Now that the ISO/IEC 17025:2017 standard has been published, laboratories can start working on the first step towards updating their management system - a gap analysis.
The concept of a gap analysis is fairly straight-forward. A gap analysis is a useful technique that you can use you to identify the gap between your current management system and the revised management system. Part of conducting the gap analysis is determining the tasks that need to be done to close the gap.
The first step in any gap analysis is to identify the 'future state.' In other words, what does your management system need to include to conform to the new requirements. In order to determine this you will need to become familiar with the revised ISO/IEC 17025 standard. CALA Training can help with that. Check out the courses on the new standard by clicking here.
When doing the gap analysis you should also consider whether the future state of your management system includes other changes not necessarily related to the meeting the requirements of the standard. Are there any deficiencies in your current management system that you want to address at this time? For example, changing how your policies are written, or putting your quality manual or other management system documents online. If this work is going to be done as part of the update of your management system, then include these details in the description of the future state of your management system.
The next step in the gap analysis is to analyze your current situation. What is currently included in your management system documents? You may need to consult other people in your laboratory to get an accurate picture of what is included in the management system documents and if there are any additional changes required. Make note of what information you need and who you will be getting this from.
The third step in the gap analysis is to compare the future state of your management system to the current state and develop an action plan to make the changes. The typical format used for a gap analysis should work well for this step. For example:
|New requirement||Current state||Deficiency||Action Plan|
|4.1.1 Activities undertaken Impartiality||Covered in QM 3.2||Does not cover how lab is structured to safeguard impartiality||Review and update the policy.|
4.1.2 Lab management committed to impartiality
Once your gap analysis is complete, you can use it to develop your plan for updating your management system.
Don't forget to also develop a communication strategy so everyone in your laboratory understands the changes being put in place, and they have an opportunity for input, where applicable.
For more information on Gap Analysis, check out the webinar - Gap Analysis as a Tool in the ISO/IEC 17025:2017 Transition.
To train your staff on the new ISO/IEC 17025:2017 standard, check out CALA's courses, or contact us about having an on-site course for your staff at email@example.com or by calling 613-233-5300 x221.