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Showing posts tagged with: Cup of Joe

Cup of Joe #48 – qmsWrapper: messaging from home

Cup of Joe #48 – qmsWrapper: messaging from home

The Coronavirus (COVID-19) outbreak is creating a massive challenge for many businesses. Millions of people are taking refuge from the coronavirus by working at home. qmsWrapper does not see any issue when it comes to working from home. We are cloud-based QMS software, and it’s made to support continued team connection and business flow. It also...
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Cup of Joe #47 - 2 Risk Modules

Cup of Joe #47 - 2 Risk Modules

It’s always good to think a step ahead, and exactly that is what our Cup of Joe wants to tell you about. qmsWrapper is constantly working on improvements and keeps up with the changes in the market that considers Medical Device startups and manufacturers. The new MDR is set to become applicable in May 2020. One of...
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Cup of Joe 40# - Documents and procedures amendment

Cup of Joe 40# - Documents and procedures amendment

It's one thing to become ISO certified, but maintaining the certification is another thing with all the updates and new records. Besides following the processes and procedures that were set, it's also required to improve processes and all recorded as evidence. That means keeping up with your documentation, updating procedures when the processes change, modify work...
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Cup of Joe 34# - How to organize your folders?

Cup of Joe 34# - How to organize your folders?

Most of the startups and small companies have a problem with organizing folders, especially if they are still using a paper-based QMS. Where is this file? Is it under review? Is this draft version? Is it approved? The need to check it and review it, then approve can take time and mistakes can be weird...
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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?

Without proper employee training, business will likely see minimum success. Smart companies invest in the development of their employees. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.  Employee Training is deemed as the most important thing where the employees feel valued and develop an attachment to the overall mission of...
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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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Weekly Cup of Joe #25– Documenting Opportunities to Improve

Weekly Cup of Joe #25– Documenting Opportunities to Improve

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. MS Joe will guide you with handy tips & tricks to streamline your way to compliance.   The Relation Between Risk Assessment and Opportunities to Improve Companies often fail to...
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Weekly Cup of Joe #24 - Data Backup and Recovery Plan in QMS

Weekly Cup of Joe #24 - Data Backup and Recovery Plan in 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. Why Every Small Business Needs a Backup and Disaster Recovery Plan? Nobody wants...
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Weekly Cup of Joe #23– Corrective and Preventive Action (CAPA)

Weekly Cup of Joe #23– Corrective and Preventive Action (CAPA)

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.   Are Corrective Actions More Important Than Preventive Actions? Although CAPA is...
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Weekly Cup of Joe #22 – Risk Management Strategy in QMS

Weekly Cup of Joe #22 – Risk Management Strategy in 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.   Deer, Rabbits and Fast Snails, Risk is About Context Risk management...
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Weekly Cup of Joe #21 – References on Obsolete QMS Documents

Weekly Cup of Joe #21 – References on Obsolete QMS 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 will guide you with handy tips & tricks to streamline your way to compliance.   The importance of identifying and updating all the documents that...
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​ISO Audit and the Company Image

​ISO Audit and the Company Image

The Company must have a true picture of itself. It is not enough to possess the required information related to legislation, internal and external issues and interested parties, all this data should be properly documented, this information has to be available to the relevant project team members, who have to ensure the right policies are...
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Weekly Cup of Joe #19 –Projects in Wrong Place and Time

Weekly Cup of Joe #19 –Projects in Wrong Place and Time

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.   Determining Project Requirements Project requirements are one of the first things...
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Cup of Joe 18# - Why is it Important to Select Your Suppliers Carefully

Cup of Joe 18# - Why is it Important to Select Your Suppliers Carefully

Selecting suppliers is not an easy job for medical device companies. The pitfall is usually in the haste. It is really important to find a supplier whose objectives align with yours. Think strategically when choosing suppliers If the responsible employee has a very short deadline to evaluate the suppliers, they tend to simply accept the first offer they get....
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Weekly Cup of Joe #17 –Don’t Buy Pig in a Poke!

Weekly Cup of Joe #17 –Don’t Buy Pig in a Poke!

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.   Approving Documents with One Click Obtaining approval from a group...
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Weekly Cup of Joe #16 – Document Search Requirements in the QMS

Weekly Cup of Joe #16 – Document Search Requirements in the 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.   A properly designed Document Control and Management Chasing document traceability can...
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Weekly Cup of Joe #14 – QMS Documentation

Weekly Cup of Joe #14 – QMS Documentation

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.     How to put together a QMS documentation successfully? Properly structured...
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Weekly Cup of Joe #12 –Establishing the Quality Objectives

Weekly Cup of Joe #12 –Establishing the Quality Objectives

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 #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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