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Services for Quality and Compliance
You should keep in mind that Quality and Compliance are both crucial components of the manufacturing process.
On one hand, if you aim for the high bar of quality, you'll get compliance. On the other hand, if you aim for the low bar of compliance, you probably won't get high quality.
If your employees don't have a culture of quality in place, then they may lose sight of how the devices they're building help the consumer.
However, your management team may focus too much on the budget and potential profitability. As a result, no one in your organization is focusing on quality.
Quality vs. Compliance
Quality is the condition and functionality of your product and it will determine how well your target market receives your devices. So, quality refers to more than just ‘quality movement’ techniques and practices.
Therefore, we need to make quality embraces your business excellence themes. Consequently, it will be easy for you to identify the need to integrate such tools and practices. This can be done with a quality culture that encompasses the elements of leadership, people-based management and customer focus.
Meanwhile, compliance is a set of rules and regulations that the FDA requires you to follow. In other words, compliance relates to conformity with all requirements.
As we can see, quality and compliance are certainly connected within your entire business. But, how can you create an organization culture that focuses on quality and compliance? It certainly requires the right training, mindset, processes, technology, and forward thinking.
So, how can you tell that your company is focused on quality, rather than only following regulations to meet compliance? In short, until you assess where you are, it will be difficult for you to know it and hard to move forward.
Here's how we can help:
Firstly, we will audit your current quality systems for compliance with government regulations, international standards, and internal procedures. Then, we will provide you with a detailed report, and most importantly, with a recommended corrective action plan that can be implemented by your team, our team, or a combination of both.
Secondly, we will ensure that your business is in compliance with relevant regulatory requirements.
Thirdly, we will provide you with the necessary tools to monitor and measure your business performance. Subsequently, we will identify and implement improvements.
Azimuth Compliance Consulting can provide your organization the guidance and training you need to reach your quality and compliance goals.
First, you should decide which path to follow. iBPM technology is where your journey begins.
Your Options: