It is up to the laboratory to include an assessment of these three criteria when planning an audit and to decide what should be included on their audit. What findings or areas of concern were included on the audit or assessment report? Results from the previous audit is also included as a consideration.
This could be changes to the standard method, test method, equipment, staff, supplier, etc. Which procedures, both technical or part of the management system, are critical to the work your laboratory does? This may mean tests that are the main source of your income, or that are conducted for critical clients.Ĭhanges affecting the laboratory also need to be considered. So, what do you need to consider? First of all, the importance of the laboratory activities concerned. When planning your audits under the 2017 version of the standard, you need to apply risk-based thinking and decide what areas of the laboratories and specific procedures need to be included in the audit. The biggest change in the requirements for internal audits comes in clause 8.8.2 (a) which states that laboratories “…shall take into consideration the importance of the laboratory activities concerned, changes affecting the laboratory, and the results of previous audits.” This clause is about risk-based thinking.
Planning for internal audits under the ISO/IEC 17025:2017 standard may be different for your laboratory.