Quality Assurance
Quality assurance (QA) is the process in which you document internal processes that enable your product or service to meet specified requirements. These documents must be organized in a Quality Management System (QMS) – a platform used to establish and maintain the requirements for developing and manufacturing reliable, safe products.
The process and its many requirements can seem overwhelming, but it isn’t as complicated as it seems and doesn’t need to be so different from your current systems — let RAQA show you how.
Services – Quality Assurance
Establish QMS
RAQA can help you establish a Quality Management System (QMS) suited to your current and future needs. We recommend using an online QMS and have experience with many different online systems from our work with different customers. In our experience, there are many excellent online systems and we can help you find the one that best suits your needs.
See the Frequently Asked Questions section at the bottom of this page for recommendations.
Advising & Documentation
Once we have chosen a platform, we begin writing or tailoring your existing documentation to include all of the information required by the relevant regulations, such as approval routes, structure, etc.
We are available to advise you on Quality Assurance procedures and help write content to reflect your current processes, as required by the relevant standards and regulations. We can draft documentation or guide you through the process from start to finish. We have a pragmatic approach, creating a documentation framework that it can be finalized later in the process.
In addition, we can help draft Quality Agreements between you and your suppliers of raw materials, product components, or services like sterilisation, distribution or representation.
If you wish to be ISO 13485 certified, we can help you achieve this in cooperation with of our preferred partners.
Did you know?
ISO 13485 certification saves time
While the ISO 13485 certification is not a requirement under the MDR, the amount of time spent answering questions for the certification can make it worth completing. In addition, the whole approach to a Quality Management System is easier once you have done the ISO 13485 certification. You get used the process and, in the long run, save time looking for and establishing why specific decisions and choices were made – particularly 5 or 10 years later.
Think about the last important business decision you made. Will you be able to remember the circumstances and defend the decision in 5 or 10 years? Or if you leave the company, will the staff be able to tell why a deviation in a validation was accepted, but not documented, or why a product was not classified differently? Or will they be able to explain why a supplier’s replacement product for sterile packaging or data security was accepted and what the risk evaluation focus on, if it was conducted at all?
Completing the ISO 13485 certification takes time, but it gets you helps you establish a well executed Quality Management System, which in the long run, can save your company time and issues.
We can answer your questions and help you navigate the system, finding the best solution for your organisation and your clients.
Project Management
We offer Project Coordination or management in implementation of a Quality Management System. If establishing a Quality Management System and its related content is outside of your scope and current resources, we can help manage some or all of the process for you. We will ensure the process is completed professionally and efficiently.
By defining and implementing procedures, processes, and an online Quality Management platform, we help build a solid foundation for your future work. We create procedures based on your input and workflow, minimizing the amount of time and energy you need to spend on paperwork.
Audits
We offer resources to perform internal or supplier audits for your medical device company.
We can help with evaluating and qualifying suppliers as well as following-up on any pending issues.
Some companies prefer to have an external partner to cover supplier audits, especially when there are issues that need to be addressed.
Did you know?
Online Quality Management Systems have many automated functions and allow you to focus on what is important.
Many online Quality Management Systems offer a basic set-up specific to your branch. You will need to spend time adjusting the general content to your company, but it is easier than starting from scratch.
Online systems often have templates with several standards built into them in a practical manner, such as ISO 13485 and 14971.
There are also functions which make life easier, such as being able to easily enter metadata, transferring rights and responsibilities of a former employee, and adding a reviewer who can view the document’s archive and add comments.
Additionally, there is usually space for input and output data, allowing you to upload or drag and drop documents and allocated a reviewer or approver and deadlines. A email reminder is typically sent, if the assigned users don’t react in time.
These online systems make maintainting a comprehensive QMS much easier and more intuitive.
We can answer your questions and help you make an overview and plan the required submissions. You are in good hands with RAQA.
Mentoring
Let us explain requirements, suggest how to formulate content, and recommend approval routes for your Quality Management System. We are ready to teach you how to navigate Quality Assurance issues and understand the procedures. When you are ready to try it on your own, we are only a phone call away with support, encouragement and good advice.
