As a Quality Management System (QMS) we define a formalized system of a company’s processes, procedures, and responsibilities, in order to achieve quality processes and objectives. A QMS is focused on meeting customer and regulatory requirements and, thus, improving its effectiveness and enhancing the customer’s satisfaction.
In this article, we will focus on companies operating in the field of medical devices as well as how they can achieve quality management certification.
Benefits of a Quality Management System
The implementation of a quality management system will have an impact on every aspect of a company’s performance. The benefits of such a system are the followings:
- Meeting customer requirements, which boosts the company’s confidence
- Meeting organization requirements, ensuring compliance with regulations
- It helps the companies to define, improve, and control processes
- Reducing waste
- Preventing mistakes
- Lowering costs
- Facilitating and identifying training opportunities
- Engaging staff
- Setting organization-wide direction
- Communicating a readiness to produce consistent results.
Types of QMS Standards
There are several types of Quality Management Systems, though the most commonly used and referenced types are the ISO standards. The reason the ISO standards are the most widespread is that they manage both quality and sustainability and where these two meet. The most common of these standards is the ISO 9001, a standard that companies within all industries seek and achieve. In the table below you can see other accreditations and the industries, they’re most applicable to.
|All industries||ISO 9001:2015 Quality management systems — Requirements|
|Automotive||IATF 16949:2016 Automotive Quality Management System|
|Medical device||ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes|
|Food||ISO 22000:2018 Food safety management systems – Requirements for any organization in the food chain|
|Services||ISO/IEC 20000-1:2018 Information technology — Service management — Part 1: Service management system requirements|
|IT||ISO/IEC 27001 Information Security Management|
|Aerospace||AS 9100D Quality Management Systems – Requirements for Aviation, Space, and Defense Organizations|
Elements of a QMS
When choosing a Quality Management System you have to determine your organization’s unique needs. However, there are some key elements you have to cover before achieving a quality standard, no matter the industry you operate in. Each one of these elements will help you achieve your overall goals and meet the customer and organization requirements. The common elements for all systems are:
- The organization’s quality policy and quality objectives
- Quality manual
- Quality procedures, instructions, and records
- Quality data management
- Internal quality processes
- Customer satisfaction from product quality
- Improvement opportunities
- Quality testing and analysis.
Why QMS is important for a company
As a business that wants to improve its operations and be able to meet customer and organization requirements, you should consider achieving a Quality Management System. If you’re not comfortable with implementing a QMS by yourself, you could always outsource the management of your processes. Either way, a QMS will help you remain compliant with all the latest regulations and standards.
Establishing and implementing a QMS
The implementation of a Quality Management System can be really difficult because of the requirements each system has regarding the business, the processes, and the people working in it. However, keeping in mind that the QMS should be based on your organization’s objectives, needs, and products or services you provide, things could get a lot easier.
The structure to implementing any Quality Management System is as follows:
- Design and build, it’s the first phase of the implementation where people from the business come together and organize the processes for the management system,
- Deploy, by the time you’ve reached the second phase it means that everything has been planned out,
- Control and measure, it involves internal and external audits, inspections, and check-ups on normal operations, and last,
- Review and improve, during this phase you examine/analyze the results of audits and from tracking tools in order to understand how you’re doing/performing, so you can make the necessary improvements. Once you complete the fourth phase, the cycle starts again.
When to implement a QMS
As a medical device company, you are required to have a Quality Management System (QMS) in order to be compliant with regulations and meeting the customer and organization requirements.
The three most common markets that we witness medical devices get launched in are the US market, the Canadian market, and the EU market. These three markets have a similar regulatory requirement, that of implementing a QMS before placing the product on them. Each one of these markets has its own respective regulations. For the US market, the FDA upholds 21 CFR 820, for the Canadian market is valid the Health Canada’s Medical Device Regulations (SOR/98-282), and the EU market requires compliance with the Medical Device Regulation (EU 2017/745).
The most effective way to be compliant with QMS requirements for all three regulations is by establishing ISO 13485. If you make the necessary changes to it you have a tool that will help you in all three markets.
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