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In late September a series of tornadoes hit the Ottawa area. In addition to the destruction caused by the storms, there were power outages and communication issues. If your laboratory was in an affected area, would your Business Continuity Plan  (BCP) have stood up?  A Business Continuity Plan (BCP) or Disaster Recovery Plan is a document that is used when there is a disruption to the normal functioning of your laboratory. The plan gets implemented if there is an extended power outage, weather incident, flu epidemic or other event that closes your laboratory unexpectedly. Based on the events in Ottawa,...

There are new requirements in ISO/IEC 17025:2017 related to impartiality. Section 4.1 covers impartiality, including the requirements for laboratory activities to be undertaken impartially;  structured and managed to safeguard impartiality, as well as the requirement to identify risks to impartiality. But what does being impartial mean? The definition in ISO/IEC 17025:2017 is "presence of objectivity" and is further clarified in a note saying, "Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory." In the context of laboratory testing, being impartial includes conducting laboratory activities without bias. Lab...

Planning for internal audits under the ISO/IEC 17025:2017 standard may be different for your laboratory. 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. 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. So, what do you need to...