Stepwise Phases For Quality Management Systems … · 2020. 11. 16. · QMS Implementation for Laboratories Training for Sustainable Laboratory Development In Resource-Limited Environments

QMS Implementation for Laboratories

Training for Sustainable Laboratory Development

In Resource-Limited Environments

Stepwise Phases

For

Quality Management Systems

Implementation

and

Preparation for Accreditation

In Medical Laboratories

Prepared by

Valerie Wilson & Wendy Kitson-Piggott July 2010


QMS Implementation Stepwise Phases

Resource-Limited Environments V. Wilson & W. Kitson-Piggott, July 2010

2

TABLE OF CONTENTS

EXECUTIVE SUMMARY 3 1.0 INTRODUCTION 4 2.0 ISSUES CRITICAL TO QMS IMPLEMENTATION SUCCESS 5 3.0 STRATEGIC PLANNING FOR MEDICAL 7

LABORATORIES 4.0 QMS IMPLEMENTATION PROCESS 7

4.1 Quality System Essentials 4.2 Quality Processes 4.3 Gap Assessments and QI Plans 4.4 QMS Documentation

5.0 MODELS FOR PHASING OF QMS IMPLEMENTATION 10

5.1 Thailand Model 5.2 WHO Accreditation Process 5.3 Canadian Model

6.0 SUGGESTED PHASES AND REQUIREMENTS OF

THE STANDARD 12 7.0 IMPLEMENTATION STRATEGY 13

8.0 REFERENCES 14

APPENDICES 15 APPENDIX 1: Phases for Medical Lab QMS Implementation 15 APPENDIX 2: Lab Strengthening Checklist for Medical 25 Laboratories




3

STEPWISE PHASES FOR QMS IMPLEMENTATION AND PREPARATION FOR ACCREDITATION

EXECUTIVE SUMMARY The implementation of QMS within laboratories in developing countries takes place within the context of a laboratory sector that is challenged in most instances by lack of adequate resources – both human and financial, lack of adequate knowledge of QMS requirements by laboratory and key administrative staff, limitations of physical and equipment infrastructure and of procurement systems, inadequate equipment maintenance systems and services, lack of regulation of the laboratory sector and lack of or very limited evidence base for policy decision-making. The process which should be implemented to ensure QMS implementation in a sustainable manner within these environments must include tools and mechanisms for evaluation of phases and an award process to reward and encourage progress. The natural hierarchy of QMS building is suggested as the basis for developing the phases for QMS implementation. The rationale behind the suggested phases is based on the way in which documentation and implementation should logically progress. The process for implementation of this phased QMS building programme includes:

• Development of a national laboratory network or individual laboratory strategic plan for medical laboratory services (including as a basis an overall assessment of the current situation with respect to medical laboratory services).

• Signature of an administrative MOU for phased implementation of medicial laboratory services including QMS, between the expert agency/organization and the Ministry of Health (MOH).

• Conduct of a gap analysis by expert agency consultants to determine the extent of current QMS implementation and to assign a baseline for the intervention.

• Development of a Quality Improvement Plan (CQI plan) – Phase 1 with indicators, means of verification, timelines and roles and responsibilities.

• At the end of Phase 1, conduct of an evaluation experts/consultants.

• Based on this assessment the level of implementation of laboratory quality systems can be estimated. Laboratory services achieving their Phase 1 plan can be given recognition by the expert agency for having achieved Phase 1, and a plan for implementation of Phase 2 can be developed.

• A remedial plan with timelines should be developed for laboratories not achieving their Phase 1 plan to address non-conformities.




4

Through the above process, laboratories can be supported and encouraged through recognition to move progressively from Phase 1 to Phase 3 of QMS implementation and thus to ready themselves for accreditation. 1.0 INTRODUCTION The US President’s Emergency Plan for AIDS Relief (PEPFAR) has mobilized and committed significant resources to fight HIV/AIDS globally and more recently, has included TB and malaria interventions. The PEPFAR initiative is committed, inter alia, to the strengthening of laboratory systems in resource-poor countries with focus on the development of national strategic plans for laboratory network development and the building of sustainable and integrated in-country networks. Within the Caribbean, the implementation of the PEPFAR Laboratory Strengthening initiative follows the successful implementation by the Caribbean Epidemiology Centre’s European Union funded project for laboratory strengthening which resulted in adoption of the ISO 15189 as the Standard for medical laboratories, establishment of a regional accreditation mechanism, and training of laboratory managers and staff to implement quality systems. The implementation of quality management systems (QMS) within participating laboratories is fundamental to delivery of reliable laboratory services and therefore to the PEPFAR initiative. Laboratories in many developing countries have adopted the ISO 15189 or other Standards for ensuring quality of service, often with a view to achieving accreditation on full implementation of the Standard. In order to support laboratories in this implementation process, CQA and CMLF have undertaken the development of a phased system for quality management systems building that will provide laboratories with guidance for progressively implementing their QMS as well as a mechanism for evaluating and signing off on their progress. This document has therefore been developed to meet the following objectives:

