Following the success of our recent ISO 17025:2017 workshop, we received a number of questions which we put to the panel of experts. The questions and answers are given below:
Director of Laboratories,
Director of Quality,
Head of Operations Support,
Q1. What is the difference between inter laboratory comparison and proficiency testing?
Proficiency Testing (PT) is one form of interlaboratory comparison (ILC).
Benefits of PT include the fact that it may be operated in accordance with an international Standard ISO/IEC 17043 and may be accredited. In any case it is external to the laboratory and offers the advantage therefore of capturing some at least systematic components of uncertainty. Other forms of ILC include small informal arrangements between labs, use of an accreditation body’s Measurement Audit Service, internal comparisons within a laboratory. The new Standard is very clear that external as well as internal exercises are required. Internal comparisons are unlikely to capture systematic components of uncertainty like “bias”.
Q2. What criteria should I be using for choosing between Internal, External, Intra and Inter laboratory?
I would give priority to accredited PT where available, but also include internal and less formal external comparisons to augment this for parameters or tests where external is not available or is not comprehensive. See Q1. The criteria would be to get the best coverage of the scope, using whatever is available, given that external is usually better than internal but not always available.
Q3. What is the difference between "Reference Standards" and "Reference Materials"?
Not a lot! This depends on what you are doing; a reference standard is a device or artefact that provides your metrological traceability. In some cases a reference material (if it is a certified reference material (CRM)) may do this, but in most cases a reference material is just a stable reference used in setting up or confirming tests.
Q4. Where in 17025:2017 does it cover client feedback? (I.e 17025: 2005: clause 4.7.2) I know 17025: 2005: clause 4.7.1 is covered in clause 7.1.7 in 2017 standard but can't see where clause 4.7.2 of 2005 standard is covered in 2017 standard? And how do our obligations on feedback change, if at all?
I don’t see any change in practice. 8.6.2 The laboratory shall seek feedback, both positive and negative, from its customers. The feedback shall be analysed and used to improve the management system, laboratory activities and customer service.
Q5. How do you evaluate the effectiveness of the management system and its processes in ISO17025:2017
No change from earlier versions and as in 9001 etc. Suggest reduction in complaints, enhanced customer satisfaction, staff wellbeing, profit etc. It is for you to determine how best to collect and collate this.
Q6. Verification of test methods - ISO/IEC - 17025:2017 clause 126.96.36.199 "The laboratory shall verify that it can properly perform methods before introducing them by ensuring that it can achieve the required performance. Records of the verification shall be retained. If the method is revised by the issuing body, verification shall be repeated to the extent necessary." Is it accepted to use IQC and/or PTs as verification tools without doing the repeatability and accuracy calculations?
This would be a technical judgement call depending on the nature of the changes made. One external PT would not capture the random component from staff variations for example so if the change involved a higher skill level than some internal exercises would also be indicated. If different measuring equipment was used or different form of traceability then external would usually be best. You must decide this yourselves.
Q7. Impartiality Indicator - To address item 8.2.2: "Policies and objectives should address competence, impartiality and consistent operation of the laboratory," stating that the laboratory should have an objective aimed at impartiality. What are the possible monitoring tools for an indicator of impartiality?
See Q5. Reduction in complaints about impartiality would be one indicator. Reports from staff about related pressure would be another. Internal and external auditor reports.
Q8. What is the difference between (Metrological Traceability) which is mentioned in ISO 17025:2017 and (traceability ) mentioned in ISO 17025:2005 regarding the definition and way to comply?
None, except that in the Annexe (non-mandatory text) there is now an acknowledgement that sometimes Certificates of Conformity may be acceptable.
Q9. Does it really make a difference if I adopt 17025:2017 rather than sticking with 9001 as my management system standard?
There is little difference in practice for most labs. Either way you will need to ensure that all the requirements of ISO/IEC 17025:2017 are met. It is best to have only one and coherent management system, so if you do other things as well as testing/calibration you may wish to take the 9001 route, providing a chapter on the lab and 17025 additional requirements.