ISO 15189 Flashcards
What is the id number for the current version
ISO 15189:2022 Standard
what does the ISO 15189 Show? and when was it first published - include revision republishent dates
shows requirements for quality and competence of medical labs
- first published 2003, republished - 2007, 2012, 2022
how are irish labs accredited
INAB accredits Irish labs according to ISO 15189
What does shall, should and may mean in this document. how many pages are the requirements and total document
it means its a requirement, its a recommendation and its permitted
-requirements = 34 pgs
-total -64
what are the subsections of this document
- SCOPE
- NORMATIVE REFERENCES
- TERMS + DEFINTIONS
- GENERAL REQUIREMENTS
- STRUCTURAL + GOVERNANCE REQUIREMENTS
- RESOURCES REQUIREMENTS
- PROCESS REQUIREMENTS
- MANAGEMENT SYSTEMS REQUIREMENTS
- Annexure -A. POCT B. Comparision with ISO 9001: 2015; ISO 17025: 2017 C ISO 15189: 202
what is the main objective of the ISO 15189
- Promote welfare of patients + and satisfaction of lab users through confidence in the quality and competence of medical labs
the document shows the requirements for the med lab to plan and implement what?
actions to address risks and opportunities for improvement - no more 0 tolerance some things can be tolerated - hence risk assessment must be done on everything
what are the benefits of the new some tolerance approach of the new standard
increase effectiveness of the management system, decreasing probability of invalid results, reduce potential harm -> patients, lab personel, the public and the environment
medical lab responsibility in relation to the patient
activities should done in timely manner and needs of all patients and personnel responsible for patient should be met
what does clause 4 entail and list its first 3 subsections
General requirements
4.1. lab activites undertake impartially
4.2 confidentiality
4.3 requirements regarding patients
what does clause 4.1 cover
the lab activites undertaken impartially meaning the lab is structured and managed to safeguard impartiality
clause 4.2 entails
confidentiality - 4.2.1. management of info obtained
4.2.2 release of info
4.2.3 personnel responsibility
what does clause 4.3 entail
requirements regarding patients
- Lab management shall ensure that patients well-being, safety + rights are the primary consideratiosn
- Lab implement processes a-> I in ISO 15189
- E- treat patients, sample with due care and respect i.e. proper disposal
H- making info available
what is a NC and a NCR
non-conformities as defined by ISO standard is the nonfulfillment of requirements and therefore is when a purpose/ activity has not fulfilled it intended use
what is the difference between quality policy and quality manual
QP- defines intent use for the QMS and ensures its appropriate for its intended purpose
QM incorporates the QP/references it - it describes the scope, structure and relationship of documents used in QMS
Explain difference between Ca and Pa
corrective action- action to eliminate the root cause of the problem causing a Non-conformity. Preventive action- proactive process used -> identify opportunities for improvement
CLAUSE 5 OF THE ISO 15189 COVERS? lsit first 4 subsections
Structural and government requirements
5.1 legal entity
5.2 lab director
5.3 General
5.4 Structure and authority
describe clause 5.1
Legal entity
- Lab can be held legally responsible
explain clause 5.2
Lab director - has ultimate responsibility, they implement the management systems, risk management [patients risk and opportunities -> improve
explain 5.3 and all it entail
Lab Activities
5.3.1 General
- Range of lab activitives
- Include activities @ sites other than main location i.e. POCT and sample collection
5.3.3 Advisory Activities
- Appropriate advice + interpretations = available + meet needs of aptients and users
- –Lab establish arrangements for communicating with users e.g.g - choice + use of examinations [sample type, clinical indications, limitation of examinantion methods]
- –advise on failure of samples -> meet acceptability criteria [i.e. tell doctor when look for a next step test how to label bottle to ensure sample doesn’t fail and is rejected
explain 5.4 and all it entails?
General
Organisation and management structure should be defined in a lab
Should define place in any parent organisation
Defien relationships between management, technical operations and support services
Specify respon. Authority, lines of communication + interrelations of all personnel
effective leadership and management on practice results in what?
success is achieved and better patient care
the organisation structure must ?
assure quality goals
list 4 benefits of leadership and management on practice
- improve staff morale
- increase productivity
- promotes quality care
- improves financial performance
what is clinical government and what is there importance
is a framework through which healthcare teams are accountable for quality, safety and satisfaction of patients they deliver care to. helps ensure people receive care they need in a safe, nurturing and open + just environment which arises from corporate accountability for clinical performance
what is the role of clinical
ensures a culture + commitment to agreed service levels and quality of care to be provided
benefits of clinicial governance
improved patient experiences + better health outcomes in terms of quality and safety
what role do lab results play in clinical decision making
diagnosis, prognosis and monitoring
what are the principles of conflict management - CARE
C- Communicate
A- actively listen
R- review options
E- end with a win-win sitch
What does clause 5.5 cover
objectives and policies —- policies are established and maintained to: 1. Meet needs + requirements of its patients + users
2. Commit -> good profess
3. provisional practice
4. Provide examinations that fufill their intended use
5. Conform -> ISO 15189:2022
- Shall be measurable [i.e. rejected samples -. Those received TAT
- Establish quality indicators to evaluate performance
[pre-examination, examination and post examination processes
what does clause 5.6 entail and how is its titled achieved
risk management maintain processes
- Identify risks of harm to patients
- Opportunities for improved patient care
what does ISO 22367 detail and what does ISO 35001 entail
provide details for managing risk to med labs
35001 gives details for lab biorisk management
CLAUSE 8 covers ? name first 5
managment system requirements
8.1 general
8.2 management system documentation
8.2 control of management system documents
8.3 control of records
8.5 actions to address risks and opportunities for improvement
describe clause 8.2 and what it does
MANAGEMENT SYSTEM DOCUMENTATION
- Establish document, implement and maintain a management system [QMS]
- Persons doing work under lab control = aware of :
1. Relevant objectives and policies
2. Their contribution -> effectiveness pf QMS including benefits of improved performance
Consequences of not conforming with QMS requirements
describe clause 8.3 and what it entails
CONTROL OF MANAGEMENT SYSTEM DOCUMENTS
Document: is editable and communicates info
Policy statements, procedures + related job aids, flow charts, instructions for use, specification, manufacturer’s instructions, calibration tables,
HOW ARE INTERNAL AND EXTERNAL DOCUMENTS CONTROLED
- uniquely identified
-documents = approved for adequacy by expertise, authorized and competent personnel - documents = periodically updated and reviews
- relevant versions = available @ points of use [distribution control = put in place when necessary
-changes + current revision status = identified
-documents = protected from unauthorized access
-unintended use of out of date documents = prevented + suitable id = put on them if they are retained for any reason - @ least 1 paper/electronic copy of each out of date/obsolete of document = retained for specified time period
control of records facts x6
- Are created @ time of activity.
- Uneditable
- Retained - retention times specified#
- Establish and retain legible records
- Records must be accessible, legible or available for review
- In any form or type of Medium
procedures are implemented for? records
- ID
- storage
- protection form unauthorised use
- back-up
-archive
-retrieval - Tr
disposal of records
management reviews occurs when
@ planned intervals- it reviews the management system
list review inputs
- meeting minutes actions
- objective + suitability of policy and procedures
-inspections i.e. trend analysis
-user feedback -complaints
-risk and opportunities for improvement
-vendor review
-external quality assurance
-departmental statistics
how are the outputs reviews
a record of the decisions / actions are made - check and ensure actions = completed within specified time frame
-communicate actions and decisions to all lab personnel
