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Showing posts tagged with: QMS best practices

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Pitfalls and Best Practices in Establishing a Quality Manual

Pitfalls and Best Practices in Establishing a Quality Manual

It takes the same amount of time and effort to create a good quality manual as it does a bad one. Oftentimes, far less... In this article, we will discuss how to establish, operate and maintain a good one: Introduction (what is a QM, and what should it include) Common mistakes in establishing a QM, and how to...
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Weekly Cup of Joe #28 – Is Employee Training Worth the Investment?

Weekly Cup of Joe #28 – Is Employee Training Worth the Investment?

Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.   Convert Employee Training into the Workplace Don't try to save money on...
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Validating or Not Validating for Intended Use?

Validating or Not Validating for Intended Use?

When I say Validation For Intended Use, most of you picture an extensive documentation required by ISO and FDA. Although Validation for intended use documentation is useful for several reasons (ensure accuracy, reliability, consistent intended performance, the ability to discern invalid or altered records, etc.) people mainly think of it as a regulatory requirement only. In FDA's...
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Weekly Cup of Joe #27 – Validating With The Wrong Requirements

Weekly Cup of Joe #27 – Validating With The Wrong Requirements

Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance. Validating your system for FDA and ISO Both FDA and ISO13485...
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Weekly Cup of Joe #26 – Advantages of An Integrated PM and QMS

Weekly Cup of Joe #26 – Advantages of An Integrated PM and QMS

Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project... your strategy requires QMS oversight. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance. Bolt-on Quality Management Apps, put the cart before the horse The mistake...
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What if staying ISO and FDA compliant was easy?

What if staying ISO and FDA compliant was easy?

In the previous article, I took a closer look at ISO13485:2016 and the pending doomsday scenario. In this article, I’ll take a closer look at the similarities between ISO 13485:2016 and FDA QSRs. Similarities between ISO 13485:2016 and FDA QSR A quick reality check of ISO 13485:2016, reveals that it actually looks more, smells more and sounds...
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ISO 13485 – 2016 Checklist

ISO 13485 – 2016 Checklist

A checklist on where to start, and what to do first   Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project, you’re reading this because your strategy requires QMS oversight and your first question is likely “where to start” and “what...
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Approval Workflows in QMS

Approval Workflows in QMS

Achieving and maintaining compliance is not an easy job as both ISO and FDA regulations require that documents be approved before they are officially distributed or used either inside or outside the company. Obtaining approval from a group of people for a project plan, a proposal, or any other required document can be a frustrating...
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Quality Manual or Workflow Processes? What should I establish first?

Quality Manual or Workflow Processes? What should I establish first?

  So, what documentation hierarchy should we adopt? It turns out that this question is a classic for a reason. People have been asking it for many years, and there is more than a little confusion on the answer. The Quality Manual requires many references to the applied company and the workflow processes. Synchronously, most quality management related...
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QMS for Beginners – A quick guide on where to Start ! …Part 4

QMS for Beginners – A quick guide on where to Start ! …Part 4

  12. Customer Support and Life Cycle management Customer support is not the issue at this time. You need to develop and finish your product first, then get it cleared through FDA and CE Approved. You need a system that’s focused on those issues. Don’t get confused by these future requirements. There is time enough to figure...
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QMS for Beginners – A quick guide on where to Start ! …Part 3

QMS for Beginners – A quick guide on where to Start ! …Part 3

  The 13 items that will guide you through the implementation of QMS ...Let's pick up where we left off !   8. Selecting the right system to support your Compliance Compliance Solutions are essentially QMS based solutions. They come in all shapes and sizes. Some solutions, such as ZenQMS are nothing more than forms tacked on to a project management...
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QMS for Beginners – A quick guide on where to Start ! …Part 2

QMS for Beginners – A quick guide on where to Start ! …Part 2

  The 13 items that will guide you through the implementation of QMS - continues...   4. Organizing the work Next you will need to define the flow of how work gets done within your organization, i.e. the workflows. Why, because you need to understand where compliance issues will fit in. Workflows can show you the path tasks take through your organization… i.e....
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QMS for Beginners – A quick guide on where to Start ! …Part 1

QMS for Beginners – A quick guide on where to Start ! …Part 1

Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project, you’re reading this because your strategy requires QMS oversight and your first question is likely “where to start” and “what to do”.   We could squeeze in 5 main points the initial...
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Weekly Cup of Joe #3

Weekly Cup of Joe #3

Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project… your strategy requires QMS oversight. qmsJoe is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to compliance.   Monitor...
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Chat for Compliance – a hacker’s view!

Chat for Compliance – a hacker’s view!

This week we bring you a real-life experience example about how the qmsWrapper built-in chat function can turn the compliance documenting process into an easily manageable one. The ongoing quest for compliance can sometimes be challenging when the needs are not always clear. For example, developing a new software is straightforward, customer needs or use cases,...
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Weekly Cup of Joe #1

Weekly Cup of Joe #1

What's the first step towards FDA or ISO compliance ?  Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project… your strategy requires QMS oversight and you have several questions like “where to start” and “what to do”. There is a lot...
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