ISO/IEC 17025:2017 LMS Requirements (Part 2)

The lab personnel review the test request to confirm the belows. (Multiple answers)

• Available of competent personnel to conduct the test.

• Available of equipment and required chemicals/ reagent to perform the test.

• Test method used is suitable and compatible for type of sample matrix received.

• Opportunity to expand the business territory.

Methodologies for method validation. (Multiple answers)

• Selectivity and specificity

• Repeatability of test

• Reproducibility of test such as proficiency testing and interlab comparison

• Spiked sample and recovery test

Purposes of sample identification and labeling/ marked? (Multiple answers)

• Unique to the specific test item only.

• Traceble from the test item itself to its applicable analysis worksheet, logbook and Test Report.

• Nice design

When a data or test result is wrongly written...

• Erase it

• Use correction pen to correct it

• Cross it, then the correct data/ value entered alongside and initialed by the person making the correction

Why we need to duplicate / replicate the testing? (Multiple answers)

• Enhance result confident.

• Detect outliers

• More result options

• Justify whether to accept or reject the test result or repeat the testing

Purposes of Quality Control (QC) Chart. (Multiple answers)

• To monitor the trend of test result (result distributions)

• To monitor the test result obtained whether within the acceptance criteria (mean + 2SD and mean - 2SD)

• For record and drawing purposes

What is Proficiency Testing (PT)?

• Same batch of test item distributed to all participated laboratories to carry out the testing within the same period

• Result comparison within the participated laboratories

• Result evaluation whether within the satisfactory range / z-score

• Indicate laboratory's overall performance, equipment performance, test performance and personnel performance

The laboratory shall keep the technical records for a minimum of ...

• 3 years

• 7 years

• 6 years

• 5 years

Document control procedure consists of... (Multiple answers)

• Review and approve prior distributed

• Identified with document title, document number, revision number and effective date

• Retained obsolete copy are suitable marked with "OBSOLETE"

• Document Master List to overview the availbility of documents and its current revision status

Outputs from internal audit... (Multiple answers)

• Audit plan / schedule

• Report of audit findings, evidence and observation

• Non-Conformity Report (NCR)