The Changing Assessment
Process
Graham Fews
West midlands Regional Genetics
Laboratory
UKAS Technical Assessor
Disclaimer
• UKAS Technical Assessors do not offer
consultancy.
• The views presented are my own and do not
necessarily portray those of UKAS.
Bermuda triangle?
• Is the ISO 15189 process full of myth, mystery
and misunderstanding?
• Assessors have ‘split roles’ – WMRGL, UKAS,
NSHCS.
• If you go home with a more clear
understanding of ISO 15189 the day will have
been worthwhile.
Myth
• We are moving from CPA standards to
ISO 15189.
• Not strictly true – CPA standards always
referenced relevant clauses within ISO 15189
and other relevant Standards.
• The first assessment is a gap analysis.
• Not true - It is the laboratory’s responsibility
to undertake the gap analysis.
Technical Assessors
• Peer Assessors have become Technical
Assessors.
• Technical assessors are still critical to the
success of the assessment process.
• Our role is to assess Technical Requirements
and the clauses within.
• This does not mean we will not identify nonconformity within our clauses during our
investigations.
• All assessors undergo training in ISO 15189.
• All assessors are assessed for their
competence in ISO 15189 assessment.
• UKAS themselves are also assessed.
• Quality is at the heart of the whole process.
Previously…
• CPA assessment utilised:
– Vertical Audits
– Horizontal Audits
– Examination Audits
– User Meeting / Questionnaire.
Now…
• UKAS assessment under ISO 15189 uses
assessment by ‘any means’ to get to the
required end point.
• However; the process is considered more
holistic.
• The majority of technical assessment is
provided by witness audit.
• The initial assessments are generally long.
AC4 form
• Labs have to complete AC4 form.
• This provides the scope of testing that the
laboratory is asking to be assessed against.
• Requires details of tests, sample types, key
equipment and SOPs.
• Think about how you fill it in.
• If you are too specific any new testing may
require an extension to scope.
• This form is given to the Assessment Manager
who will organise the assessment.
• The Assessment Manager contacts Technical
Assessors to check availability.
• Technical Assessors do not know who the lab
is until the visit has been confirmed.
Before the visit
• Labs will be asked to provide relevant
information including key SOPs for assessors
to review.
• Assessors read and prepare for the visit.
• UKAS include this assessor preparation time in
the calculation of visits.
During the visit
• The assessor team will arrive and have a
welcome meeting with key staff.
• There is no requirement for a closing meeting
each day.
• Assessors will assess each area within the
scope of assessment.
• Findings will be fed back as soon as possible to
enable labs to decide what action will be
taken.
Non-conformities
• Previously non-conformities were given for
each part of an examination where
appropriate.
• Under ISO 15189 the aim is to identify the
specific cause that has occurred.
• Assessors use more of a route cause model in
the assessment process.
Be prepared!
• In general the holistic nature leads to a
friendly, open assessment.
• Think ahead – prepare a list of what assessors
can see when.
• If they won’t be able to see something let
them know asap so alternative means of
assessment can be performed.
• Have relevant paperwork to hand – EQA
reports etc.
• Assessors will wish to see training,
competence and CPD records.
At the end of the Assessment
• At the end of the assessment the assessor
team will meet with key staff and go through
the list of non-conformities.
• Labs are required to provide information as to
how they will clear the non-conformity.
• These agreed actions will be documented on
the Improvement Action Report and a copy
left with the lab and sent to UKAS.
• At this stage the Assessment Manager will
recommend whether department has attained
the required level to a) maintain CPA
accreditation b) be recommended for
ISO 15189 accreditation.
• Accreditation is only given once nonconformities are cleared.
• CPA non-conformities are to be cleared in 8
weeks.
• UKAS non-conformities are to be cleared in 12
weeks.
Post assessment
• Assessors write up a report on the visit.
• This report is provided to both the
department and UKAS.
• Labs must provide evidence for clearing nonconformities within the relevant timeframe.
• UKAS ISO 15189 accreditation is currently only
ratified approx twice a year until fully
embedded.
Schedule of Accreditation
• The Assessment Manager and Lab will work
together to develop a Schedule of
Accreditation.
• This is what you are accredited to provide.
• IMPORTANT – it is the assessed tests that are
accredited and NOT the laboratory.
• Any new tests or changes to accredited
equipment requires consideration of an
extension to scope.
Caution…
• ISO 15189 is subject to copyright.
• If a provider of a service is UKAS accredited for
that service they will provide a certificate that
shows the UKAS logo.
• If a provider of a service says they are
traceable to UKAS/ISO standards ask how.
And Finally…
• Technical Assessors are not paid.
• It is hard work, but rewarding.
• Assessment process relies on availability of
assessors.
• It is your profession - be involved.