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  • Where do you start if you need to create a comprehensive employee safety program from scratch? What can you do if your company is struggling with high rates of injuries and illnesses? These and other questions can be difficult to answer, particularly for companies in high-risk industries or without much in-house Environmental, Health and Safety (EHS) expertise. What many organizations don’t...

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  • The clock is ticking: in less than a year—February 28, 2019—previous ISO 13485:2003 certificates will no longer be valid. And if you plan to participate in the Medical Device Single Audit Program (MDSAP), that deadline is even earlier, as you’ll need to make the switch by the first of the year. If you feel like you’re behind schedule, taking concrete action can help eliminate some of the stres...

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  • Gartner’s five stage manufacturing maturity model helps organizations improve their manufacturing processes and supply chain management. This is especially important as organizations need a holistic strategy to build their existing capabilities to adjust to new initiatives such as Industry 4.0 and factory of the future. Adopting Gartner’s five stage manufacturing maturity model helps organiza...

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  • Americans waste 150,000 tons of food each day, which is the equivalent to a pound per person, says the Guardian. According to the article, research shows that people with healthy diets that are rich in fruit and vegetables are in fact the most wasteful. The article states that, fruit and vegetables require less land to grow than other foods but in turn, require a large amount of water and pesti...

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  • Disruptive technologies like ride-sharing, 3D printing and self-driving vehicles are driving rapid transformation across many industries. The Industrial Internet of Things (IIoT) is no exception, with manufacturing ripe for disruption due to the prevalence of manual processes. Given that human error is responsible for 85% of quality problems, it’s no surprise that roughly 1 in 4 companies who ...

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  • As of 2020, medical device companies that market products in Europe will be subject to a much larger set of requirements that mirror rigorous U.S. Food and Drug Administration (FDA) regulations. And while large companies have extensive resources to pour into complying with the new EU Medical Device Regulation (MDR), it’s not necessarily true for smaller companies. In fact, some experts predict...

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  • TechTarget defines an Internet of Things device as “any nonstandard computing device that connects wirelessly to a network and has the ability to transmit data.” The Industrial Internet of things (IIoT) has the potential to revolutionize manufacturing, not least of all when it comes to health and safety. What’s equally clear is that implementing IIoT is a huge undertaking, and not without its ...

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  • When it comes to ISO certifications, one thing companies can count on is a mountain of documentation. It’s especially true for certifying to ISO 13485 for medical device quality management, as medical device manufacturers must provide extensive documentation as evidence of the safety of their products—and the effectiveness of their quality processes. In today’s post, we’re examining ISO 13485...

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Blog Post
  • When it comes to ISO certifications, one thing companies can count on is a mountain of documentation. It’s especially true for certifying to ISO 13485 for medical device quality management, as medical device manufacturers must provide extensive documentation as evidence of the safety of their products—and the effectiveness of their quality processes. In today’s post, we’re examining ISO 13485...

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  • Total Quality Management (TQM) emerged in the 1980s in response to economic losses experienced due to Japanese manufacturers producing higher quality goods at lower cost. TQM was a natural outgrowth of the Toyota Production System, eventually giving rise to approaches like Lean Manufacturing and Six Sigma. Companies that adopt TQM and related process excellence methodologies need a specific se...

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  • Big changes are on the horizon for medical device manufacturers who market and sell their devices in Europe. On May 5, 2017 the European Union (EU) published updated regulations on medical device safety and quality, including the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). These new regulations represent the first major update to EU medical device standards i...

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  • More than 1 in 3 U.S. manufacturers are using smart sensors to collect and analyze data to improve their processes. The Internet of Things (IoT), which simply means connecting non-computing devices via the Internet, is rapidly evolving and shaping how companies do business. One of the most meaningful impacts IoT technology can have is in the realm of safety, helping reduce the 2.9 million work...

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  • If you’re just getting started as a quality professional, it can be overwhelming. If you’re unfamiliar with the industry, it’s hard to even know where to find guidance. To help you get started, we’ve put together some of the best quality and compliance resources we know.

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  • Training your employees should be more than just having them memorize processes and testing them on safety procedures. The latest developments in EHS training software for employees revolve around engagement and utilizing today’s latest technology. Tools like mobile devices and virtual reality have completely changed how managers can create effective and engaging safety training programs. Here...