Are you ready for your ISO/IEC 17025:2017 assessment?
Posted by Cathy Wylie on
While researching the content for the upcoming webinar, Assessments under ISO/IEC 17025:2017 - The results so far, several labs provided their lessons learned about their first assessment to the revised standard.
Risk-based thinking tops the list of items that labs grappled with while updating their management systems. Under the 2005 version of the standard, risk was managed. Now laboratories need to understand where there are risks and opportunities and proactively assess risks throughout the management system. Most laboratories reported that they had trouble understanding what needed to be done on risk. The laboratories that reported they were comfortable with risk-based thinking had invested in training their staff on risk.
The next concern was the new wording in the standard. Due to the prescriptive nature of the 2005 standard, laboratories were accustomed to requirements that were relatively straightforward and had little latitude for interpretation. The revised standard's use of 'shall ensure' instead of 'shall have a policy and procedure' in many clauses caused some concern. However, since the majority of technical requirements in the 2017 standard are not substantially changed, many laboratories reported that they soon realized that a good portion of their quality documentation meets the revised requirements.
The gap analysis that needs to be submitted ahead of the first assessment to the 2017 standard has proven to be a useful for most laboratories. It forced them to look at what changes they needed to do. The people who indicated that they attended the ISO/IEC 17025:2017 - What's New or Different course and did their gap analysis reported that they were highly confident when completing their gap analysis and updating their management systems.
For more details on the experiences of the laboratories that have completed their 2017 assessments, the findings that have been coming from the 2017 assessments and the observations of the assessors, plan to attend the Assessments under ISO/IEC 17025:2017 - The results so far webinar on November 21.