The Changing Assessment Process

Graham FewsWest 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 non-conformity 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 non-conformities 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 non-

conformities 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.