Quality Management and ISO 17025

A nice and well-equipped laboratory building, state-of-the-art equipment, well trained and motivated staff and all that under good and efficient management – at first glance this seems to be all that is required to produce good laboratory output and analytical results.

We know of course that this is not the case. You need to show that your measurements are accurate and reproducible, that your lab is impartial towards the customer, follows science based analytical procedures, that you have a system in place to deal with errors and deviations from your documented procedures. In short you require Quality Control (QC), Quality Assurance (QA) and a Quality Management System (QMS). You also need an external body to certify you against an internationally accepted standard. In case of chemical analytical work related to CBRN materials this standard is the norm ISO 17025 and the certifying body is normally your national accreditation body.

  • We are offering our clients advice and guidance on the way to ISO17025 accreditation. From the first steps of planning, via the definition of the scope of accreditation, the creation of required documents (quality manual, standard operating procedure and work instructions), the creation of an effective management system, the implementation of internal audits and working with your external accreditation agency towards the first external audit.
  • We offer our services also after your laboratory received accrediation by helping you to implement revision cycles for quality documents, plan for and conduct your internal and external audits and re-accreditation while working towards improvements in the system and the quality of analysis results.
  • ISO17025 accreditation is a mandatory requirement for being an OPCW designated laboratory (together with successful participation in Proficiency Tests).

Quality Management Systems do not need to be a bureaucratic nightmare

For many people working in an accredited area the idea of QM is related to overburdening bureaucracy, paperwork and an overhead of additional work that impedes the main analytical tasks in the lab. We believe that QM systems can have a tendency to develop in such a direction but that that a properly implemented system can achieve the goals of quality management (delivery of results following standardized practices, maintaining and gradually improving the quality of procedures and results) without turning into an administrative nightmare.

Specific challenges of ISO17025 accreditation for chemical defence labs – Flexible scopes

While accredited methods for the determination of specific pathogens or types of radiation and radioactive materials can be created in a rather straight forward manner, doing the same in the field of chemical defence is quite more challenging as the number of target analytes is practically unlimited (e.g. there is an unlimited number of chemicals in Annex on Chemicals of the Chemical Weapons Convention – so called “scheduled chemicals”). This requires an accreditation with a flexible scope and for qualitative (and not quantitative) analysis. This is rare combination for accreditation bodies and requires a careful and thoughtful approach when working with them on the way to accreditation.