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Showing posts tagged with: standard compliance

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 #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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Are companies ready for the ISO 13485:2016? “a closer look”

Are companies ready for the ISO 13485:2016? “a closer look”

Surprisingly this is a real and topical question. At every MedDev or MedTec oriented exhibition this is the off-stage topic, actually more like main grippe session. The 2016 version requires a lot more emphasis on risk management and embedding risk management into the quality system processes. But really there are two issues in play with respect...
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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 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 #7 - Vague wording

Weekly Cup of Joe #7 - Vague wording

Vague wording used in requirement documents 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 is here to guide you through the plethora of information and support you with handy tips & tricks...
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The Temptation of ISO 13485 Template Kits

The Temptation of ISO 13485 Template Kits

Be careful what you use when building up your QMS system! The expanding Internet means more: more data, more collaboration, and more complex systems of interactions. You can find hundreds of both expensive and free templates for ISO 13485, offered by various consultants, companies and experts. But even if the ISO compliance is guaranteed on some...
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6 Benefits of ISO Compliance

6 Benefits of ISO Compliance

ISO’s standards are created to guide companies in dealing with some of the most demanding challenges of modern business – Quality & Customers. At its core, the ISO system is underpinned by the pursuit of recognizable quality that ties business goals and customer needs. The aim is to make business operations as efficient as possible...
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7 Easiest Ways to Create a Championship Team Through Collaboration

7 Easiest Ways to Create a Championship Team Through Collaboration

“Individuals play the game, but teams win championships” Bill Parcells As in sport, the same rules apply to business. Collaboration is the glue that binds teams. Collaboration is different people executing together on the same issues, cooperatively whether communicating through Chat, Voice, Video or email. But when the business involves regulatory and ISO compliance, collaboration also relates...
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QMS Manager: Job or Role?

QMS Manager: Job or Role?

Diving deeper into ISO 13485:2016 meeting roles, defining them as the ISO standards and regulations expected from us, we can get a headache of how to define QMS management. Is it a job or is it a role in an organization?  A QMS manager is a one-person Job with a very critical role, so we recommend...
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Email is a Team Killer

Email is a Team Killer

Your email address is the proverbial key to the internet. No email address, no account at Facebook, no streaming, no whitepapers, no downloads. Whether you use Gmail, Yahoo, AOL or a host of others, you need an email account because it’s your ID on the web; after all, “You’ve Got Mail”. If you don’t need an...
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