Accreditation Process (Week 2)

Question 1

1) Preparation

Answer 1

Lab needs to choose standard that applies to them - iso xx
Need to be familiar with standard
Look at whats already in place
Gap analysis - what else is needed?
Every test needs to be validated to be accredited

Question 2

1) Preparation 2.0

Answer 2

Quality manual sets out quality system;

 Scope of accreditation.
 Management and technical responsibilities.
 SOPs.
 Quality control measures.
 System of audit and review.

Question 3

1) preparation 3.0

Answer 3

Lab needs to show:

 Full documentation of procedure.
 Documentation showing sample traceability.
 Evidence and records of calibration.
 Data demonstrating method validation.
 Evaluation of measurement uncertainty.
 Evidence of qualified and trained staff.
 Effective programme for quality control of data.

Question 4

2) Application

Answer 4

Complete application to UKAS
Supply appropriate materials - eg quality policy
UKAS Will appoint accreditation and assessment manager
Around 3 months between application and assessment visit

Question 5

3) Pre assessment

Answer 5

Optional - can be benficial
Costs money
Informal visit - assesses if you are ready for accreditation
Can identify areas of weakness
Ensures lab doesn’t put itself ahead to quickly - can save application costs

Question 6

4) Assessment visit

Answer 6

Formal lab assessment 
Conducted by lead assessor 
Covers:
Impartiality of lab
Technical competance of staff, equipment, environment, validity of test methods 
Effectiveness of managemnt system

Lead assessors lookd at higher level QM procedure
Technical asessors look at validation documents, require atleast 5 years of experience

Question 7

4) Assessment visit 2.0

Answer 7

How lead and technical assessors undertake assessment:
Check records - QMS, training, Equpment - maintenance, calibration records
Observe work
Ask questions to staff to check understanding of QMS

Vertical audits - look at everything, samples from receipts at labs, examinations of items, analysis, reporting of findings

Horizontal audit - review a theme - calibrations, training records

Question 8

4) Assessment visit 3.0

Answer 8

End of visit:
Details of improvements, corrective actions, non confirmances (could stop you working)
Timescales for completing will be agreed
Recommendations will be made
Full report with findings, actions, recommendations issued in a few days

Question 9

5) Post assessment

Answer 9

Lab must complete outstanding actions - provide evidence
When all actions cleared - assessment manager will make recommendations to an independent decision maker
Accreditation certificate will br issued if ratified - publically available on UKAS

Question 10

What happens after lab is accredited?

Answer 10

Yearly surveillance visit
Full re assessment every 4th year
Further tests could be added via extension to scope at any time - eg changing equipment, tests

Question 11

Costs?

Answer 11

Small lab:
Application- £1500
Assessment- £9200
Surveillance - £5300 for 3 years 
Reassessment- £7400

Total - £23,400