(This is me, next to my boat)
About 9 months ago I took up sailing as a hobby. Being near the water I thought it was a great way to get my head away from the office. Over the winter season I purchased a lovely old second hand dingy (a Miracle). The idea is that over the coming years me and my son can learn to sail together.
Last week was the first time I attempted to get the boat on the water. As a novice sailor I went through a check list in my mind on all the elements I needed to make sure the rigging and sails were all ready to go:
- Sails secure? Check,
- Main sheets ready? Check,
- Rudder attached? Check
So off I went onto the river Medway in Kent. The wind caught my sails, and I was off.
But then I realised the rudder wouldn’t stay down, and the bungs (the plugs that keep the water out) were broken and ineffective. So, I was effectively sailing in a boat without steering and sinking – not a perfect situation to be in!
Fortunately, I sail in a group of experienced sailors, with a safety boat close at hand to help. With their help I was safely towed back into shore when I can fix the boat. While this wasn’t a very positive experience it did teach me the importance of two things:
- 1.Do a complete health check of your boat before heading out, use a mental or written check list if possible,
- 2.Always reach out to other experienced people who can spot things you can’t.
The same 2 points are relevent to Quality Management Systems. If you have a new, or established QMS, whether ISO13485 or ISO9001, the way it is used will always change, continuous improvement is key to maintaining a safe and effective system.
IVDeology have an experienced team of Quality and Regulatory experts who can perform a Quality Health Assessment on your system. We can complete an independent overall system review against the relevent standard and regulatory framework (e.g. IVDR, MDSAP, FDA, UKCA) with an open and positive mindset to help you understand what opportunities you may have to improve your system.
Helping you understand the state of your Quality System now, will give you as best a chance as possible to navigate IVDR and UKCA transitions.
For more information on this contact me at firstname.lastname@example.org or book a video call.
Managing Director, IVDeology