Creating your own Quality System
Here are some tips for putting your own Quality System together!
Step 1
Get to know ISO/IEC 17025.
Conduct a gap analysis of your company's practices and existing documentation against ISO IEC 17025. You could use the NATA Assessment Worksheet as a template. A similar one exists for ISO/IEC 17020. Get your staff engaged with the process including identifying the gaps. When staff are part of this process, they are usually happy to be part of the solution!
You may find that you’re already well on the way to meeting the requirements.
Step 2
Decide how to address the gaps. ISO/IEC 17025 isn’t prescriptive about how the requirements are to be met so let your creativity flow and work out solutions that will work for your specific work context.
Keep documents as simple and easy to follow as possible. Remember that you want people to want to read them!!
Step 3
Draw all elements from the above steps into a formal 'system', traditionally this has been a Quality Manual.
Although a formal manual is no longer a requirement of ISO/IEC 17025, most laboratories find it helpful to document their processes in a centralised location. This is the skeleton that all other documentation hangs on.
You may choose to have stand-alone documents such as policies, procedures and work instructions or you might include all of these in the one document. Maybe a combination of both of the above is what works best for you.
Make sure that all quality related documentation is referenced in some way in the quality system. Don’t forget to include reference to the records that are being generated.
Step 4
Quality systems come in all shapes and sizes. There is no ‘right’ or ‘wrong’ as far as structure is concerned.
It is not a requirement that your system reflects the numbered clauses of the standard. Keep your overall goal in mind.
You want your documents to be read by staff and for them to actively engage with the processes. With this in mind, structure your system in a way that is clear and staff can easily find what they are looking for.
