Showing posts tagged with: QMS
Choosing a QMS system? Why you should seriously look at the new qmsWrapper!
The new version of qmsWrapper is updated in December 2019.
We were still shaking from a disastrous ISO audit. Joe, the perennial QMS manager from Jurassic times, just have been fired. Even though he liked pushing the paper-based system, a medical device company has too many regulatory pitfalls to trip you up. Brilliant engineers and developers just...
Weekly Cup of Joe 29# – Customer Feedback is a Wealth of Information
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.
Improve Customer Retention and Ensure That You Keep the Finger on...
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 include)
Common mistakes in establishing a QM, and how to avoid them
Pro...
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...
Ultimate Tips and Guidelines to Fine Tune Your Employee Trainings
Tips and guidelines to create an efficient workforce and keep your business functioning at a high level. (ISO 9001, ISO13485, FDA510K)
Nobody wants to hire a person that is unable to do a job to a satisfactory standard. This is especially true when it comes to QMS related functions and activities. Besides, the candidate’s adequate competency...
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...
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...
The Quality Manual F.A.Q. – Quality Manual Writing Tips
To pass a certification body audit, a Quality Management System must be an auditable entity with a neat Quality Manual.
How to get useful ‘written stuff’?
For hints on what to do, see the Quality manual writing tips part 2, in this short and clear infographic we collected 13 of the top F.A.Q.s and answers.
If you want...
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...
What if staying ISO and FDA compliant was easy?
In the previous article, we 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...
The Quality Manual Alias the Quality Bible or the Quality DNA
Document what you do and do what you document
Quality Manual is the foundation and framework from where you build your organization. It is a plan, which sets the direction and navigates the organization within the defined parameters. Like any plan, it is good to revisit once in a while and check against the agreed objectives,...
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...
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...
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...
Advantages of Cloud Based QMS and Project Management Software
Advantages in numbers
Every industry or organization is working hard to achieve success and to ensure their service and product safety. Nowadays, it is hard to imagine the work without an electronic, cloud-based QMS or project management tool.
Cloud-based tools are the most searched software today, they are easy to obtain through the internet, they are flexible,...
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...
The Purpose of a Quality Management System
Small businesses typically face a struggle to succeed in a competitive MedDev marketplace. Companies that offer quality services or products are better positioned to not only survive but prosper. A well-managed QMS is paramount to success.
What is a good Quality Management System?
QMS systems come in all flavors and shapes, some are industry-specific, others more general,...
Approval Workflows in QMS
Issues in approval workflows
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...
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...
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...
Weekly Cup of Joe #15 – Quality Manual or Company Processes / Chicken or The Egg
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.
So, what documentation hierarchy should we adopt?
This question is a...
QMS documentation - “What should I document?”
Good QMS documentation is essential for an effective quality management system. Properly structured documentation will make your operations much easier, while incorrect documentation will bring you nothing but trouble.
Use qmsWrapper to structure your QMS documentation, follow the necessary steps and avoid those unpleasant last-minute surprises.
What has to be included in a QMS Documentation, regarding ISO?
Usually,...
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...
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...
Weekly Cup of Joe #13 – Strategy for Achieving 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...