a. Identification of the requirements of the Standard to be achieved in each Phase

b. Development of tools and mechanism for evaluating and signing off on completion of each phase

c. Recommendations for a monitoring, evaluation and award system 2.0 ISSUES CRITICAL TO QMS IMPLEMENTATION SUCCESS Quality within any environment or discipline, at the organizational, national or international level, is the product of the interaction between evidence-based policy, organizational infrastructure (including the wider organization), professionalism (competence, ethics, etc.) and practice (Figure 1).




5

Fig 1: Quality and the Environment in which it exists The implementation of QMS within laboratories in developing countries takes place within the context of a laboratory sector that is challenged in most instances by:

• Lack of adequate resources – both human and financial

• Lack of adequate knowledge of QMS requirements by laboratory and key administrative staff

• Limitations of physical and equipment infrastructure

• Inadequate procurement systems that result in significant lack of reliability of service delivery

• Inadequate equipment maintenance systems and services

• Lack of regulation of the laboratory sector

• Lack of or very limited evidence base for policy decision-making. Given the reality of such environments, sustainable QMS implementation must include interventions that seek to build the supportive environment in addition to building QMS within the laboratories. Such a sustainable QMS intervention therefore should include:




6

1. Strategic planning for the national laboratory network or the individual laboratory, based on analysis of the current situation and the vision for laboratory services. This plan serves as the overall roadmap for development of the laboratory sector (or individual laboratory), including the building of QMS.

2. Establishment of a Quality Manager and Management Review Team to drive, support and oversee the quality initiative within the laboratory.

3. Sensitization and building of awareness among laboratory staff and management including management of the parent organization to ensure the generation of the required support, both internal and external to the laboratory.

4. Training of staff to implement quality systems through design and implementation of a structured training plan and programme.

5. Conduct of a baseline gap analysis against requirements of the agreed Standard to determine existing gaps.

6. Development of QMS documentation to meet the requirements of the Standard i.e. policies, procedures and records, the latter providing evidence of implementation.

7. Integration of QMS as the framework for laboratory operations on a daily basis. This requires that laboratory staff, supervisors and management gather and utilize QMS data an ongoing basis for monitoring implementation and for conducting continual improvement. Such monitoring is achieved through ongoing assessment of laboratory quality control and quality assurance, internal and external audits, customer feedback and establishment and monitoring of quality indicators.




7

3.0 STRATEGIC PLANNING FOR MEDICAL LABORATORIES

Effective planning for medical laboratory services is key to the provision of a relevant, timely, quality service, with high quality information being provided to all stakeholders. In the first instance, the level, type and location of service(s) required must be determined through a strategic planning process. There are many factors that need to be taken into account, including the political climate, national health objectives, geography and environment, technical realities, epidemiological situation and human and financial resources. Client need, cost-effectiveness, accessibility and affordability of services are key considerations. Assessing these factors and their impact on service needs and delivery, provide a guide to the size, scope and location of laboratory services required, as well as the selection of suitable staff and the quantity and type of equipment, reagents and supplies needed to ensure continuous service provision. At a national level, Medical laboratory services may include the following categories of service:

• Near Patient Services o Point of Care Testing (POCT) o Peripheral Labs/Health Centres

• District and Regional Laboratory Service o Hospital Laboratory Services at district and regional levels

• National Public Health Laboratory Service o Reference Laboratory Service o Specialist Laboratory Service

A strategic plan for the national laboratory network (or the individual laboratory service) ensures that laboratory service development, including QMS implementation, takes place in an organized, cohesive and comprehensive manner. Including key stakeholders in the planning process serves to ensure that their views and needs are taken into account and that their support and partnership is secured for implementation of the plan. 4.0 QMS IMPLEMENTATION PROCESS

4.1 Quality System Essentials As part of the elaboration of the strategic plan e.g. for the Microbiology laboratory service, testing areas to be established within the service are defined. As the QMS is implemented within the laboratory, all aspects of the QMS (Quality System Essentials) are applied to the different testing areas as illustrated in Figure 2. QMS implementation across all areas is key to ensuring that reliable Microbiology services are provided to support patient care and disease surveillance and control.




