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ISO 9000:2000

Rumah Sakit

Dr. Dody Firmanda, SpA, MA


Executive Summary :
Patient Safety, Six Sigma & ISO 9000 Quality Management

Today's world health care performing to ensure the delivery of quality

patient care at significantly lower level:
‰ An estimated 120 000 deaths occur every year due to
medical mistakes?1
‰ The IOM reported that medical mistakes in the United
States cause as many as 98,000 hospital deaths per year.2
‰ These stunningly high rates of medical errors--resulting in
deaths, permanent disability and unnecessary suffering--are
simply unacceptable in a medical system that “promises to do
no harm." 3
1. Gerlin, A. How Your Hospital Could Kill You. Reader's Digest, June 2000, p. 174.
2. Tickner, N, O'Neill M. Preventing Death and Injury From Medical Errors Requires Dramatic,
Systemwide Changes. press release, Institute of Medicine, Division of Health Care Services,
November 29, 1999.
3. Ibid.
Inspection Quality Quality Total
Inspection Quality Quality Total
Control Assurance Quality
Control Assurance Quality

a.a.Setting Understanding Understanding Quality Quality

SettingStandards Understanding Understanding Quality CQI Quality
Standards the business the customers System CQI Tools
the business the customers System Tools

c cMaintained
BSI 5751
EN/ISO 9000
Health MBNQA

Evolusi NICE Needs EQA

Assessment Benchmarking Award
Deming Prize Award
Clinical SQL


Readers’ Users’ Guides Evidence-
Clinical Health Care Information
Guides to to Medical based
Epidemiology (EBHC): Mastery
Medical Literatures Medicine
• Policy
Literatures (EBM)
• Health
80an 90an Abad 21
• Others
Understanding the

Need Assessment

Understanding the
customers PIP (Investors in People)
Quality QA Model:
System P ISO 9000
A D TQM Model:

Setting standard Quality Tools Statistical Process Control

Wants Goals

Demands Aims
Needs Objectives Input Process Ouput Outcome Benefit
Adequacy Efficiency Efficacy
Accessability Effectiveness

Impact Maxwell

Targets Input Process Outcome

1. Vision : futuristic mind-setting of the organisation

2. Missions: ways of the organisation towards the vision

3. Goals : are broad statements. There is generally one goal for a
4. Aims : There are a number of aims relating to the goal. They are
specific to particular problems.
5. Objectives : For each programme aim, there may be a number of
objectives which are specified in measurable terms.
6. Targets/Minimal Thresholds : For each objective, there may be
various points on the way to the attainment of the objective.
They are defined in relation to a point in a time.

Systems/Standards Indicators
ISO 9000: 2000
The ISO 9000 Core Standards
There are four Core Documents, as follows:
1. ISO 9000:2000 provides quality management principles and
fundamentals. It describes what the series is about and lists basic
definitions of terms for use by any organization.
2. ISO 9001:2000 states requirements for quality management
systems when it is necessary to demonstrate that an organization
is capable of effectively meeting customer and regulatory
requirements, such as JCAHO, NCQA, URAC or state and
federal requirements.
3. ISO 9004:2000 provides guidance for establishing a quality
management system that goes beyond ISO 9001 requirements to
meet and exceed customer expectations efficiently.
4. ISO 19011 provides guidance on planning and conducting
quality audits.
Model of a process-based quality management system
Clauses in the ISO 9001 Quality Systems Standard

ISO 9001:2000 consists of:

• 5 primary clauses that contain 23 sub-clauses.
• These requirements spell out what organization and possibly
must do to conform to the standard.
• All the requirements must be documented and controlled.

