The current version of the competence and governance Standard was a significant change from the previous version – in a nutshell 2017 brought the following changes:
- Scope revised to cover testing, calibration and sampling associated with subsequent calibration and testing.
- Risk-based thinking covered for the first time
- The process approach matches ISO 9001 (QMS), ISO 15189 (medical testing) and ISO/IEC 17021-1 (management systems certification).
- Stronger focus on information technologies and incorporates the use of computer systems, electronic records and the production of electronic results and reports.
So, how has the 2017 edition been accepted and, does anything need changing? ALAB’s view is that the Standard continues to be fit for purpose. It addresses key areas of the laboratory’s operations and includes provisions that are internationally accepted as criteria of best practice.
The committee responsible for the Standard (ISO CASCO – ISO Conformity Assessment Standards Committee) provides useful explainers (external content – opens in a new page).
However, an area of significant interest to laboratories is the role of digitalization and AI in laboratory operations.
Technology moves rapidly and when the current version was being drafted, there was considerably less knowledge and awareness of what was to come in this space.
There are potentially many laboratory processes that may benefit from digitalization and AI. One which is often mentioned is the maintenance of equipment lists but there are many other use cases.
We believe that any future revision of the Standard will need to incorporate appropriate governance provisions so that efficiencies gained through the use of digitalization and AI do not negatively affect the ability of the accreditation process to objectively evaluate competence and reliability.
This is clearly a challenge for the accreditation community and one that ALAB will pursue through its membership of laboratory accreditation cooperations such as APAC.
