CASCO (Conformity Assessment Standards Committee) is the ISO committee that develops policy and publishes standards related to conformity assessment.
CASCO's standards development activities are carried out by working groups made up of experts put forward by the ISO member bodies. The experts are individuals who possess specific knowledge relating to the activities to be undertaken by the working group. In Australia, the ISO member body is Standards Australia.
Following a standard’s publication, it is reviewed once every five years by ISO to keep it current. An outcome of a review may be to not revise a standard and this is determined by ballot of ISO member bodies.
The last review of ISO/IEC 17025 was in 2010. At that time, the international community voted against revising the standard, however, since then opinion has changed and a push was made to have the standard updated.
Accordingly, a New Work Item Proposal (NWIP) was submitted to ISO and approved in October 2014. An ISO/CASCO working group has since been established (WG44) and tasked with the revision of the standard.
Some of the main justifications in support of the NWIP included:
- the standard and its terminology is outdated (8 years at the time the NWIP was submitted to ISO);
- the scope of the standard requires revision and updating e.g. “what is a laboratory and the activities undertaken?”;
- the current prescriptive approach is out of step with the modern standards approaches which are performance-based or process-based;
- impartiality needs to be addressed in a more informed way;
- subcontracting circumstances need to be clarified;
- traceability requirements should be expanded/clarified along more informed lines;
- sampling and sub-sampling needs to be considered with more recognition that reliable test results are directly related to sampling;
- separating the testing and calibration specific requirements in the standard needs to be reconsidered;
- there should be recognition of the use of computer systems, electronic records and report issues, as well as remote issuing of results/reports;
- software validation to allow for its relevance to testing and result generation, as well as records management requires addressing;
- there are too many notes included in the current version which make it difficult to use.
Standards Australia, being our nation’s ISO member body has appointed two members to participate in the activities of WG44. One of these members is NATA’s General Manager - Operations & Technical, Mr John Styzinski.
Since February 2015, WG44 has had three meetings.
Key points to note from the activities of WG44 include:
- agreement that the current standard is not fundamentally “broken”, accordingly the requirements will not be significantly changed other than “tidied-up”;
- the revised standard will look significantly different due to the adoption of the mandatory requirements specified by ISO/CASCO in QS-CAS-PROC/33 and the structure is to be consistent with CASCO Resolution 12/2002 (covered in QS-CAS-PROC/01):
- PROC/33: covers requirements concerning impartiality, confidentiality, complaints / appeals and management systems.
- Resolution 12/2002: covers the layout of CASCO standards in a set order
- Terms and definitions
- Structural requirements
- Resource requirements (including human resources)
- Process requirements (including operational functions)
- Management system requirements
- Normative annexes
(The 2012 version of ISO/IEC 17020 has adopted the above two points).
The development process for ISO standards is divided into separate stages including:
This stage covers the preparation of a working draft (WD) by the WG conforming to the ISO/IEC directives. The preparatory stage ends when a working draft is available as a first committee draft (CD).
The revision of ISO/IEC 17025 is now approaching this stage.
This stage is when comments on the draft from national member bodies are taken into consideration, with a view of reaching consensus. The committee stage ends when all issues have been resolved and a CD is accepted for circulation as an enquiry draft i.e. a Draft International Standard (DIS). Further CDs may be necessary where consensus is not reached prior to a DIS being available.
At the enquiry phase, the Draft International Standard (DIS) is circulated to all national member bodies for comment and vote.
Typically, the national bodies’ mirror committees are responsible for monitoring and participating in the work of the relevant ISO committee.
In Australia’s case, Standards Australia’s QR-010 is the mirror committee of ISO/CASCO. Members of the mirror committee are responsible for consulting with their nominating organisation for their position on the standard to be considered by the rest of QR-10 when coordinating Australia’s position.
By virtue of NATA’s representation on QR-010, NATA will request feedback from its members on the DIS in order to coordinate an appropriate response to bring back to the mirror committee for its consideration.
It is to be noted that it is Standards Australia and not NATA who will vote and provide its feedback to ISO on the revised standard.
At this stage it is anticipated that the DIS will be released in the first half of 2016 if the CD is passed.
The mechanism on how NATA will seek and provide feedback is yet to be determined. However, NATA members will be informed of this process in in due course.
The DIS is approved if two-thirds of national member bodies are in favour and not more than one-quarter of the total number of votes cast are negative.
If the DIS is approved the project will go straight to publication. However, should the draft be significantly revised following comments at the DIS stage (even if the DIS has been approved) a decision may be made to prepare a Final Draft International Standard (FDIS) and circulate it to national member bodies for a further vote.
At this stage the final draft is submitted for publication and only editorial corrections are made to the text.
According to the WG44 work plan, it is expected that the revised version of the standard will be published in mid 2017.
Further information on the development of standards can be obtained from the Standards Australia’s website.