19.07.02 quality management

Question 1

Define Quality management system (QMS)

Answer 1

A set of co-ordinated activities to direct and control an organisation in order to continually improve the effectiveness and efficiency of its performance.

Question 2

Purpose of QMS

Answer 2

Improves and monitors the effectiveness of performance to safeguard companies and their users.

Question 3

What is Q-pulse

Answer 3

Software that aids and fufils the requirements of QMS.

Question 4

What does the quality policy contain

Answer 4

Outlines the commitments to meeting needs and requirements of users

Question 5

What does the quality manunal contain

Answer 5

List of key policies and procedures for managing the organisation and its work processes.

Question 6

What are the main Good laboratory practices (GLPs)

Answer 6

• Resource optimisation
• People, environment and experimentation animals’ protection
• Establishment of standardised operating methods
• Guarantee the quality and reproducibility of study results

Question 7

What does ISO stand for

Answer 7

International organisation for standardisation

Question 8

What are ISO standards

Answer 8

Voluntary standards (although becoming a market requirement). No legal authority to enforce implementation of standards

Question 9

What ISO standards are relevant to labs

Answer 9

• ISO 9000:2015= Quality management systems- Fundamental concepts and principles of quality management
• ISO 9001:2015=Quality management systems- requirements
• ISO15189:2012= Medical laboratories- requirements for quality and competence.

Question 10

external quality assurance benefits:

Answer 10

• Method validation
• Comparing results with other labs
• testing problem identification
• Accreditation requirement
• Lab credibility

Question 11

UKNEQAS

Answer 11

Now GenQA (Genomics Quality Assessment) = provides a quality assurance service for genomic labs. Assesses the quality of analytical and interpretative performances

Question 12

Internal quality assurance (IQA)

Answer 12

Usually done by auditing. Vertical, horizontal, clinical, examination.

Question 13

Review of ISO 15189:2012

Answer 13

• Globally recognised standard specific for medical laboratories
• Focus on patient care and safety by reducing operational risks and maintaining efficiencies.
• Sets out standards for quality management
• Demonstrates to users and patients the quality and reliability of the diagnostic services.
• Full assessment every 4 years. Annual surveillance visits between this.
• Labs need to deomnstrate continual assessment and improvement of quality, demonstrating they are addressing areas of non-conformance.
• 2 parts: technical and management competence