2023 HKAS Lead Assessor Exam - ISO/IEC 17025
‘Communication takes reading the effectiveness of the management system and the importance of meeting customer and other requirements...’
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.
Quote the relevant clauses in your answer.
You are conducting a third party assessment.
The next item on your audit program is a meeting with the Purchasing Manager and Laboratory Manager to discuss selection of suppliers; purchasing and receipt of equipment, services and consumables; and management of the inventory control database.
Detail what you would include in your checklist to guide you through this part of the assessment, and state the relevant clauses in the Standard.
In a large construction materials testing laboratory, there are a number of vernier calipers, balances, hydrometers and pH meters.
The instruments are regularly checked and calibrated.
Describe the objective evidence that should be available to demonstrate compliance with clauses 6.4 and 6.5 of ISO/IEC 17025.
State the relevant clauses in the Standard, in your answer.
You have had an enquiry regarding accreditation to ISO/IEC 17025 from a commercial testing laboratory.
The laboratory has established a quality system and employs more than 60 people in the following departments:
- Microbiological Testing
- Chemical Analysis
- Environmental Testing
- Quality & Calibration Group
- Sample/Specimen Reception Group
- Administration & Human Resources
Describe the specific activities and tasks you would carry out before going into the entry meeting of the initial assessment.
Indicate the order of these activities and outline what each activity requires.
- 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)