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Showing posts tagged with: QMS

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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Weekly Cup of Joe #11 –The main focus of your QMS

Weekly Cup of Joe #11 –The main focus of your 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 is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to...
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Project management and quality management 2017 - smart solution

Project management and quality management 2017 - smart solution

qmsWrapper is 1 system with 5 modules   and if you thought project management couldn't include QMS... think again...    In a global environment, companies are facing countless complex and unique industry challenges. Quality becomes not just a buzzword but a true competitive advantage – companies that deliver the best quality products and services efficiently - succeed. Today’s QMS and...
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Weekly Cup of Joe #9 – Improper document, wrong results

Weekly Cup of Joe #9 – Improper document, wrong results

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 to streamline your way to...
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Weekly Cup of Joe #8 –  Ineffective task monitoring

Weekly Cup of Joe #8 – Ineffective task monitoring

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 to streamline your way to...
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The Dawn of Integrated QMS… Part 2

The Dawn of Integrated QMS… Part 2

qmsWrapper, the leading integrated QMS system specifically aimed at compliance  qmsWrapper has Compliance in its DNA. Since developed by a medical device company, the priority was to design a QMS application that solves many challenges facing medical device startups and small companies. Based on Project, Quality, Risk, and Document Management with a truly comprehensive Team messaging. In qmsWrapper,...
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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 Dawn of Integrated QMS… Part 1

The Dawn of Integrated QMS… Part 1

Making the life of a startup easier As regulatory and standards compliance increasingly play a critical role in business success, integrated compliance tools remain a sore point. QMS systems are too often based on PDF documents being generated at the right time. The challenge for the user is knowing when that time is, and what form...
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Weekly Cup of Joe #6 –  Identifying potential hazards

Weekly Cup of Joe #6 – Identifying potential hazards

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 to streamline your way to...
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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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Weekly Cup of Joe #5 – Incorrect Resource Management

Weekly Cup of Joe #5 – Incorrect Resource Management

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 to streamline your way to...
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Weekly Cup of Joe # 4 – Quality Planning

Weekly Cup of Joe # 4 – Quality Planning

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 to streamline your way to...
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Weekly cup of Joe #2 - Documenting Compliance

Weekly cup of Joe #2 - Documenting 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. qmsJoe is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to compliance. Simply...
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Risk as synonymous with uncertainty?

Risk as synonymous with uncertainty?

  ” Risk /rɪsk/, noun the possibility that something unpleasant or unwelcome will happen. Synonyms: chance, uncertainty, unpredictability, instability, riskiness…”   We’re dealing with countless risks in our daily life, like getting cut during apple slicing, or catching a cold if we get wet on a rainy day…or planning a project without a proper risk management plan…  Unknowingly you are doing...
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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 new software is straightforward, customer needs or use cases, requirements, specification, test...
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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 of...
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ISO 13485:2016 Summary

ISO 13485:2016 Summary

Medical Devices – Quality Management System – Requirements for Regulatory Purposes   The world’s most popular standard for medical device quality management has been revised for the first time since 2003: Medical Devices – Quality Management System – Requirements for Regulatory Purposes. The revised standard ISO 13485:2016 was published on 1st March 2016. It focuses on how companies...
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Management Through Quality, documenting compliance activities

Management Through Quality, documenting compliance activities

QMS, another layer of management or smart management.  If you’re thinking that a QMS system would be just another layer of management, think again! It’s true that most QMS systems are form-driven. Do an action, fill-a-form. Make a meeting, fill-a-form? The list is endless and if you forget, which is easy to do when deadlines are knocking...
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QMS Processes & ISO Compliance (ISO compliance in the business world and QMS processes)

QMS Processes & ISO Compliance (ISO compliance in the business world and QMS processes)

In a global environment, companies are facing countless complex, unique industry challenges. Quality becomes not just a buzzword but a true competitive advantage – companies that deliver the best quality products and services efficiently - succeed.     ISO certification, (be it ISO9001, ISO13485…)  communicates a commitment to quality to both customers and regulators. There are many benefits...
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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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