Three ISO 17025 Questions

[Hershal]

Isolisa, some hopefully simple answers.

First things first. Get to a training session on ISO/IEC 17025, so that you have a good grasp on the application of the Standard. Also, make sure you have and read the Standard.

Also, get training on measurement uncertainty. It is a requirement for accreditation for calibration.

You almost certainly will need a manual for the lab itself. Where the ISO 9001 manual ADEQUATELY addresses the topics in ANS/ISO/IEC 17025:2005, then piggy-back on that. However, you will find that much of the time, that will not be the case, as 17025 has specificity in requirements that 9K does not. Address those differences in the lab manual.

You will need an internal audit and Management Review prior to any accreditation assessment, and should do them anyway to make sure everything is implemented. Now having stated that, both can dovetail onto the parent audit and review; however note that there are requirements for the lab. The audit must include not just the QMS, but also the technical component of the lab. The Management Review can be included in the parent's review, but note that 17025 has a prescriptive agenda in Clause 4.15.1, and the topics must be easily identifiable within the review if combined with the parent.

Lower level procedures can be modified, and should make it a bit easier for you. Remember, 17025 may well have additional specific requirements that must be taken into account.

One last point. Regarding accreditation, there are six internationally recognized accreditation bodies (ABs) based in the US. Do NOT sign with ANY of them until you have had some in depth discussion with ALL of them. And make sure that you are talking with technical folks, not just sales people. Remember, the assessment requirements include technical review so you should have confidence and comfort that the AB understands your needs.

Hope this helps.