Quality professionals know the value of automation. Minimizing errors that lead to defects, freeing up internal resources and optimizing collaboration can all have a significant impact on your bottom line and brand reputation. These are all key benefits of automated quality management software.
Quality Creates Perspective
A QMS Resource for Quality Champions: news, perspective and commentary on hot issues in quality and quality management.
How To Map Your QMS To EU MDR Requirements
The EU's revision of medical device legislation was long overdue ... but what is the impact? Medical device manufacturers who are not up to speed with the latest European Union compliance requirements could find themselves struggling to catch up.
Avoid FDA Warning Letters with These 4 Document Control Best Practices
Incomplete records stuffed in the trash, with the signatures still showing. Blank forms issued complete with signatures. Employees shredding documents without bothering to record why and what they were destroying, even as inspectors were onsite.
4 Ways to Leverage Data for Operational Excellence
Data can be a gift and a curse when it comes to operational excellence. For some companies, ineffective practices make data a barrier to improvement, with too many data points and metrics obscuring the most strategic course of action.
Documentation Requirements in ISO 13485 – Start with a Quality Management System (QMS)
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.
Using the Quality Management System (QMS) to Support the 8 Principles of Total Quality Management (TQM)
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.
The Industry 4.0 Approach to Quality
Experts are calling Industry 4.0 the fourth Industrial Revolution (hence the 4.0). The concept represents a push towards manufacturing digitization that experts say will deliver massive improvements in efficiency, costs and profits in as little as just a few years.
Comparing ISO 9001 & ISO 13485 Differences Standards for Medical Devices
ISO 13485 for medical device quality management shares many similarities with ISO 9001, the leading global quality management standard with more than 1.1 million certificates worldwide.
5 Questions for Your Corrective Actions
Danish physicist Niels Bohr once said, “Every great and deep difficulty bears in itself its own solution. It forces us to change our thinking in order to find it.” Bohr’s work was instrumental in the discovery of the electron, an elusive subatomic particle whose location, even now, we can only describe in terms of a field of probability.
Employee Training Tips for a GMP Compliant Workforce
A proactive approach to employee training is the foundation to Good Manufacturing Practice (GMP) compliance. By creating a comprehensive, standardized program and keeping an eye out for common mistakes, companies can foster a proactive quality culture that prevents problems at their source.
Understanding the Basics of ISO 13485 for Medical Device Quality Management Systems (QMS)
ISO 13485 for Medical Device Quality Management Systems is growing in popularity, with the number of certified facilities jumping 13% from 2015 to 2016.
5 Steps of an Effective Corrective Action Plan to Ensure a Streamlined Process
When it comes to solving problems that arise in manufacturing, identifying the cause of what went wrong is top priority. But what about once you’ve pinpointed the root cause of the issue? That’s when the real work starts, and you have to make a corrective action plan capable of fully resolving the problem.
3 Types of Leading Indicators for EHS Management
You hear it all the time on Car Talk, the classic radio show where mechanics Tom and Ray (aka “Click and Clack”) dispense hilarious advice to clueless car owners. The caller’s car was smoking for months before breaking down. Or the driver taped over a flashing temperature light, continuing to drive her dad’s car until it died altogether.