The Clauses are as follows:

4. Quality Management System

5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis and Improvement
Quality Standards (Clauses/Subclauses) Quality Procedures Quality Records

1. General

1.1. Index and revision status

1.2. Purpose and scope
1.3. Exclusions
2. Company background

2.1. Company background and history

2.2. Activities

3. Definitions and convention D 0001 Definitions and terminology

D 0002 Abbreviations
3.1. Definitions and conventions D 0003 Index of the quality manual
3.2. Abbreviations
Clause 4. Quality Management System (QMS)

Quality Quality Procedures Quality Records

4.1. P 421 Quality system documentation D 4301 Procedures
General P 422 Control of documents D 4302 Process plans
requirements P 423 Control of quality records D 4303 Work instructions
D 4304 System documents
4.2. D 4305 Specific documents
Documentation D 4306 External documents
and records D 4307 Paraphs
D 4308 Distribution of the quality manuals
D 4309 Distribution of the process files
D 4310 Distribution of the personal files
D 4311 Table of contents of process files
D 4312 Table of contents of personal files
D 4313 Document change request
Clause 5. Management Responsibility

Quality Standards Quality Quality Records

(sub-clauses) Procedures
5.1. Management commitment P 521 Customer needs and D 5301 Quality policy
5.2. Customer focus communications D 5401 Quality objectives
5.3. Quality policy D 5501 Organization scheme
5.4. Quality system planning D 5502 Overview of the
5.5. Organization and communication P 561 Management review functions
5.6. Management review
Clause 6. Resource Management

Quality Standards Quality Procedures Quality Records

6.1. Provision of resources P 621 Training and awareness D 6201 Personnel card
6.2. Human resources and trainings D 6202 Function descriptions
6.3. Infrastructure D 6203 Training
6.4. Work environment D 6301 Maintenance card
D 6303 Maintenance schedule
D 6304 Maintenance
D 6305 Different tasks
Clause 7. Product Realisation

Quality Standards Quality Procedures Quality Records

7.1. Planning of product realisation P 721 Order processing D 7201 Overview of our own products
7.2. Customer related processes P 731 Design control D 7202 Specifications of our own products
P 741 Supplier evaluation D 7203 Customer complaints
7.3. Design control
P 742 Purchasing D 7204 Customer feedback
7.4. Purchasing D 7301 Overview of product development
P 743 Verification of purchased
7.5. Operations D 7302 Design specification
7.6. Measuring and monitoring P 751 Handling, storage, packaging, D 7303 Design output
equipment D 7304 Design review
preservation and delivery D 7305 Design verification
P 761 Measuring and monitoring D 7306 Design validation
equipment D 7307 Design changes
D 7308 Design actions
D 7401 Overview of the purchased products
D 7402 Specifications of the purchased products
D 7403 Supplier assessment
D 7405 Approved suppliers
D 7406 Suppliers on probation
D 7601 Calibration cards
D 7602 List of measuring devices
D 7603 Calibration schedule
D 7604 Calibration survey
D 7605 Calibration results
Clause 8. Measurement, analysis and improvement
Quality Standards Quality Procedures Quality Records

8.1. Planning of monitoring and P 821 Customer satisfaction D 8201 Internal auditors
measurement P 822 Internal quality audits D 8202 Audit schedule
8.2. Monitoring and measurement P 823 Inspection and test procedure D 8203 Audit report
8.3. Control of non-conforming P 831 Control of non-conforming D 8401 Customer card
product product D 8402 Supplier card
8.4. Analysis of data P 851 Corrective and preventive actions D 8403 Internal problems since
8.5. Continual improveme one year
D 8501 Meeting schedule
D 8502 System meetings
D 8503 Specific meetings
D 8504 Project data
D 8505 Projects
D 8506 Corrective action request
D 8507 Executed actions
D 8508 Present actions
Basic Quality Performance Wheel

Program Performance
Cost Measurement

Partial Wheel with Goals
% F ir e /S m o k e
C o n ta in m e n t
% B a c k I n ju r y D e f ic ie n c ie s % S to r a g e
R e d u c t io n R e d u c t io n D e f ic ie n c ie s
R a te R e d u c tio n
100 O v e r a ll
C u sto m e r 100
5 S e r v ic e
S a tis fa c ti o n
P a r tic ip a t io n

T e le p h o n e 80 N o. of
C ascade 0 F a ls e F ire
N o tif ic a ti o n 80 A la rm s p e r
80 0
C o m p le tio n 100 m o n th

80 3
S a f e ty
S taff
M anagem ent S ta ff
K n o w le d g e
95 K n o w le d g e
L i fe 95
80 E m ergency
S a f e ty 80
P r e p . M g m t.
M g m t.

