Quality Management System (QMS)

Need to finish

What is a quality management system (QMS)?

A method for maintaining and improving quality in line with customer needs

Is a QMS only applicable to laboratories?

No. It can be applied to any process

What is the overall purpose of QMS?

To maintaim and improve quality while meeting customer needs

What are the major components of quality management covered in the lecture?

• Quality standards

• Quality Laboratory Processes/Procedures

• Quality Control

• Quality Assessment

• Quality Improvement

What are quality standards?

The goals of a QMS and the requirements that need to be achieved to satisfy customer needs

What is the role of quality standards in a QMS?

They are core to the whole QMS and establish the goals that quality processes aim to achieve

What are the two important quality standards for a laboratory?

The laboratory should:

1. provide correct results

2. Provide results within the expected time frame

What is the relationship between quality standards and customer needs?

Quality standards define the requirements that must be achieved to satisfy the csustomers needs

What is quality planning?

Establishing and validating processes that meet customer needs

What are examples of quality planning in a laboratory?

• Selecting new procedures

• Selecting new machines/equipment

• Selecting and designing QC procedures

What is quality planning important?

It ensures that laboratory processes are established and validated to meet customer needs

What are quality laboratory processes?

The policies, procedures, personnel standards and physical resources that determine how work gets done

Quality laboratory processes are another way of descriving what?

Quality Assurance (QA)W

What is Quality Assurance (QA)

The systems, processes and standards put in place to ensure work is performed correctly and consistently

What are examples of QA in a laboratory?

• Quality manual

• SOPs

• personnel training

• Equipment standards

What does SOP stand for?

Standard operating procedure

Why are personnel training and equipment standards part of QA?

They establish standards for how work is performed and help ensure processes are carried out consistently.

What is Quality Control (QC)?

Procedures used to monitor work processes, detect problems and make corrections before products or services are delivered

What are the three key functions of QC?

1. Monitor work processes

2. detect problems

3. Correct problems before delivery

Give examples of QC in a laboratory

• Statistical QC for machines

• Monitoring reagent inventory

• Monitoring sample storage conditions

• Verification of atypical patient results

What is the main difference between QA and QC

QA = systems and processes designed to ensure quality

QC = monitoring those processes to detect and correct problems

What is quality assessment?

The broader measurement of other dimensions associated with quality and client requirements

What areas can be assessed in a laboratory?

• Sample acquisition

• Data entry

• Turnaround time

• Reporting ability/appropriateness

What does turnaround time refer to in laboratory quality assessment?

The time taken for the laboratory process/results to be completed and reported

Why is sample acquisition included in quality assessment?

Because the quality of the overall laboratory process depends on appropriate sample acquisition

What is the purpose of quality improvement?

To determine the causes/sources of problems identified by QA/QC

Who investigates quality problems?

People or teams responsible for investigating noted or potential problems

What analysis is performed during quality improvement?

Root cause analysis

What happens after root cause analysis?

Future preventative actions are developed

Where dose quality improvement feed back into?

Quality planning

What organisations/standards are mentioned in relation to laboratory quality accreditation and certification?

NATA and ISO

What does accreditation/certification involve?

Rigorous external assessment of laboratory quality