FAQ
Frequently asked questions about Quality Assurance
What is a Quality Management System?
A Quality Management System (QMS) is essentially a library of the company's policies, processes, procedures, forms, and instructions that is carefully maintained to assist the company in managing quality.
The overall aim of a quality management system is to assist businesses in improving processes to ensure product or service quality and consistently meet regulatory and customer requirements.
What does a Quality Assurance Professional do?
A Quality Assurance Professional or Quality Assurance Manager works within regulated industries, such as medical devices, pharmaceuticals, construction, financial, amongst others.
Their primary goal is to guarantee product or service quality.
In the medical device industry, QA Professionals are often responsible for:
- Ensuring that the company and its current and coming products are in compliance with the relevant standards regulations
- Ensuring that processes are established, followed and updated when necessary
- Preventing product or process flaws by continual improvement of the processes and system
- Establishing platforms to control documentation by appropriate practices, including work flows
- Recording quality issues
- Collecting data and providing trending information
- Assisting with non-conformities and documentation of the investigation, method, results and effectiveness
- Employee training in QA protocol and processes
- Performing internal audits of the company and its suppliers
- Advising against poor or inappropriate decisions
In small companies, it is common that some or all of these tasks are outsourced.
Which are the main standards that are relevant for QA?
The main standards that are relevant for most medical device companies are ISO 13485, ISO 14791, ISO 15223-1, and IEC 62366.
For other product specific standards and national or regional specific standards, we recommend you search the internet for information, or contact RAQA for a consultation. With our many years of experience, we can help you determine which standards are relevant for your product in each of your desired markets.
Which online Quality Management Systems do we recommend?
There are many good online QMS systems. Recently, we have worked with:
- ins2outs.com
- D4infonet.dk
- simplerQMS.com
- Open Regulatory
There are also well known ones like:
- Qualio
- Greenlightguru
In addition, some companies use programs such as:
- Podio
- Sharepoint
- Excel/Word
In general, most of these are good systems, though we tend to recommend programs that are designed specifically as Quality Management Systems. Many software companies choose to build their own system, which can also be a good solution. Regardless of the solution you choose, we can help you optimize your system and populate it with the necessary documents. If you need help figuring out which system to use, let us have a chat about your products and desired markets. We can recommend a QMS that will best fit your needs.
Regardless of what you choose, we highly recommend that you ask for a demonstration of any system you are considering adopting. In addition, ask for additional discounts or features, like one month's free trial.
Which processes need to be documented in a QMS?
All processes, from the products conceptualization to its removal from the market, need to be documented and saved in the QMS.
Here are some useful guides focusing on the use of QMS in medical device companies: https://www.greenlight.guru/blog/iso-13485-qms-medical-device
Who can do Internal and Supplier Audits?
Typically, an employee or external contractor who has taken a course in auditing process and methods can perform internal or suppliers audits. The advantage of having an external contractor conduct audits is that they have no previous contact with the department or supplier and consider things from an objective point-of-view. Additionally, they can shed light on issues with existing processes and conflicting opinions.
Easy Medical Device has a useful blog post about internal audits: https://easymedicaldevice.com/internal-audit/
Are medical device QMS requirements different around the world?
The short answer is "yes". The requirements vary, especially with regards to reporting and language requirements. They may appear to be similar, but they often have a different approach or different required details.
RAQA can help you identify these differences and implement the necessary adjustments in your practices.
Why do I need a Quality Agreement with a supplier?
You need a Quality Agreement with suppliers to establish ground rules which reflect the requirements of the industry and business that you are in. The agreement can be simple and focus only on Medical Device Regulation requirements, product specifications and non-conformities, or can be much more detailed.
RAQA recommends that the Quality Agreement is always a separate document than the financial agreement, as they serve different functions.
Our Mission
To empower our clients by giving them the tools to navigate and comply with Medical Device Regulations in the EU and globally, so they can continue to successfully develop their products and businesses.
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