S e c u r ity
U ti lit y
13 M g m t.
M g m t. 13
H az/
U n s c h e d u le d 0 0 E n v ir o n . In s p e c t.
E q u ip t. M a t.
S h u td o w n s C ite d S m o k in g
M g m t. M g m t.
p e r m o n th V io la tio n s / 6 m o n th s
80 0

0 80
80 25
H o t/C o ld % C r im e
80 80
E n v ir o n . C a lls R a te p e r
p e r m o n th Y ear
R e d u c t io n
P e r s o n a l ly M SDS
O w n ed D e v ic e 95 P ro g ram
D e f ic ie n c ie s
S ta ff
M e d ic a l
K n o w le d g e
E q u ip . I n v e n to r y
D a t a A c c u ra c y
Hospital Based Performance Wheel
Im p le m en t
N ew C lin ic a l
In cr ea se d
P ra c tic e
R evenu e
G u id e lin es

$ 1 5 M il 12
% C o st
% In c r e a se d
R e d u c tio n
P r o d u c tiv ity
$ 1 2 M il 8
10 20

5 10

% D ec re a se
in In v e n to ry
15 10 P ro g ra m % D e c r e a se
C ost 20 35 in W a itin g
T im e
P e rfo rm a n c e
M e a s u re m e n t
Im p ro v e m e n t
40 C u s to m e r 15
S a tis fa c tio n
60 20 % D ec re a se
T im e lin e ss B ed D ays
o f A c c e ss of C are
85 20

95 5 30 30
% S a tisfa c tio n
% D ec re a se
per Survey
A b se n te eism
0 50
D ec re a se
C u sto m er
O p er a tin g B e d s
C o m p la in ts
Statistical Tools

Data/Check Sheets
C Statistical
Histograms Pareto Diagrams
U (Root Cause)
E Run Charts
Control Charts

Analytical Tools

Data/Check Sheets
C Statistical
A Histograms Pareto Diagrams
U (Root Cause)

E Run Charts
Control Charts


Affinity Diagram Brainstorming

S Analytical
Tree Diagrams Matrix Diagrams Fishbone Nominal Group Flow Charts
U Diagrams Techniques
I Force Field
O Analysis
N D.A Simmons PDCA Model
S 5/97
Tools with Problem Solving Techniques
Data/Check Sheets
C Statistical Steps of Problem
A Tools Solving
U Histograms Pareto Diagrams 1. Prioritize Problems
4,5,7,10 (Root Cause)
S 2. Analyze Symptoms
E 3. Formulate Theories
4. Test Theories
S Run Charts 5. Identify Causes
4,5,7,11 6. Evaluate Solutions
7. Design Solutions
Control Charts 8. Address Resistance
4,5,7,11 9. Implement Solutions
10. Check Performance
Process 11. Monitor Controls

S Analytical Affinity Diagram Brainstorming

O Tools 3
Tree Diagrams Matrix Diagrams Fishbone Nominal Group Flow Charts
I 12 Diagrams Techniques
7 2,4,5,6,7,9
O 3
S Force Field
D.A Simmons
PDCA Model
Model: Integrated Health Care Quality Management

Integrated Health Care

Quality Management

Process Quality Management Outcome Quality Management

Process Management Hospital Manual OQM System Benchmarking

(Optimization) (Documentation) (Documentation) (Evaluation)
Project Work ISO System Medical Outcomes Quality (Output)
Quality Circles Processes/Standard Operating Procedures Financial Results Costs (Input)

Pathway Management Outcome Management

Controlling of Processes and Standards Controlling of
(Financial and Medical) Results
Terima Kasih