8

Fig 2: QMS for Microbiology Laboratories using Quality System Essentials 4.2 Quality Processes The quality management system for medical laboratories can also be defined on the basis of the processes involved. One example of a process-based view of the laboratory quality management system is presented in Figure 3:

A. Organization and quality management system B. Personnel C. Premises and environment D. Equipment, information system and materials E. Pre-examination process F. Examination process G. Post-examination process H. Evaluation and continual improvement




9

Fig 3: Process based quality management systems for medical laboratories (ref. CLAS Guidance Document) 4.3 Gap Assessments and QI Plans Initiation of QMS implementation within the laboratory requires an initial gap assessment to determine the existing extent of implementation of the Standard. Based on this initial gap assessment, a Quality Improvement plan is developed to guide QMS implementation. As a first step, the laboratory staff must undertake an exercise to define all the laboratory processes and the policies that govern them. 4.4 QMS Documentation Establishment and documentation of policies and processes forms the basis for the QMS implementation. Figure 4 illustrates the hierarchy of documentation required for QMS implementation based on relevant agreed Standards. As illustrated in the diagram, document development is a continuous process e.g. as new policies and procedures are introduced based on new requirements of the Standard, introduction of new processes, tests, etc.:

• Agreement on Standards which establish requirements, to




10

• Policies which are statements of intent established to meet requirements of the Standard, to

• Processes which describe what happens in practice, to

• Procedures which describe how processes are carried out, to

• Development of records to provide evidence that procedures have been carried out.

Plans for establishing and implementing a QMS for the laboratory should be included in the Strategic and Action Plans for the laboratory service. Fig. 4: QMS documentation and implementation is based on strategic goals and objectives 5.0 MODELS FOR PHASING OF QMS IMPLEMENTATION Several models have been developed internationally to support phased implementation of QMS, with awards that encourage laboratories to reach international accreditation. Three of these models are described below.




11

1.1 Thailand Model Within developing countries, Thailand has successfully utilized a phased approach to quality systems building. The Thailand model utilizes a national standard which is harmonized with the international Standard ISO 15189 against which assessments are conducted by trained assessors. Laboratories are assigned scores based on their implementation progress and are categorized and recognized by the National Accreditation Scheme as having reached Level 1, Level 2 or Level 3. Laboratories reaching Level 3 can apply for international accreditation. This programme, which is a voluntary programme, has encouraged and resulted in 40% of public laboratories achieving national accreditation in Thailand to date, since the programme was introduced in 2004. An important aspect of this programme is that it is a government initiative which includes a moderate level of financial support to participating laboratories.

1.2 CDC-WHO AFRO Stepwise Accreditation Process

The CDC-WHO AFRO Stepwise Laboratory Accreditation process which was introduced in Africa in 2009, is based on the successful Thailand model with respect to its use of a scoring system based on assessments, with assignment of levels as laboratories progress. The WHO process is intended to assist laboratories to reach accreditation through rewarding them for progress in implementing their QMS. The model awards laboratories achieving the required point levels one, two, three, four or five stars. Laboratories that have achieved five stars are considered to be ready for international accreditation.

1.3 Canadian Model Accreditation Canada has established an international programme for medical laboratory accreditation that is based on a scaling system. The Qmemtum International Accreditation Program as it is called, has three levels (Gold, Platinum, Diamond) of accreditation: Gold – addresses basic structures and processes linked to the foundational elements of safety and quality improvement. Platinum – builds on the elements of quality and safety, and emphasizes key elements of client-centred care, creating consistency in the delivery of services through standardized processes, and involving clients and staff in decision-making. Diamond – focuses on the achievement of quality by monitoring outcomes, using evidence and best practice to improve services, and benchmarking with peer organizations to drive system-level improvements. The Canadian model therefore requires laboratories to implement their QMS in a prescribed incremental manner, while the Thailand and WHO models award points according to the laboratories’ implementation progress and allow laboratories to implement their QMS in any order.




12

6.0 SUGGESTED PHASES AND REQUIREMENTS OF THE STANDARD The natural hierarchy of QMS building has been utilized to develop the phases for QMS implementation within laboratories as outlined in Appendix 1 to this document. The rationale behind the suggested phases is based on the way in which documentation and implementation should progress i.e. documentation of policies then processes to procedures then records, with the final phase in the implementation process being the integration of the QMS into the daily life of the laboratory service as the framework for laboratory operations. In reality, from observations in the field, this natural progression is often interrupted by lack of resources, limitations of staffing, and lack of support from the wider organization. Figure 5 illustrates the basic progression that was utilized to develop the phases described in the table in Appendix 1. Fig 5: Phasing of QMS Implementation leading to accreditation In the interest of providing a model that is scalable and feasible, the following criteria were also utilized to develop the phasing of the proposed model:

• Pre-requisites for quality systems building were included within Phase 1.

