Is there a change to auditing in the revision to the ISO/IEC 17025:2017 standard?
Posted by Cathy Wylie on
The short answer to the question of whether there are changes how an auditor conducts the internal audit is, it depends. Certainly the focus of the revised standard has changed to performance-based requirements, and that may affect how auditors approach their audits. If you are already looking beyond just whether the laboratory is meeting the requirements of a particular clause and are looking for how well the lab has implemented the requirement, and whether it is effective, you may be well on your way to conducting an effective audit of the 2017 standard.
The introduction of risk-based thinking in the standard impacts the auditing process. Not only do you need to apply risk-based thinking to your audit plan, each auditor needs to apply risk-based thinking as they do they audit and they need to be looking for evidence that risk-based thinking is being applied throughout the laboratory.
The less prescriptive clauses in the revised standard drive a change in the approach to an audit. Under the 2005 version of the standard, the requirements were more specific. Auditors could look at the requirement and look at whether the lab was meeting that requirement. Now there is terminology such as "sufficient," "ensure," and "suitable" that may require auditors to look closer to assess whether what the lab is doing meets the requirement in addition to considering whether risk has been addressed.
Auditors need to be competent. Auditors who were trained to audit against ISO/IEC 17025:2005 need to learn the requirement of the 2017 standard. CALA has several courses to assist with this. The new Auditing Against ISO/IEC 17025:2017 course provides experienced auditors with the skills they need to conduct an audit against the new standard. It covers the changes to the standard that all auditors need to be aware of, including how to audit for risk-based thinking. This is a highly interactive course where the learning is done primarily through discussions with fellow auditors, and case studies based on the revised requirements in the standard. Click here for upcoming dates and for more information.