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 realize the relationship between “Risk Assessment” and “Opportunities to Improve”. For QMS Beginners, Risk Management means activities related to hazards that may result in some kind of negative impact on the project.

However, Risk Management covers more as defined in both ISO13485 and ISO9001. One of these requirements is “Opportunities to Improve”. The ideas for improvement (be it related to company processes, project development, product manufacturing, etc.) could come not only from risk assessment but from different sources such as brainstorming meetings, past experience, analyzing competitor’s products, customer feedback, etc., there is no limit except to your imagination. The goal is to find sources of ideas for continuous improvement.


If it’s not documented, it does not exist a.k.a. Spoken words fly away, written ones stay

Documenting improvements are more important than the ideas itself because an idea that is not documented, does not exist. Not just because even brilliant ideas might get forgotten easily but also because it is a compliance requirement of many standards.

qmsWrapper provides an effective and easy to use solution for documenting your ideas so they are not lost opportunities to implement improvements in the future.

  • Through the built-in chat communication tool, with separate topic-specific chats, employees can share their ideas and comments. Topic-chats can be reviewed by the relevant personnel and ideas, commented on, approved or declined, and even saved to minutes for a more formal record.
  • The meeting minutes include the outlines and important details that can help in guiding improvements through to implementation by attaching tasks to individuals and even creating an agenda for future follow-up meetings on specific issues. It’s never been so easy to follow-up using chat.

Cup of Joe: Documenting Opportunities to Improve

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