• Critical policy and procedure documentation was included in Phases 1 and 2.

• Importance of the element to reliability of testing was also considered in determining the phases.

• Recognition was given to the level of complexity and difficulty in implementation of the element.




13

The table in Appendix 1 is organized according to the elements of the ISO 15189 Standard and the phasing is based on the criteria outlined above. Essential supporting processes for ensuring sustainability are included at the top of the table. 7.0 IMPLEMENTATION STRATEGY The process which should be implemented to ensure QMS implementation in a sustainable manner within developing country environments should include tools and mechanisms for evaluation of phases (defined in Appendix 1 of this document) and an award process to reward and encourage progress. The following process is recommended:

1. Development of a national (or individual) laboratory strategic plan for medical laboratory services (this will require an overall assessment of the current situation with respect to medical laboratory services).

2. Signature of an administrative MOU for phased implementation of medical laboratory services including QMS, between supporting expert agency and the MOH. The expert agency will provide consultants for guiding the process.

3. Conduct of gap analysis by consultants to determine extent of current QMS implementation and to assign a baseline for the intervention.

4. Development of a Quality Improvement Plan (CQI plan) – Phase 1 with indicators, means of verification, timelines and roles and responsibilities.

5. At the end of Phase 1, conduct of an evaluation by consultants. 6. Based on this assessment the level of implementation of laboratory quality

systems will be estimated. Laboratory services achieving their Phase 1 plan will be given recognition by the expert agency or other agreed mechanism for having achieved Phase 1, and a plan for implementation of Phase 2 will be developed.

7. A remedial plan with timelines will be developed for laboratories not achieving their Phase 1 plan to address non-conformities.

Through the above process, laboratories will be supported and encouraged through recognition to move progressively from Phase 1 to Phase 3 of QMS implementation and thus ready themselves for accreditation. .




14

8.0 REFERENCES

1. Caribbean Laboratory Accreditation Scheme (CLAS) Guidance Document for Implementation of ISO 15189. Strengthening of Medical Laboratory Services in the Caribbean (SMLS)

2. Burnett, David - A Practical Guide to Laboratory Accreditation. ACB Venture Publications 2002.

3. A Simple Guide for Implementation of Quality Management Systems in Medical Laboratories. Strengthening of Medical Laboratory Services in the Caribbean.

4. Establishment of Quality Systems and Accreditation in Health Laboratories. Report of Intercountry Workshop. Thailand, October, 2006. World Health Organisation (WHO) South-East Asia.

5. Kusum, Mayura and Silva, Panadda. Quality Standards in Health Laboratories – Implementation in Thailand: A Novel Approach. November 2005. World Health Organisation (WHO) South-East Asia.

6. Qmentum International Program. Accreditation Canada. Self Assessment Checklists for Laboratory Accreditation

7. Qmentum International Program Standards 2010. Accreditation Canada. 8. The ISO 15189:2003 Essentials – A practical handbook for implementing

the ISO 15189:2003 Standard for medical laboratories. Canadian Standards Association.

9. World Health Organisation (WHO) Regional Office for Africa – Laboratory Accreditation Checklist for Clinical and Public Health Laboratories. 2009

10. CLSI Quality System Essentials 11. CLSI ISO 15189:2003 Assessment Checklist 12. ASM Microbiology Laboratory Strengthening Checklist for Zonal/Provincial

Laboratories 13. SLMS Baseline Laboratory Assessment Tool. 2006. 14. Establishing a Microbiology Laboratory – A Simple Guideline for Medical

and Related Public Health Laboratories. SMLS. 2007. (Unpublished)


Appendix 1

Phases for Medical Laboratory Quality M

anagement System Implementation

ISO Requirements

PHASE 1

PHASE 2

PHASE 3

Rationale

SUPPORTING PROCESSES

Supporting processes

– requires wider

organizational

management input and

support

•

National la

bora

tory

netw

ork

or in

div

idual

labora

tory

strate

gic

pla

n

•

Gap A

naly

sis

–

assessm

ent

conducte

d b

y

exte

rnal consultants

•

QI Pla

n d

evelo

ped –

w

ith indic

ato

rs,

responsib

ilities a

nd

tim

elin

es

•

Budget id

entified a

nd

assig

ned for Phase 1

activitie

s

•

End o

f Phase 1

exte

rnal evalu

ation

com

ple

ted

•

% P

hase 1

Qualit

y

Pla

n (C

QI pla

n)

indic

ato

rs s

atisfied

•

CQ

I pla

n

develo

ped

•

Budget id

entified

and a

ssig

ned for

Phase 2

activitie

s

•

End o

f Phase -2

exte

rnal evalu

ation

com

ple

ted.

