HKAS - Lead Assessor in ISO/IEC 17025 & ISO 15189 Exam
‘In addition to the requirements listed in 7.8.2, test reports shall, where necessary for the interpretation of the test result, include the following...’
For ISO 15189 only:
'There is a process for indicating the presence of sample interferences (e.g. haemolysis, icterus, lipaemia) that may alter the results of the examination...'
For ISO/IEC 17025 only:
‘Communication takes reading the effectiveness of the management system and the importance of meeting customer and other requirements...’
For ISO 15189 only:
'All laboratory staff shall have access to and be instructed on the use and application of the quality manual and the referenced documents...'
Which clause addresses this requirement?
At the Opening Meeting of a third party assessment, the Quality Manager of the audited organisation, informs the Assessor that a recent internal audit identified numerous deficiencies in the control of calibration, and that corrective action is being planned.
The Quality Manager proposes that the visit to the calibration department be deleted from the assessment program.
How should the Assessor respond?
During an accreditation assessment, a technician volunteers information that the laboratory often processes samples which come into the laboratory without the required identification.
The Quality Manager and the Laboratory Manager both immediately deny this, saying that this technician is a known trouble-maker and has a personal grudge against the Laboratory Manager following some disciplinary action taken a few weeks earlier.
What should the Assessor do in this situation?
Describe a minimum of five (5) pieces of objective evidence that could be available to verify compliance with the requirements of clause 8.3 in ISO/IEC 17025 and 4.3 in ISO 15189,
Quote the relevant clauses in your answer.
How and when will the assessment team inform the organisation of the assessment findings, throughout and following the assessment?
How will the findings be graded?
What do the different grades mean and what is the significance of each grade?
Microbiological Testing
Chemical Analysis
Environmental Testing
Quality and Calibration Group
Sample/Specimen Reception Group
Administration and Human Resources
- Carefully read each of the incidents on the following pages.
- Choose one (1) of the actions below, for each incident.
- Write your response, in the space provided below each incident scenario.
- Write the relevant heading for the action you are taking, in each of your responses.
- Click the 'Back' button to return to these instructions if you need.
- the area or activity audited
- the relevant Standard and Clause number
- a statement of the nonconformity, and
- your findings - the evidence on which the nonconformity is based.
- provide your reasons for this decision, and
- clearly state what further lines of investigation should be undertaken by the Assessor.
- Carefully read each of the incidents on the following pages.
- Choose one (1) of the actions below, for each incident.
- Write your response, in the space provided below each incident scenario.
- Write the relevant heading for the action you are taking, in each of your responses.
- Click the 'Back' button to return to these instructions if you need.
- the area or activity audited
- the relevant Standard and Clause number
- a statement of the nonconformity, and
- your findings - the evidence on which the nonconformity is based.
- provide your reasons for this decision, and
- clearly state what further lines of investigation should be undertaken by the Assessor.
In the sample receipt section of the laboratory, staff receive samples including those marked as urgent. Samples are accompanied by written customer requests and customer details. They enter this information in the database, then take the necessary action to ensure the sample is sent to the correct location for testing.
You are told by the Quality Manager that there are no written procedures or work instructions for these activities, as staff know from their training and experience what is required.
Respond with either: Action 1 (Nonconformity report) OR Action 2 (More investigation needed)
INCIDENT 2:
The management review record for laboratory XYZ includes an agenda item to review the quality policy for continuing suitability. The entry next to this item is ‘no action’.
On querying this with the Laboratory Manager, you are told that the quality policy is produced by the parent company. Although it is reviewed at the meeting, laboratory XYZ cannot alter it, hence the ‘no action’ comment. Other parts of the management review appear to have been completed fully.
Respond with either: Action 1 (Nonconformity report) OR Action 2 (More investigation needed).
INCIDENT 3:
During an assessment, the Laboratory Manager acknowledged that dimensional sensors in an automated testing machine currently in use were suffering from an intermittent fault.
According to records, this had been the case for some months. The machine was continuing to be used for testing prior to repair.
The Laboratory Manager told all staff to watch carefully for any anomalous dimensional readings obtained during these tests.
Respond with either: Action 1 (Nonconformity report) OR Action 2 (More investigation needed)