Documenting your ISO IEC 17025 compliant quality system is not just a matter of 'writing' a quality manual. A well structured quality system will support your laboratory operations, not be a burden. The way that you document your system will affect how easily staff can engage with your quality system.

Step 1:
Familiarise yourself with 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. The NATA ISO/IEC 17025:2017 Gap Analysis is useful for clauses that are new to the standard following its revision. It also contains some guidance comments which may be helpful. 

It is highly likely there will be current practices in your laboratory that already meet the requirements of clauses in ISO/IEC 17025. The way to get staff to engage with your efforts to gain accreditation is to show them they are already halfway there and then get them involved in filling the gaps.

Step 2:
Once the gaps in your current system have been identified, determine how these gaps will be addressed. Where possible, design any new processes in such a way that they complement current practices as this will make implementation simpler (and get the relevant staff involved as they likely know what will work and what won't!). Document new processes where necessary and determine what records will be (or should be!) generated, bearing in mind the principle of traceability. Keep documents simple and easy to follow - remember that you want people to read them!!

Step 3:
Draw all elements from the above steps into a formal 'system', traditionally this has been a 'Quality Manual ('QM'). Although a formal QM is no longer a requirement of ISO IEC 17025, most laboratories find it helpful to document their processes this way. The QM is the skeleton that all other documentation hangs on. You may have a brief QM that refers to supporting stand-alone procedures and/or work instructions or you may include the procedures in the QM itself or have a combination of both. All documentation must be referenced in some way in the QM. Reference to required records must also be included.

Step 4:
Quality Manuals 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 QM reflect the numbered clauses of the standard. Keep your overall goal in mind. You want your QM/procedures to be read by staff and for them to actively engage with the processes. With this in mind, structure your QM in a way that is clear and staff can easily find what they are looking for.

Step 5a: 
​Pros and cons of a Quality Manual structure that is determined by clause numbers in the standard:
Pro- easy for auditors and easy to make sure you have addressed all the relevant clauses.
Con- usually not particularly user friendly nor do they necessarily reflect the flow of activities in your laboratory. Easy to fall into the trap of including meaningless clauses just to match the standard.
Risk- staff might not read it (or even worse, not follow it!!) 

Step 5b:
Pros and cons of a Quality Manual structure that is determined by processes:
Pro- encourages staff engagement and ownership.
Con- requires a more careful document review to ensure that all clauses of the standard are met.
Risk- auditor might not like it (but that’s their problem, not yours!!)

Step 6:

Make sure you audit your practices against the Quality Manual. Ideally it should be someone different from the person who wrote the Manual. Don't just audit but also take action on all of the findings to ensure that you keep improving.

The bottom line is to make sure your system works for you.

Your quality system is there to serve you, not the other way around!

If this all just seems too much, you can always give us a call. 



Keeping Quality Simple