QMS & ISO Awareness

The rationale for implementing an overall quality management system in the laboratory is to

• help to ensure that testing performed by the

  laboratory is accurate and reliable

• prevent any possibility of testing error

• differentiate between qualitative and

  quantitative methods

• prevent potential errors in the laboratory’s path

  of workflow

The standard that applies specifically to quality in the clinical laboratory is:

• ISO 15189

• ISO 15188

• ISO 9001

• ISO 17025

When are written procedures required?

• Whenever a job holder is going on vacation

• Whenever a process is put in place

• Only when the job holder does not understand

  his job

• Any of the above situation arises

Service quality cannot be managed when

• No vendors are involved

• Workers don't meet regularly with management

• Customer expectations are not known

• Consultants are not consulted

Which of the items below are benefits of Quality Management System? Select all that apply.

• Reduction in mistakes

• Process improvements

• Increases overtime

• Customer satisfaction will increase

Our Laboratory Quality Manual (QM001) is designed mainly based on ISO 15189 standard

requirements. True or False?

• True

• False