As we stand today, all the labs have either migrated or are looking forward to their next audit to showcase their changed operations conforming to ISO/IEC17025:2017 guidelines published by ISO/IEC in November 2017, and many are still attending training and conducting gap analysis wrt earlier operating procedures that was compliant to . By now, as most of the pundits and experts on updated standard have indicated that the new version has given larger emphasis on Information Management system and wherever required removed the requirement of maintaining hard-copy or paper records.
In this blog, my focus is on understanding and informing what is different and how it would impact to Lab operations, one running on paper based process vs those using SCC Lab information management systems (LIMS) software.
At SCC, We recognize that it is our responsibility to keep our customers ahead of their competitors. SCC has finished changes to its LIMS solution to help our customers remain compliant to new Standard ISO/IEC 17025:2017. These upgrade are free of cost and we will release the upgrade to all willing customers as and when they are ready with the process documentation changes.
Clause 7.4. When the laboratory is testing or calibrating item in different environment conditions then standard test procedure, if asked by the customer or when it is out of the permanent lab facility. The laboratory is expected to include a include a disclaimer in the report indicating which results may be affected by the deviation (7.4.3) caused due to different conditions that has been prescribed by the customer (its implementation is in 7.8 Report section as well).
It is possible to include two disclaimers in the report, one relating to the sample and other relating to the sampling condition and method.
Clause 7.5. Earlier standard requirement of crossing out and initialing of mistakes has been removed instead now it requires whole of previous version to be retained and new form to be used for any correction. All the older version should be retained along with the details such as person responsible for the change (7.5.2).
SCC LIMS keeps a record of original result recorded on database along with who had entered the result with timestamp.
Clause 7.6. There is requirement for testing laboratories to consider uncertainty in reporting final result calculation if the test conditions are not in controlled environment.
In case of testing LIMS, calculation if are beyond uncertainty, user may put this remarks in their inference. In Calibration LIMS, automatic calculations if are done would have taken care of environment conditions and inference remarks could be entered by the user in accordance to claim.
Clause 7.8. Report layout,
- The date of issue of report has been made essential in the test/calibration report.
Our customers are already using it, In addition we have option that report number could be different from sample number and could be a series that would be dependent on date of issue of report. For indian laboratories, an additional requirement known as Unique Lab Report (To know more about ULR, read this Impact of NABL ULR on laboratories)has been introduced by the NABL (the national accreditation board of laboratories of India) and hence distinct report number is already supported in the system.
- Instead of signature, name of authorising authority has been included. Digital signature from LIMS are welcomed now to make labs paperless
SCC LIMS have feature to include signatures of Engineer/Test analyst and Approving authority on generated PDF report
- Disclaimers: Two sets are recommended, one on part relates to the information provided by the customer while other is related to the sampling when the laboratory has not done it by themselves.
Same as response to 7,4 in addition, SCC already have the option that approver can add remarks that will be printed as inference, or note that could be printed as footnote of result table.
- Statement of conformity when made in the report must specify the specific test parameter(s) where non-conformance is observed and decision rule applied.
Non conformity test results are printed in different color or style in the test result table to highlight the non-conformance.
In Smartcalibration LIMS also, user can specify acceptance range of result thus allowing points not conforming to be printed in Bold
- Opinion or interpretation of results must be communicated by authorized personal
A email indicating non-conformance could be sent through the LIMS application to the lab approver to seek their advise and act accordingly. Non-Conformity is reflected in the test report as Line in Bold Color to differentiate it from others.
- When revision of report is required, the reason and details of changes must be specified in the test report.
SCC LIMS already taking reason seeking revision from Approving authority, that could be printed as well in the test report. In addition, SCC LIMS is also keeping log of all the revisions done with their remarks and person who has authorized rework on the report.
Clause 7.11 Control of data and information system, clearly indicates now that Commercial off-the-shelf software can be considered to be sufficiently validated.
Validation of information system is still essential to include checks such as in-appropriate accesses, calculation of results, protection against tampering and backups.
In case, you wish to know more or have doubt on other clauses of ISO-17025, or would like to take a demo of the SCC LIMS product. feel free to contact us with a brief of your requirement.
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