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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...

Many laboratories are introducing risk registers as one way of showing that risk-based thinking is being used in the laboratory. However, once the risk register is set up, some laboratories are struggling with what to with the register. First of all, remember that a risk register is a tool that should provide your laboratory with benefits such as improved, proactive management of risks. If the risk register is a 'make-work' tool that is not providing benefits it may be time to reassess your approach. You do not need to track every possible risk throughout your management system on the risk register....

Things your laboratory manager expects from you, but may not tell you Successful people know that not everything required in their job is covered in their job description, or is clearly communicated by your supervisor or manager. Here are are some of them.... Write clear emails Find problems before they occur Report the recurring issues – even if they are small Expand your skill set over time (take training, read, ask questions) Don’t hold information that can help others thrive Keep the lab clean Encourage feedback from others Provide feedback to others Leverage the strengths of others around you Learn...

The turning of the calendar to a New Year is traditionally the time when we stop and reflect on the coming year and changes that we may want to make. This is always a good time to take a look at your laboratory's management system and to assess whether improvements are in order.  Laboratories making the change to ISO/IEC 17025:2017 For laboratories that have not yet made the change to the 2017 version of ISO/IEC 17025:2017, now is the time to start planning for the changes. Don't wait until your assessment is looming and then rush to make the required...

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...