Pilot Modules and ISO/IEC 17043:2010 Accreditation

Pilot Modules and ISO/IEC 17043:2010 Accreditation

This guidance applies to non-accredited UK NEQAS programmes only.

Accreditation to ISO/IEC 17043:2010 is specific for individual EQA Schemes and the analytes within. It will, by necessity, take a period of time for an individual EQA Scheme to obtain full ISO/IEC 17043:2010 accreditation as there is an ‘extension to scope’ process that the UK NEQAS centre will need to follow.

Whilst using fully ISO/IEC 17043:2010 accredited Schemes is the ideal, this is not always possible as new programmes are implemented and developed on a continual basis and will not be ‘instantly’ accredited. So, it should be noted that it is not mandatory for laboratories to use an ISO/IEC 17043:2010 accredited EQA Scheme, although this may be what is recorded within local Quality Management Systems.

The ISO 15189:2012 standard says: NOTE The laboratory should participate in interlaboratory comparison programmes that substantially fulfil the relevant requirements of ISO/IEC 17043.

In terms of UK NEQAS EQA schemes, all UK NEQAS members are accredited to ISO/IEC 17043:2010, with the majority of Schemes within the scope of accreditation. However, all Schemes are treated the same whether they are within the scope of ISO/IEC 17043:2010 accreditation or not. This means that they are managed within the same Quality Management System as accredited Schemes and are operated by the same highly qualified staff, using established working practices in the same way as accredited Schemes.

As with all suppliers, there is a requirement to risk assess the service that they provide. When risk assessing your EQA supplier you should be looking for more than whether the Scheme is accredited to ISO/IEC 17043:2010 [This is the ISO standard for Conformity assessment — General requirements for proficiency testing and all UK NEQAS members are accredited to this standard]. Additional considerations when assessing an EQA service would include:

  1. Does the service provide you with sufficient information for you to be assured of the quality of the service that you are providing to your users?
  2. Are the specimens that the EQA programme issues of a suitable matrix, frequency and concentration range
  3. Are the reports easy to interpret and do they contain the information that you require?

The EQA programmes operated by UK NEQAS are designed to meet all these requirements and more. This harmonised approach ensures the provision of high-quality EQA Schemes across the range of clinical laboratory testing.

This is because UK NEQAS takes the view that EQA is very much more than just a tick box exercise for laboratories to use in achieving accreditation, and the EQA Schemes we provide reflect this belief.

As always if you have any questions regarding any aspect of UK NEQAS, be it accreditation, Scheme design or any other topic please discuss it with the relevant UK NEQAS Centre in the first instance if you have any concerns.