•

% P

hase 2

Qualit

y

Pla

n (C

QI pla

n)

indic

ato

rs s

atisfied

•

CQ

I pla

n d

evelo

ped

•

Budget id

entified

and a

ssig

ned for

Phase 3

activitie

s

Provides basis for reward

system for achievements

in QMS implementation.

Needs and gaps

identified and remedial

plans developed and

implemented as phases

progress.

MANAGEMENT REQUIREMENTS

4.1

Org

aniz

ation a

nd

managem

ent

•

Org

anogra

m

develo

ped a

nd

sig

ned o

ff

•

Labora

tory

or pare

nt

org

aniz

ation is a

le

gal entity

•

Job d

escriptions for

all

sta

ff c

om

ple

ted

and s

igned o

ff

•

Technic

al

managem

ent by

pers

on a

ppro

priate

ly

Signals Management

Commitment



Resource-Limited Environments

V. Wilson & W. Kitson-Piggott, July 2010

16

ISO Requirements

PHASE 1

PHASE 2

PHASE 3

Rationale

educate

d a

nd tra

ined

•

Sta

ff tra

ined to c

arr

y

out th

eir respective

role

s

•

Suffic

ient sta

ff a

nd

equip

ment and

supplie

s to p

erform

exam

inations

required

4.2

Qualit

y m

anagem

ent

syste

m

•

Qualit

y C

oord

inato

r appoin

ted o

r desig

nate

d

•

Qualit

y P

olic

y

Sta

tem

ent appro

ved

and s

igned o

ff

•

Qualit

y P

olic

y

Manual com

ple

ted

and s

igned o

ff

(inclu

des role

s a

nd

responsib

ilities)

