VERTICAL ASSESSMENT MEDICAL LABORATORIES

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

• Date of Assessment:

• Assessor

• Laboratory

• Laboratory Representative.

• Area/Field of operation

Certificate or Report

• Select one or more final report/certificate. Record at least the number, date and accredited parameters, measured.

• Notes:

• REQUIREMENTS AND COMMENTS.NB. Indicate WHAT has been checked and HOW requirements have been implemented.

Technical Records (state which data and calculations were checked)

• 5.4.7 Raw data/original observations, calculations, derivations

  Yes

  No

  N/A

• 5.4.10 Traceability to the performing Technologist and authorizing personnel

  Yes

  No

  N/A

• 4.13.2 Records permanent, corrections legible and authorized

  Yes

  No

  N/A

• Laboratory's control checks appropriate / effective

  Yes

  No

  N/A

• Appropriate calculation checks/correctness of data transfers/laboratory's control checks appropriate and effective

  Yes

  No

  N/A

5.1 Training (check training records)

• 5.1.7 Technologists identified as competent for the work? Proof of competence available?<br>Proven competent at the time the work was performed.

  Yes

  No

  N/A

• 5.1.11 Appropriate method of determination of competence?

  Yes

  No

  N/A

5.5 Performance capability of selected methods

• 5.5.1 Proof of confirmation of - standard methods, laboratory developed methods, non-standard method?

  Yes

  No

  N/A

• 5.5.2 Methods validated and availability of performance capability

  Yes

  No

  N/A

• Method uncertainty or specification tolerances

  Yes

  No

  N/A

• 5.5.6 Documented procedure available at the work station?

  Yes

  No

  N/A

5.6 Assurance of validity of results

• How does the Laboratory monitor results?

  Yes

  No

  N/A

• Monitoring data suitably recorded (E.g control charts) evaluated reviewed?<br>Effective control limits or tolerances established?

  Yes

  No

  N/A

• Evidence of actions implemented when breaches have occurred ?

  Yes

  No

  N/A

5.6.4-7 Proficiency Testing/Inter laboratory comparisons

• Evaluate the appropriateness for the work performed<br>Evaluate results-action on anomalies.

  Yes

  No

  N/A

5.3 Calibration of equipment or standards used

• 5.3.2/5.3.9/5.3.13- operating range covered,calibration status,records of calibration complete

  Yes

  No

  N/A

• Traceability to National standards, traceability to appropriate measurement standards

  Yes

  No

  N/A

• 5.6.3 Reference Standards

  Yes

  No

  N/A

5.3 Equipment maintenance and operation

• 5.3.5 & 6 Instructions for use and maintenance?

  Yes

  No

  N/A

• 5.3.4 Records complete

  Yes

  No

  N/A

• 5.3.12 Handling/transport/storage/use to prevent contamination/deterioration of equipment and std. /reference materials

  Yes

  No

  N/A

5.2 Accommodation and environmental conditions

• 5.2.4 -5.2.9

  Yes

  No

  N/A

4.6 Purchasing of supplies

• Verified before use

  Yes

  No

  N/A

• 4.6.3 inventory control system

  Yes

  No

  N/A

• 4.6.4 Suppliers evaluated

  Yes

  No

  N/A

5.4.5-14 Handling of test items

5.8 Reporting the results