Quality Flashcards
What is a quality management system?
QMS
A system of organisational structures, procedures, responsibilities, and evaluation mechanisms which ensures the organisation is capable of delivering its service to specific standards.
What are the benefits of a QMS?
1, To improve and monitor the effectiveness of laboratory performance
2. Management: ensures the lab is efficiently organised and managed in a way which meets the service user’s needs.
3, To achieve standardisation
4. To achieve accreditation
What is QA?
Seeks to measure the processes and systems in order to reduce defective products
Quality assurance comprises of all the different measures taken to ensure the reliability of investigation and is not limited to the technical procedures carried out in the lab. Quality assurance is about getting it right first time i.e. preventing faults occurring consistently and by keeping all steps in the process under control.
What is quality control?
Seeks to measure the number of quality (requirements) of a product
This is the analysis of material of known content in order to determine in real time if the procedures are performing to the predetermined specifications. Good quality control is designed to prevent any faulty test results being reported but does not stop them occurring in the first place.
How does a QMS provide a mechanism for quality improvement?
- Internal Audits
- Key Quality Objectives
- Error logs / Incident reporting
- Complaints policy
- Document reviews
- Staff appraisal / Identification of training needs.
What ISO standards are important in the running of a genetics laboratory?
ISO15189 medical laboratories- requirements for quality and competence
ISO15189 is an ACCREDITATION
A formal recognition by an authoritative body (experts in the field) of the competence to work to specified standards
ISO9001 specifies the requirement for a quality management system
ISO9001 is a CERTIFICATION
Not competence- assessed by non-experts
Certification represents a written assurance by a third party of the conformity of a product, process or service to specified requirements.
What is UKAS?
The United Kingdom Accreditation Service is the sole national accreditation body recognised by the Government to assess, against internationally agreed standards, organisations that provide certification, testing, inspection and calibration services
What is GenQA?
It provides external quality assessment schemes to laboratories to test:
a) analytical & interpretive skills
b) quality of results
c) accuracy of reports