•

Sta

ff instructe

d in

use o

f qualit

y m

anual

•

Qualit

y M

anual

revie

wed a

nd

revis

ed a

t le

ast

annually

•

Evid

ence that

qualit

y o

bje

ctives

have b

een revis

ed

based o

n a

nnual

managem

ent

revie

w o

f Q

MS

•

Evid

ence that sta

ff

have b

een

instructe

d in

qualit

y p

olic

ies a

nd

obje

ctives

•

Evid

ence o

f im

ple

menta

tion o

f Q

ualit

y P

olic

ies –

re

levant

pro

cedure

s a

nd

record

s in p

lace

Signals Management

commitment

4.3

Docum

ent control

•

Docum

ent control

syste

m e

sta

blis

hed

and d

ocum

ente

d in

qualit

y m

anual

•

All

docum

ents

•

Docum

ent control

syste

m inclu

din

g

record

s &

arc

hiv

ing, fu

lly

imple

mente

d

Ensures tracking and

appropriate labelling and

structure of documents

as developed





17

ISO Requirements

PHASE 1

PHASE 2

PHASE 3

Rationale

identified a

nd

appro

ved a

s

described w

ithin

docum

ent control

syste

m

4.4

Revie

w o

f re

quests

and c

ontracts

•

Polic

ies a

nd

pro

cedure

s for

revie

w o

f contracts

esta

blis

hed

•

Evid

ence –

contracts

and

record

s o

f re

vie

ws

•

Evid

ence - record

s

of clie

nt notifications

and a

mendm

ents

if

contracts

am

ended

4.5

Exam

ination b

y

refe

rral la

bora

tories

•

Pro

cedure

docum

ente

d for

evalu

ation a

nd

sele

ction o

f re

ferr

al

labora

tories a

nd

consultants

•

Regis

ter of re

ferr

al

labora

tories a

nd

specim

ens refe

rred

main

tain

ed

•

Evid

ence o

f periodic

revie

w o

f

refe

rral

labora

tories

4.6

Exte

rnal serv

ices

and s

upplie

s

•

Invento

ry c

ontrol

syste

m e

sta

blis

hed

and p

rocedure

docum

ente

d

•

Polic

ies a

nd

pro

cedure

s

esta

blis

hed for

sele

ction a

nd u

se

of key e

xte

rnal

serv

ices,

equip

ment and

supplie

s

•

Pro

cedure

s for

accepta

nce o

f consum

able

s a

nd

verification o

f equip

ment

•

Evid

ence o

f pro

cedure

s follo

wed





18

ISO Requirements

PHASE 1

PHASE 2

PHASE 3

Rationale

esta

blis

hed

4.7

Advis

ory

serv

ices

•

Appro

priate

la

bora

tory

pro

fessio

nal sta

ff in

pla

ce to p

rovid

e

advic

e o

n c

hoic

e o

f exam

inations, use o

f serv

ices a

nd

inte

rpre

tation o

f re

sults

•

Evid

ence o

f m

eetings o

f lab

pro

fessio

nal sta

ff

with c

linic

al sta

ff

Appropriately trained and

competent technical

leadership is key to

ensuring appropriate

selection, usage and

interpretation of results.

4.8

Resolu

tion o

f com

pla

ints

•

Polic

y a

nd

pro

cedure

for

com

pla

ints

or oth

er

feedback

esta

blis

hed

•

Record

s o

f custo

mer com

pla

ints

and resolu

tions

availa

ble

•

Clie

nt & s

takehold

er

com

munic

ation a

nd

feedback

mechanis

m

imple

mente

d

(satisfa

ction s

urv

eys

etc

.)

4.9

Identification a

nd

control of

nonconfo

rmitie

s

•

Polic

y a

nd

pro

cedure

esta

blis

hed for

control of non-

confo

rmitie

s

inclu

din

g root

cause a

naly

sis

•

Evid

ence o

f im

ple

menta

tion o

f pro

cedure

for

control and root

cause a

naly

sis

of

non-c

onfo

rmitie

s

4.1

0 C

orr

ective a

ction

•

Corr

ective a

ction

polic

y a

nd

pro

cedure

docum

ente

d –

to

inclu

de

investigative

pro

cess to

•

Corr

ective a

ction

record

s a

vaila

ble

in

clu

din

g e

vid

ence

of m

onitoring b

y

superv

isor or

manager and revie

w

at m

anagem

ent





19

ISO Requirements

PHASE 1

PHASE 2

PHASE 3

Rationale

dete

rmin

e

underlyin

g

cause(s

) and

monitoring to

dete

rmin

e

effectiveness

revie

w m

eetings

4.1

1 P

reventive a

ction

•

Pro

cedure

s for

pre

ventive a

ction

esta

blis

hed

•

Docum

ente

d

evid

ence that

opportunitie

s for

impro

vem

ent have

been a

cte

d u

pon

and m

onitore

d for

effectiveness

4.1

2 C

ontinual

impro

vem

ent

•

Pro

cedure

for

revie

w o

f opera

tional

pro

cedure

s b

y lab

managem

ent at

regula

r in

terv

als

esta

blis

hed

•

Action p

lans

resultin

g fro

m

revie

ws

docum

ente

d,

imple

mente

d a

nd

changes to Q

MS

made

•

Qualit

y indic

ato

rs

esta

blis

hed a

nd

monitore

d b

y lab

managem

ent to

m

onitor and

evalu

ate

lab’s

contrib

ution to

patient care

4.1

3 Q

ualit

y a

nd

technic

al re

cord

s

•

Pro

cedure

for

identification,

indexin

g,

accessin

g, sto

rage

and d

isposal of

qualit

y record

s

esta

blis

hed

•

Evid

ence o

f re

cord

s

sto

red a

nd

main

tain

ed

accord

ing to

esta

blis

hed

pro

cedure





20

ISO Requirements

PHASE 1

PHASE 2

PHASE 3

Rationale

4.1

4 Inte

rnal audits

•

Polic

y a

nd p

rocedure

esta

blis

hed for

conduct of in

tern

al

audits a

t pre

scribed

inte

rvals

(at le

ast

annually

)

•

Qualit

y M

anager and

senio

r la

b s

taff

train

ed to c

onduct

inte

rnal audits

•

Sta

rt o

f Phase 1

self-

assessm

ent (a

udit)

com

ple

ted

•

End o

f Phase 1

self-a

ssessm

ent

(audit) com

ple

ted

•

Evid

ence o

f conduct of in

tern

al

audits a

nd

corr

ective a

nd

pre

ventive a

ctions

resultin

g fro

m s

uch

audits

•

Evid

ence that

audits a

re

subm

itte

d for

managem

ent

revie

w

•

End o

f Phase 1

self-

assessm

ent (a

udit)

com

ple

ted

Establishes knowledge

base and understanding

of Standard requirements

by management and

staff. Also an educational

exercise.

