priority of any manufacturer in any industry? We are working in an industry where quality is essential for devices to be safe and effective – so why is quality not first in mind, when introducing new innovative products to the market?
We are so fortunate, that experienced organizations have already defined what is required to deliver quality products to the market. It is true that some companies have been interpreting these directives in a way which resulted in harming patients, which in turn requires for the requirements to be strengthened. As an example, this new regulation introduces the need for an increased number of companies, to implement a Quality Management System.
Setting up a system for quality should be the first priority and minimum expectation for any company that wants to go from a hobby project to a professional business. Your customers expect you to run a professional company, no matter if your customer is a lay person, healthcare professional or a business.
If you want to run an effective business, you will need to introduce a set of procedures, that will help onboarding new personnel, harmonize processes, avoid rework, and ensure a uniform output. If there is a possibility to enhance these procedures to work even more efficiently, then it should be considered. It will make better use of available resources. This is simply good business practice.
You should author a procedure for any process in the supply chain that you are doing. When you need to author a document is it important to have a Document Management procedure. If you are doing any work in a GxP (regulatory) environment, you must be qualified for your role, according to a Training Management procedure. For Risk Management you need to have a Risk Management Procedure. This is to ensure, that all personnel are following the same processes. It just makes a lot of sense.
When you are in control of your business you can put “Quality” back into Management Systems, and you will be meeting the ISO requirements and Regulatory Requirements. Quality Management System is nothing but ensuring that you are running an effective business while ensuring general safety and performance requirements.
For how long can your company key resource be away from their job before it impacts your business? 1 day, 7 days, 1 month? What if your key resource leaves your company, how do you ensure that all the knowledge remains in the company? Knowledge sharing and Document Management should be the minimum requirement to ensure that information is captured. When sharing information, you should have a controlled mechanism for storing and updating information. If you just learn to store documents, use version control, and share documents through a controlled storage area, then you are already covering 80% of the expectations in a Quality Management System.
I do not need one!
It is typical that smaller companies think it is too early to implement a quality management system, as “they are still in the innovation phase”. Another concern is that only larger corporations can afford to have a Quality Management System. However, now it is possible for the smaller companies to work better and faster. When the requirements are known in the beginning of the project, it will save yourself from a lot of grief and heartache. When you send the first email with a document review or you have been working in the same project for more than one month, you could already have benefited from having a Quality Management System. When you are discussing the device intended use, description, and initial design, you should already think about what the correct details to consider are.
Even if you are manufacturer of a Class I product, you will need to create a Technical File. The technical file must include requirements, testing, and you will still have obligations in a Post-Market scenario including collection of incidents, complaints, reporting of serious adverse events and making CAPAs. The EU declaration of conformity and the technical file must be available upon request for 10 years after the last device has been placed on the market. It can seem obvious that even though an electronic document management system, with version control and electronic signature is not required, it might be of help to introduce one.
Learn from people who have done this before.
If this is the first medical device you are producing, you might be in the prototype phase, until someone is kind enough to remind you that you need a Quality Management System to be able to continue into Clinical Investigation. If you are on this journey for the second or third time or more, you already know that a Quality Management System will also help you minimize rework and focus on what matters.
Why should you want one now?
You should know the end before you begin. If you know the requirement before you begin your journey, chances are that you are not doing any unnecessary extra work, which is no value add. Time is ruthless and is not going to slow down because you went down the wrong path. Stay focused and goal-oriented.
Quality By Design
You need to find a solution, which makes you run an effective business. If the quality management system activities take away all your creativity or time, you might need to think about getting a new system in place. If your quality management system, does not help you to focus on what matters, you need to find a new system. You need to find a system which is easy to onboard, easy to use, and when using it, quality is enabled by design.
Medical Device Regulation
The Medical Device Regulation, MDR will be enforced in May 2021. In this regulation, new classification rules are introduced. It is essential to establish the correct risk class of each individual device with classification rule(s) in accordance with MDR, Annex VIII – Classification Rules. A Quality Management System, which is appropriate to the risk class, is required, by medical devices risk classes above Class I. The minimum requirements expected for a Quality Management System is listed in Article 10(9) – Obligations of the manufacturers. Furthermore, the ISO 13485 – Medical devices — Quality Management Systems details the requirements on how to implement and maintain a Quality Management System for Medical Devices. Risk Management and Post-Market Surveillance activities and tracking of the two, are in focus. Therefore, it makes sense to look for a Quality Management solution where it is possible to register and track the risks and opportunities in each supply chain step against reported incidents, while ensuring the MDR, Annex I – General Safety and Performance Requirements are met.
The recommendation is, to get some help to start the journey right. Do regular reviews to ensure processes are effective and technical documentation is relevant. In the end, a Quality Management System is a business advantage.
1. Medical Device Regulation, (EU) 2017/745
2. ISO 13485:2016 Medical Devices – Quality Management Systems
3. ISO 14971:2019 Medical Devices – Application of Risk Management
About the author
Founder and CEO of MyBlueLabel
Kenn is working with large corporations about innovation within Enterprise Risk Management solutions. He is a focused and result-oriented Senior Executive, with significant experience in the provision of compliance solutions. A competent strategist, capable of delivering innovative solutions to ensure seamless project delivery and the achievement of business objectives. Kenn ensures full compliance with internal and external regulations and quality processes. For several years, he has been developing a SaaS solution based on the Quality Management experience carried by a strong wish to help all companies with Quality and Risk Management.
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