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

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

"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?

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.

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?

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 ………

All test methods, lab procedures and supporting documentation, such as instructions, standards, manuals and reference data relevant to the laboratory activities, shall be kept up to date and shall be made readily available to relevant lab personnel in order to ensure smooth operation of lab activities.

Frequency based on equipment usage such as daily or weekly. Typically performed by internal lab personnel. No sticker is issued or pasted on equipment. Recorded manually in log book or in PC. 3-5 data per measurement for averaging.

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

Testing and calibration laboratories must maintain suitable temperature (20-24 deg C) and humidity (55%-65%) to protect the test sample, reagent, culture media and chemicals used.

Training record for lab personnel must also include assessment on effectiveness of training conducted such as _____________

The predominant topics that laboratory staff must be trained on is……..