4.1

5 M

anagem

ent

revie

w

•

Managem

ent R

evie

w

Team

appoin

ted &

opera

tional

•

Pro

cedure

for

managem

ent re

vie

w

esta

blis

hed to

inclu

de d

evelo

pm

ent

of goals

, obje

ctives

and a

ction p

lans

based o

n revie

ws

•

Evid

ence o

f m

eetings o

f m

anagem

ent

revie

w team

and

action p

lans

develo

ped

•

Evid

ence o

f sta

ff

aw

are

ness o

f outc

om

es o

f m

anagem

ent

revie

w

•

Evid

ence o

f im

ple

menta

tion o

f action p

lans in a

tim

ely

manner

Critical element for

supporting and

monitoring the

implementation of the

QMS.

TECHNICAL REQUIREMENTS

5.1

Pers

onnel

•

Sta

ff s

ensitis

ation –

pre

pare

dness

train

ing –

meetings

com

ple

ted

•

Tra

inin

g p

lan

develo

ped for Phase

1 a

ctivitie

s

•

Pers

onnel polic

ies

•

Tra

inin

g p

lan

develo

ped for

Phase 2

activitie

s

•

Com

pete

ncy

measure

ment

syste

ms

imple

mente

d

•

Tra

inin

g p

lan

develo

ped for Phase

3 a

ctivitie

s

•

Continuin

g

Education

pro

gra

mm

e

desig

ned a

nd

imple

mente

d

Training plan neede to

support Phase 1-3

activities





21

ISO Requirements

PHASE 1

PHASE 2

PHASE 3

Rationale

and job d

escriptions

develo

ped

•

Record

s o

f sta

ff

education a

nd

train

ing m

ain

tain

ed

5.2

Accom

modation a

nd

environm

enta

l conditio

ns

•

Housekeepin

g

polic

y a

nd

pro

cedure

s

esta

blis

hed

•

Sta

ff tra

ined in

good

housekeepin

g

pra

ctices

•

Adequate

space

allo

tted to

accom

modate

la

bora

tory

serv

ices

while

ensuring

sta

ff a

nd p

atient

safe

ty a

nd

separa

tion o

f in

com

patible

activitie

s

•

Safe

ty a

nd w

aste

dis

posal

pro

gra

mm

e

imple

mente

d

•

Com

munic

ation

syste

m a

ppro

priate

to

needs o

f th

e

labora

tory

serv

ice

in p

lace

•

Adequate

te

mpera

ture

controlle

d s

tora

ge

space a

llocate

d to

meet la

bora

tory

needs

5.3

L

abora

tory

equip

ment

•

Equip

ment in

vento

ry

com

ple

ted

•

Equip

ment re

cord

develo

ped for each

pie

ce o

f equip

ment

•

Sta

ff tra

ined in u

se

and m

ain

tenance o

f equip

ment

•

Pre

ventive

main

tenance

pro

gra

mm

e

docum

ente

d a

nd

imple

mente

d

accord

ing to

manufa

ctu

rer

specific

ations

•

Equip

ment re

pair

and d

isposal polic

y

and p

rocedure

s

•

Evid

ence that

equip

ment

main

tenance

pro

gra

mm

e is

opera

tional

(record

s)

•

Evid

ence o

f im

ple

menta

tion o

f equip

ment upgra

de,

calib

ration a

nd

verification





22

ISO Requirements

PHASE 1

PHASE 2

PHASE 3

Rationale

imple

mente

d

•

Polic

y a

nd

pro

cedure

s for

equip

ment

upgra

de,

calib

ration a

nd

verification

esta

blis

hed

•

Sta

ff tra

ined in

equip

ment

main

tenance,

calib

ration a

nd

verification

pro

cedure

s

pro

gra

mm

e

5.4

Pre

-exam

ination

pro

cedure

s

•

Sam

ple

accessio

nin

g

and m

anagem

ent

syste

m (polic

y a

nd

pro

cedure

s) to

ensure

tra

ceabili

ty

and d

ete

rmin

e

sam

ple

accepta

bility

in

pla

ce

•

Request fo

rms

pro

vid

ing a

ll in

form

ation n

eeded

by the labora

tory

develo

ped

•

Labora

tory

sam

ple

colle

ction/u

ser

manual develo

ped

•

Evid

ence (re

cord

s)

of o

pera

tion o

f sam

ple

accessio

nin

g a

nd

managem

ent

syste

m

•

Request fo

rms

pro

vid

ing a

ll in

form

ation

needed b

y the

labora

tory

in u

se

•

Evid

ence o

f dis

trib

ution a

nd

imple

menta

tion o

f sam

ple

colle

ction/u

ser

manual

5.5

Exam

ination

pro

cedure

s

•

Sta

ndard

Opera

ting

Pro

cedure

s (SO

Ps)

