1. CPA is a UKAS company The Assessment Process 2014 Seminars

2. CPA is a UKAS company The Assessment Process Application information Resource requirements Preparation for the assessment The assessment - on the day Reporting and improvement actions

3. CPA is a UKAS company Accreditation ISO/IEC 17000: 2004 Third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks

4. CPA is a UKAS company In simple terms….. Providing confidence that a body can provide reliable, reproducible outcomes that are fit for purpose Expectation that one will get the ‘right’ result and a reliable outcome

5. CPA is a UKAS company Purpose of Assessment Can you demonstrate your competence? Has competence been maintained since the last assessment –Records, minutes, feedback, complaints Are you still competent now? –Witnessing, interviewing, questioning How will you maintain competence in the future? –Effective & compliant Quality Management System

6. CPA is a UKAS company Application Information UKAS Application Form AC4 Form UKAS Agreement and supplement

7. CPA is a UKAS company AC 4 Form Scope of activity – repertoire, equipment and location

8. CPA is a UKAS company AC 4 Form Identification of other activities that support the functioning of the laboratory and where these activities are conducted e.g. facilities management, HR, Procurement etc Identification of activities outside of the scope of ISO 15189 Details of in-house calibration activities Details of locations

9. CPA is a UKAS company Schedule of Accreditation Blood – Ammonia -SOP xxx using Ammonia Checker II/A-4120

10. CPA is a UKAS company Application Review Application information will be reviewed Additional information may be requested Decision will be made on the expertise and time required for the assessment taking into account: –Repertoire- CPA history –Locations- Size of operation –Other activities

11. CPA is a UKAS company Assessment Team Application review will determine team and duration Assessment Manager plus Technical Expert – some could be involved remotely, before or after on-site assessment – all trained in ISO 15189 UKAS Observer – to monitor and review

12. CPA is a UKAS company Assessment Preparation Provision of additional information from the lab is likely –Gap analysis – specific issues –System documentation and procedures UKAS will provide a visit plan –Timetable for the assessment –Indicate what activities will be assessed and ‘witnessed’

13. CPA is a UKAS company The Assessment (1) Planned in advance to cover ISO 15189 (and CPA) requirements Assessment team will be prepared There will be a consistent approach but it will not be uniform Tasks will be allocated to Assessment Team members as per plan May need to deviate from the plan

14. CPA is a UKAS company The Assessment (2) Opening Meeting Assessment Manager will act as the Lead Assessor Lead Assessor will focus on: –Gap analysis outcomes –Management System incl. supporting activities –Coordinate technical experts

15. CPA is a UKAS company The Assessment (3) Technical Experts: –Allocated tasks covering the process from sample receipt to ‘reporting’/post examination –May use reporting forms but not checklists –Will assess aspects using horizontal and vertical techniques –Evidence based assessment – ‘show me’

16. CPA is a UKAS company The Assessment (4) Objective statements will be used to record any potential nonconformities or opportunities for improvement, assessor will ensure that the statements are factual and agreed with lab Assessment team will determine whether finding is a nonconformity: –‘M’ – mandatory findings – action needed –‘R’ – recommendation

17. CPA is a UKAS company Assessment (5) Findings will be discussed at the time they are identified/recorded Potential corrective actions may also be discussed and specified Related findings can be combined (may assist in highlighting any gaps) Summary provided at closing meeting

18. CPA is a UKAS company Assessment Report UKAS reporting and assessment procedures are given in Lab 3 and Gen 3 (www.ukas.com) Main report prepared by Lead Assessor with input from all of the team Currently the report is structured around the following headings: Scope, Organisation, Management, Evaluation Processes, Technical Competence and Impartiality & Integrity

19. CPA is a UKAS company Next Steps Usual UKAS process: Recommendation Timescales for clearing findings Mechanism for clearing findings

20. CPA is a UKAS company What to expect… Scoping and hence coverage of the scope at the assessment Increased planning and up front preparation Different ‘routine’ in the assessment but plan will provide details Impact of the different requirements e.g. decreased focus on H&S Evidence based approach

21. CPA is a UKAS company What to expect….. Focussed discussions on key differences such as traceability, validation etc To demonstrate how you meet the requirements The assessment will focus on outcomes Assessment will seek to demonstrate that accreditation can be granted……remember what accreditation is expected to deliver

22. CPA is a UKAS company The Assessment Process 2014 Seminars