The revised ISO 17025:2017 Standard.
General requirements for the competence of testing and calibration laboratories.
The revised version of ISO 17025 has recently been published. There are new drivers in the standard for improved governance - requirements for confidentiality and impartiality; an enhanced sampling process, which addresses the uncertainty of sampling; business development, in the form of assessing 'opportunities' and managing risks, of all types.
The revised layout of the standard is similar to a ‘business model’; this is illustrated in Figure B1 in the standard using the sub-clauses in Clause 7, ‘Resources’. It is very important to address all the clauses involved, 4 to 8, so as to produce a sound (quality) management system.
As the standard is a world one, for all testing and calibration laboratories that wish to be accredited, that is, third party quality assured, it needs to meet the expectations of all its stakeholders – laboratories, customers, banks, insurers and the general public. It should not be too prescriptive, nor too vague. The debate on where the revised standard is positioned will probably go on until the next revision.
One unusual aspect of the standard is that it no longer specifies the requirement for a 'Quality Manager'. It does ask for, in Clause 5, that the laboratory shall "Identify management that has overall responsibility for the laboratory". This is similar to ISO 9001:2015, where specific titles are not sought, but roles and responsibilities need to be defined by the business.
When a testing or calibration laboratory operates to the standard, it needs to be at least compliant, with only non-critical nonconformances against the company management system. It could be said that this scenario just puts the laboratory in the 'average' category.
What customers want and need is a high-performing laboratory that 'ticks all the boxes' - Accuracy, defined turnaround-time, customer service and not forgetting, price.
What can be done to assist laboratories in this era of a new standard and raised customer expectations?
Is help on the way? See next time.