for all

tests

com

ple

ted (in

clu

din

g

•

Evid

ence o

f im

ple

menta

tion o

f SO

Ps

•

Polic

y a

nd

•

Test valid

ation

syste

m a

nd

pro

cedure

for

introduction o

f new





23

ISO Requirements

PHASE 1

PHASE 2

PHASE 3

Rationale

job a

ids) and s

igned

off b

y L

abora

tory

D

irecto

r

pro

cedure

for te

st

valid

ation a

nd

introduction o

f new

te

sts

develo

ped

tests

opera

tional

5.6

Assuring the q

ualit

y

of exam

ination

pro

cedure

s

•

Qualit

y c

ontrol

requirem

ents

docum

ente

d w

ithin

SO

Ps for all

tests

•

Qualit

y c

ontrol

mate

rials

availa

ble

and run a

s required

for all

tests

•

Pro

ficie

ncy testing

mate

rial or

inte

rlabora

tory

com

parison a

vaila

ble

fo

r all

test are

as

•

QC

pro

gra

mm

e

docum

ente

d a

nd

imple

mente

d for all

routine tests

•

Pro

ficie

ncy testing

(and

inte

rlabora

tory

te

sting) polic

y a

nd

pro

cedure

docum

ente

d a

nd

imple

mente

d

•

Pro

gra

mm

e for

calib

ration o

f m

easuring

syste

ms a

nd

verification o

f trueness

docum

ente

d

•

Pro

gra

mm

e for

dete

rmin

ation o

f

measure

ment

uncertain

ty o

f m

eth

ods

docum

ente

d

•

Evid

ence o

f re

vie

w

of pro

ficie

ncy testing

and inte

rlabora

tory

te

sting results a

nd

imple

menta

tion o

f corr

ective a

ctions

•

Evid

ence o

f corr

ective a

ctions

taken b

ased o

n o

ut

of control Q

C results

•

Evid

ence o

f im

ple

menta

tion o

f calib

ration

pro

gra

mm

e w

ith

corr

ective a

ctions a

s

necessary

•

Evid

ence o

f im

ple

menta

tion o

f m

easure

ment

uncertain

ty

pro

gra

mm

e

5.7

Post-exam

ination

pro

cess

•

Polic

y a

nd p

rocedure

fo

r re

vie

w a

nd

verification o

f re

sults

by a

uth

orized

pers

onnel befo

re

rele

ase, esta

blis

hed

and d

ocum

ente

d

•

Evid

ence o

f re

vie

w

and v

erification o

f re

sults b

y

auth

orized

pers

onnel befo

re

rele

ase

•

Evid

ence o

f





24

ISO Requirements

PHASE 1

PHASE 2

PHASE 3

Rationale

•

Polic

y for sto

rage o

f prim

ary

sam

ple

s

docum

ente

d

sto

rage o

f prim

ary

sam

ple

s in

accord

ance w

ith

polic

y

5.8

Reportin

g o

f re

sults

•

Reportin

g form

desig

ned to p

rovid

e

all

info

rmation

required b

y u

sers

and to m

eet

requirem

ents

of th

e

Sta

ndard

•

Critical valu

e

reportin

g p

olic

y a

nd

pro

cedure

docum

ente

d

•

Evid

ence o

f use o

f appro

priate

re

portin

g form

•

Evid

ence o

f im

ple

menta

tion o

f critical valu

e

reportin

g

pro

cedure

•

Polic

y a

nd

pro

cedure

for

rete

ntion a

nd

sto

rage o

f re

ports

esta

blis

hed

•

Polic

y a

nd

pro

cedure

for

corr

ecte

d report

esta

blis

hed

•

Data

managem

ent

syste

m e

nsuring

confidentialit

y

(manual or

ele

ctronic

) opera

tional

•

Evid

ence o

f im

ple

menta

tion

sto

rage a

nd

rete

ntion p

olic

y a

nd

pro

cedure

•

Evid

ence o

f im

ple

menta

tion o

f corr

ecte

d report

pro

cedure

ASM – QMS Implementation for Microbiology Laboratories – Document 2 of 3

American Society of Microbiology

QMS Implementation Stepwise Phases Resource-Limited Environments


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Documents

Stepwise Phases For Quality Management Systems … · 2020. 11. 16. · QMS Implementation for Laboratories Training for Sustainable Laboratory Development In Resource-Limited Environments