The new version of the ISO/IEC 17025 standard is expected out by the end of 2017. Once the final version is published there is a three year phase in period. That does not necessarily mean that your laboratory can wait until the end of the three years to move to the new standard. Your accreditation body needs to have all laboratories assessed to the new standard by the end of that three year period.
What is the current status of the standard?
The new version of the ISO/IEC 17025 standard is going to Final Draft International Standard (FDIS). The FDIS will be released soon (forecast for August) for a short voting period. If that vote passes, the revised version of the standard will move into the publication phase, with an expected release in late 2017.
When does my laboratory need to conform to the new standard?
Accredited laboratories in Canada are typically assessed every two years. For the first year after the new standard is published, laboratories can choose to be assessed to either the 2005 version of the standard, or the new version.
One year after the standard is published, assessments will be done against the new version of the standard. The reason for this is the two year cycle. The last assessment visit you have prior to the three year deadline is when you need to conform to the new standard. The graphic below shows how the assessments are expected to be conducted.
Let’s look at an example. The new standard gets published in November 2017. Accreditation bodies will need to have all laboratories assessed to the new standard by November 2020. Your next assessment visit is January 2019. Based on your assessment cycle your January 2019 assessment needs to be against the new standard. Otherwise your laboratory will not meet the requirement to be accredited by November 2020.
Getting ready for the transition
You can start planning your laboratory’s transition using the FDIS of the new standard. However, you will need to purchase a copy of the new standard after it is available.
The main steps to make the transition are:
- Conduct a gap analysis between your current quality system and the requirements in the revised standard.
- Decide on your timeline. Make sure the timeline fits with your reassessment schedule.
- Update your documentation. This includes updates to existing policies and procedures as required, plus the addition of any new policies and procedures.
- Create a training plan and a communication plan
- Implement the new and revised policies and procedures.
Some things to keep in mind. Your laboratory needs to continue to conform to the current standard up until your assessment against the new standard.
CALA has training available on the revised ISO/IEC 17025 standard. Click here for details on these courses.