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Quality Managment > ISO 15189 > Flashcards

ISO 15189 Flashcards

1
Q

What is the id number for the current version

A

ISO 15189:2022 Standard

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2
Q

what does the ISO 15189 Show? and when was it first published - include revision republishent dates

A

shows requirements for quality and competence of medical labs
- first published 2003, republished - 2007, 2012, 2022

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3
Q

how are irish labs accredited

A

INAB accredits Irish labs according to ISO 15189

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4
Q

What does shall, should and may mean in this document. how many pages are the requirements and total document

A

it means its a requirement, its a recommendation and its permitted
-requirements = 34 pgs
-total -64

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5
Q

what are the subsections of this document

A
  1. SCOPE
    1. NORMATIVE REFERENCES
    2. TERMS + DEFINTIONS
    3. GENERAL REQUIREMENTS
    4. STRUCTURAL + GOVERNANCE REQUIREMENTS
    5. RESOURCES REQUIREMENTS
    6. PROCESS REQUIREMENTS
    7. MANAGEMENT SYSTEMS REQUIREMENTS
  2. Annexure -A. POCT B. Comparision with ISO 9001: 2015; ISO 17025: 2017 C ISO 15189: 202
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6
Q

what is the main objective of the ISO 15189

A
  • Promote welfare of patients + and satisfaction of lab users through confidence in the quality and competence of medical labs
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7
Q

the document shows the requirements for the med lab to plan and implement what?

A

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

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8
Q

what are the benefits of the new some tolerance approach of the new standard

A

increase effectiveness of the management system, decreasing probability of invalid results, reduce potential harm -> patients, lab personel, the public and the environment

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9
Q

medical lab responsibility in relation to the patient

A

activities should done in timely manner and needs of all patients and personnel responsible for patient should be met

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10
Q

what does clause 4 entail and list its first 3 subsections

A

General requirements
4.1. lab activites undertake impartially
4.2 confidentiality
4.3 requirements regarding patients

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10
Q
A
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11
Q

what does clause 4.1 cover

A

the lab activites undertaken impartially meaning the lab is structured and managed to safeguard impartiality

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12
Q

clause 4.2 entails

A

confidentiality - 4.2.1. management of info obtained
4.2.2 release of info
4.2.3 personnel responsibility

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13
Q

what does clause 4.3 entail

A

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

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14
Q

what is a NC and a NCR

A

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

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15
Q

what is the difference between quality policy and quality manual

A

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

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16
Q

Explain difference between Ca and Pa

A

corrective action- action to eliminate the root cause of the problem causing a Non-conformity. Preventive action- proactive process used -> identify opportunities for improvement

17
Q

CLAUSE 5 OF THE ISO 15189 COVERS? lsit first 4 subsections

A

Structural and government requirements
5.1 legal entity
5.2 lab director
5.3 General
5.4 Structure and authority

18
Q

describe clause 5.1

A

Legal entity
- Lab can be held legally responsible

19
Q

explain clause 5.2

A

Lab director - has ultimate responsibility, they implement the management systems, risk management [patients risk and opportunities -> improve

20
Q

explain 5.3 and all it entail

A

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

21
Q

explain 5.4 and all it entails?

A

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

22
Q

effective leadership and management on practice results in what?

A

success is achieved and better patient care

23
Q

the organisation structure must ?

A

assure quality goals

24
Q

list 4 benefits of leadership and management on practice

A
  1. improve staff morale
  2. increase productivity
  3. promotes quality care
  4. improves financial performance
25
Q

what is clinical government and what is there importance

A

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

26
Q

what is the role of clinical

A

ensures a culture + commitment to agreed service levels and quality of care to be provided

27
Q

benefits of clinicial governance

A

improved patient experiences + better health outcomes in terms of quality and safety

28
Q

what role do lab results play in clinical decision making

A

diagnosis, prognosis and monitoring

29
Q

what are the principles of conflict management - CARE

A

C- Communicate
A- actively listen
R- review options
E- end with a win-win sitch

30
Q

What does clause 5.5 cover

A

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

31
Q

what does clause 5.6 entail and how is its titled achieved

A

risk management maintain processes
- Identify risks of harm to patients
- Opportunities for improved patient care

32
Q

what does ISO 22367 detail and what does ISO 35001 entail

A

provide details for managing risk to med labs
35001 gives details for lab biorisk management

33
Q

CLAUSE 8 covers ? name first 5

A

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

34
Q

describe clause 8.2 and what it does

A

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

35
Q

describe clause 8.3 and what it entails

A

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,

36
Q

HOW ARE INTERNAL AND EXTERNAL DOCUMENTS CONTROLED

A
  • 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
37
Q

control of records facts x6

A
  • 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
38
Q

procedures are implemented for? records

A
  • ID
  • storage
  • protection form unauthorised use
  • back-up
    -archive
    -retrieval
  • Tr
    disposal of records
39
Q

management reviews occurs when

A

@ planned intervals- it reviews the management system

40
Q

list review inputs

A
  • 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
41
Q

how are the outputs reviews

A

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

Quality Managment (2 decks)

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