For laboratory staff:

1. What are the requirements to become approved signatory in microbiology testing? (4m)

 Qualification and experience: (SC 1.3, Clause 5.2.6)

- Degree or higher in microbiology or related fields with one year or more laboratory
working experience in related fields requires 3 months working experience in current
laboratory; or less than one year laboratory working experience in related fields
requires 6 months working experience in current laboratory.
- Other requirements as stipulated in the relevant STR.
 Technical and operational requirements (SC 1.3, Clause 5.2.6)
- Requirements of MS ISO/IEC 17025 and related SAMM requirements and relevant
regulatory requirements.
- The principles of testing
- The standards, methods and specifications for accreditation sought or held
- The estimation of MU for the accreditation sought or held.
 Legal requirements. (SAMM Policy 6, Clause 5.1)
- Compliance with legal requirements shall be the sole responsibility of the signatory
and laboratory.
 Hold a position within the organization. (SAMM Policy 6, Clause 4.3)
 Specific exceptions at the discretion of Director of Accreditation. (SAMM Policy 6,
Clause 5.4)

2. You recently bought a new incubator for testing. Briefly explain the procedure for handling the
equipment in order to ensure it conforms to ISO/IEC 17025 requirements and laboratory
specified requirements. (10m)

 The lab shall have a procedure for handling, transport, storage, use and planned
maintenance of equipment. (MS ISO/IEC 17025:2017, Clause 6.4.3)
 The lab shall verify that equipment conforms to specified requirements before being
placed. (MS ISO/IEC 17025:2017, Clause 6.4.4)
 Records shall be retained. (MS ISO/IEC 17025:2017, Clause 6.4.13)
 Upon the receipt of equipment, the laboratory staff shall inspect and verify the
conformity of the equipment (LQP-6.4.1 Registration, Calibration & Maintenance of
Equipment, Clause 6.1.2)
 Take practicable measure to prevent unintended adjustments. (MS ISO/IEC 17025:2017,
Clause 6.4.12)
 Equipment shall be registered using F-6.4.2 Equipment Registration and Calibration Log.
(LQP-6.4.1 Registration, Calibration & Maintenance of Equipment, Clause 6.1.3)
 Equipment that requires calibration shall be calibration. (LQP-6.4.1 Registration,
Calibration & Maintenance of Equipment, Clause 6.1.4)
 Record the calibration, service and repair in the ‘Activity Log’ section of F-6.4.2 Equipment
Registration and Calibration Log. (LQP-6.4.1 Registration, Calibration & Maintenance of
Equipment, Clause 6.1.6)
 The Laboratory Executives or authorized personnel shall update the registered equipment
in F-6.4.1 Equipment Master List, including details of current location, equipment status,
person-in-charge (PIC), and calibration dates. (LQP-6.4.1 Registration, Calibration &
Maintenance of Equipment, Clause 6.1.7)
 Intermediate checks and equipment maintenance shall be performed. (LQP-6.4.1
Registration, Calibration & Maintenance of Equipment, Clause 6.4.1)
 The user shall record the intermediate check results in the respective forms of the
equipment. (LQP-6.4.1 Registration, Calibration & Maintenance of Equipment, Clause
6.4.3)
 3. The water bath in the laboratory has been shown to be defective. Explain the procedure to
handle the defective equipment. (6m)

 Taken out of service. It shall be isolated or clearly labelled or marked as being out of
service. (MS ISO/IEC 17025:2017, Clause 6.4.9)
 Initiate NC work procedure. (MS ISO/IEC 17025:2017, Clause 6.4.9)
 Solve the NC. Inform any affected customer.
 Verify that that equipment conforms to specified requirements before returned into service.
i.e. calibration/intermediate check.
 Remove ‘out of service’ label or put ‘fit for intended use’ label.
 Retain/update record on the equipment status/repair activity.

4. You notice that the staff did not follow the instruction stated in SOP. Describe how to solve
this matter and what documents are needed regarding to this issue. (10m)

 Issue NC
 Assess the risk, actions such as halting or repeating work are based upon the risk levels
established.
 Evaluation of NC including impact analysis.
 Solve the NC. Correction and corrective action.
 Verify if the NC is close effectively.
 Retain records of nonconforming work.
 Identify improvement

For business development executive:

1. Briefly describe LQP-7.1.1 Review of Requests, Tenders and Contracts. Also, please state
the form that you use to obtain customer feedback. (10m)

Summarize LQP-7.1.1
 2. Describe how would you handle customer’s complaint according to ISO/IEC 17025 Clause
7.9 and LQP-7.9 Handling of Complaints. (10m)

For all staff:

1. Describe Clause 8.3 Control of Management System Documents in ISO/IEC 17025. (8m)

 The lab shall control internal and external document

 The lab shall ensure that
- Documents are approved for adequacy prior to issue by authorized personnel.
- Documents are periodically reviewed and updated as necessary.
- Changes and the current revision status of documents are identified.
- Relevant versions of applicable documents are available at points of use and, where
necessary, their distribution is controlled.
- Documents are uniquely identified.
- The unintended use of obsolete documents is prevented, and suitable identification is
applied to them if they are retained for any purpose.

2. Briefly explain the procedure of evaluation of external providers adopted by Viroxy Sdn. Bhd.
It shall include the forms, documents that are needed to be kept. (10m)

3. Briefly describe Clause 7.8 Reporting of Results in ISO/IEC 17025. Also, please state the
general requirements of using SAMM Accreditation Symbol. (10m)
4. State what are the inputs shall be recorded in management reviews. (12m)