UNDERSTANDING ISO/IEC 17025:2017

Implementing an ISO/IEC 17025:2017 laboratory quality management system is aimed at ensuring laboratory personnel safety & health in calibration and testing laboratories.

• True

• False

The Lab Quality Management System requirements when implemented for proper planning, for controlled performance of techniques, recording of all observations, monitoring of activities and archiving of all raw data can produce test results that are accurate, reliable and timely.

• True

• False

The main section in ISO/IEC 17025:2017 refers to ………..

• Structural mainly on organization structure

• Resource requirements on what is needed for good operation

• Management requirements related to the operation and effectiveness of the quality management system

• Process requirements

• All Of The Above

Job description is a mandatory requirement for management of laboratory staff in Lab Quality System under Clause 6.0 Resource Requirements.

• True

• False

Laboratory Quality System accreditation for MS ISO/IEC 17025:2017 is administered by “Skim Akreditasi Makmal Malaysia” or SAMM under SIRIM MALAYSIA.

• True

• False

Laboratory Quality System accreditation for MS ISO/IEC 17025:2017 by SAMM under SIRIM MALAYSIA involves three stages of audit process.

• True

• False

"Duties & responsibilities of all staff MUST be documented

Must be signed by the immediate Superior & staff

Updated at least once a year subjected to organizational changes

Written in an easy to understand and simple language"

The above statements refer to which of the following document in a Laboratory Quality Management System?

• Lab Quality Manual

• Lab Quality Policy

• Lab SOP

• Lab personnel Job Description (JD)

The annual training program/plan must be documented in SOP (“Standard Operating Procedure”) and developed using tools/techniques such as training needs analysis (TNA) or competency gap assessment.

• True

• False

Comparison of an item to a standard that is closer to SI, also known as a higher level standard. Third party laboratories will issue a certificate which is normally valid for a period of one year. Done by external third party service provider. A sticker is issued by the third party provider that is pasted on the equipment.

The above statements refer to which of the following activity in a Laboratory Quality Management System?

• Verification

• Calibration

• Preventive Maintenance

• Breakdown servicing & repair

Organization need to develop processes and establish documented procedure to control externally provided products and services. This control can be achieved by the following means EXCEPT ………

• Documenting the process in a SOP

• Supplier/Vendor Quality Survey Questionnaire

• Outgoing Finished Product Testing

• Supplier/Vendor Audit