Accreditation Corner

Can academic establishments comply with ISO 17025 or be accredited?

In this issue Trevor considers the potential issues encountered when applying management system standards such as ISO 17025:2017 to testing and calibration work in universities and technical colleges.

University measurement facilities are often very advanced, often at the frontiers of the science, often very expensive and sometimes complex.  These are the very reasons why making use of these facilities to provide a testing or calibration service to industry may appeal.  This clearly benefits the university itself by providing financial income with a raised industrial profile, and the industry by providing often unique and special measurement services.

It should be possible for such facilities to comply with ISO 17025 and even to obtain accreditation, indeed many do, but several rather daunting issues tend to become apparent and need to be overcome.

Of course all compliant laboratories need to abide by all the clauses in the Standard but it is certain topics that tend to trouble academic establishments:

Care and Control of Equipment is an important point.  There is an expectation that equipment be maintained in a known and good condition with use being limited to authorised staff who are trained in its proper use, often within stated limits.  This applies not only to measuring equipment that is calibrated but also to any other kit such as jigs, that could affect the validity of results.  Using that equipment as part of teaching students is problematic.  Ideally one duplicates the kit and reserves one set for controlled use, letting students use only the other one, unless that student has been individually trained, competency tested and authorised.  Sometimes that is not feasible so alternatives might include  ensuring 100% supervision by an authorised person and limiting the use to the same limited parameters as those for calibration or testing service.   That person would spot and alert situations of abuse or overload so the equipment may be immediately taken out of service pending rectification.  Other possible options include routine re-verification or re-calibration of the equipment prior to 17025 use.  Difficulties such as the lack of drift history may preclude some possibilities in particular cases but this very much depends on the nature of the work and the uncertainty budget.  A blend of some equipment being accessible to students, such as big, rugged rigs, but the more delicate measuring devices being duplicated is often a viable solution[PL1] [TJT2] .

Authorised Staff – 17025 requires all staff involved in the testing or calibration being known, competent and authorised.  This is relatively easy [PL3] [TJT4] in that one may identify staff and long-term students such as resident PhDs who undertake the 17025 compliant work and document the competence criteria but if anyone else is to touch the equipment it is essential that one knows this and that it cannot affect performance or that the equipment is revalidated or recalibrated after such exposure as discussed under Care and Control of Equipment above.   All staff undertaking the other functions such as contract review, recording and reporting also, of course, are required to be trained and authorised but this does not usually need to involve any transient students.

Legal Entities, Ownership and Impartiality are other requirements sometimes exercising academic establishments. Compliance, whether accredited or not does require a single legal entity to be identified as responsible and that normally undertakes the work itself.   This means that the entity shall employ the staff although that may be by contracting the people from another entity. That is not the same as subcontracting the activity.  Those staff may be bought usually by the day or hour to follow the laboratory’s management system and will have records within that system.

 This may be an issue for universities that set up a spin-out [TJT5] associated limited company for tax or other reasons.    If it is the ltd bolt-on that seeks to comply then it would need to show that it had the care and control of the equipment and of the staff.  However, the ownership of the equipment and of the staff is not the issue.  It is a matter of care and control.  It is essential that staff used understand the management system requirements, the impartiality and confidentiality issues such that in a university environment one might expect a greater than average attention to doing this demonstrably well and documenting it.

Students are sometimes considered the main problem.  This may not be the case.  In any laboratory there are new staff undertaking training who are closely monitored because they pose a risk.  In a university the students clearly pose a risk that should be studied under the risk and opportunity regime in order to identify where, what and who are involved and how high the risk is.  This will mean some processes and some equipment being identified as potentially at risk.  It would be that area where one would consider duplicating the kit, or 100% supervision by authorised staff and all use well controlled and documented.

Is all this economically viable?  That is very hard to answer!  At one extreme, situations have been seen where the service offered is very competitive with the private sector because only marginal additional cost recovery is sought, the fixed main costs continuing as before financed within the education spend.

At the other extreme, the service offered under a “full economic cost” type regime may appear excessively expensive and non-appealing to industry.  However, if the offering is unique, some customers may want it.

Those of us scientists and engineers that also dabble in business and economics will know that there is no such thing as “true cost” and the split between different cost or recovery centres is a matter of policy.  In any case university laboratory measurement work that is 17025 compliant or accredited may have [PL6] [TJT7] [TJT8] greater credibility when publishing research work containing such results.  That alone inspires some applicants.

 

Trevor Thompson was for many years an assessor, assessment manager and senior manager at The United Kingdom Accreditation Service.  He represented the UK in the writing of the latest version of ISO 17025 and has now retired.

He presently offers Accreditation and Metrology Consultancy for the UK, Europe and Beyond – bestmeasurement.com