IWA 1:2005
(Main)Quality management systems - Guidelines for process improvements in health service organizations
Quality management systems - Guidelines for process improvements in health service organizations
IWA 1:2005 provides additional guidance for any health service organization involved in the management, delivery, or administration of health service products or services, including training and/or research, in the life continuum process for human beings, regardless of type, size and the product or service provided.
Systèmes de management de la qualité — Lignes directrices pour l'amélioration des procédés dans les organisations des services de santé
Sistemi vodenja kakovosti – Smernice za izboljšave procesov v zdravstvenih organizacijah
General Information
- Status
- Withdrawn
- Publication Date
- 02-Oct-2005
- Withdrawal Date
- 02-Oct-2005
- Technical Committee
- ISO/TMBG - Technical Management Board - groups
- Drafting Committee
- ISO/TMBG - Technical Management Board - groups
- Current Stage
- 9599 - Withdrawal of International Standard
- Start Date
- 27-Jan-2014
- Completion Date
- 13-Dec-2025
Relations
- Effective Date
- 15-Apr-2008
Frequently Asked Questions
IWA 1:2005 is a standard published by the International Organization for Standardization (ISO). Its full title is "Quality management systems - Guidelines for process improvements in health service organizations". This standard covers: IWA 1:2005 provides additional guidance for any health service organization involved in the management, delivery, or administration of health service products or services, including training and/or research, in the life continuum process for human beings, regardless of type, size and the product or service provided.
IWA 1:2005 provides additional guidance for any health service organization involved in the management, delivery, or administration of health service products or services, including training and/or research, in the life continuum process for human beings, regardless of type, size and the product or service provided.
IWA 1:2005 is classified under the following ICS (International Classification for Standards) categories: 03.120.10 - Quality management and quality assurance; 11.020 - Medical sciences and health care facilities in general. The ICS classification helps identify the subject area and facilitates finding related standards.
IWA 1:2005 has the following relationships with other standards: It is inter standard links to IWA 1:2001. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase IWA 1:2005 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.
Standards Content (Sample)
International Workshop
Agreement
IWA 1
Quality management systems —
Guidelines for process improvements
in health service organizations
* * * *
Based on ISO 9004:2000,
Second edition, 2005-04-01
Quality management systems —
Guidelines for performance improvements
©
Reference number ISO 2005
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© ISO 2005
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ii © ISO 2005 – All rights reserved
Quality Management Systems — Guidelines for IWA 1:2005(E)
process improvements in health service organizations
Contents Page
Foreword . vi
Foreword - Supplemental . viii
Introduction . x
0.1 General . x
0.2 Process approach . x
0.2.1 Primary health service process . xii
0.3 Relationship with ISO 9001 . xiii
0.4 Introduction . xiii
1 Scope . 1
1.1 Scope – Health services additions . 1
2 Normative reference . 2
3 Terms and definitions . 2
3.1 Terms and definitions - Supplemental . 2
4 Quality management system . 7
4.1 Managing systems and processes . 8
4.2 Documentation . 9
4.2.1 Control of documents - Supplemental . 10
4.2.4 Control of records - Supplemental . 12
4.3 Use of quality management principles . 13
5 Management responsibility . 14
5.1 General guidance . 14
5.1.1 Introduction .14
5.1.2 Issues to be considered . 15
5.2 Needs and expectations of interested parties .16
5.2.1 General . 16
5.2.2 Needs and expectations . 17
5.2.2.1 Product safety . 18
5.2.2.2 Product efficacy . 18
5.2.2.3 Security . 18
5.2.2.4 Community service . 19
5.2.2.5 Social responsibility . 19
5.2.3 Statutory and regulatory requirements . 19
5.2.4 Patient/client care practices . 19
5.3 Quality policy . 20
5.4 Planning . 21
5.4.1 Quality objectives . . 21
5.4.2 Quality planning . 22
5.4.3 Business planning . . 23
5.4.4 Error proofing . 23
5.5 Responsibility, authority and communication . 25
5.5.1 Responsibility and authority . 25
5.5.1.1 Responsibility and authority - Supplemental . 25
5.5.2 Management representative . 26
5.5.3 Internal communication . 26
5.6 Management review . 27
5.6.1 General . 27
5.6.2 Review input . 28
5.6.3 Review output . 29
6 Resource management . 30
process improvements in health service organizations
6.1 General guidance. . 30
6.1.1 Introduction . . 30
6.1.2 Issues to be considered . . 30
6.1.2.1 Shift resources . . 30
6.2 People …………. . . 31
6.2.1 Involvement of people . . 31
6.2.2 Competence, awareness and training . . 32
6.2.2.1 Competence . . 32
6.2.2.1.1 Credentials and health status . . . 32
6.2.2.1.2 Quality management and requalification . . 32
6.2.2.1.3 Communication skills . . 33
6.2.2.2 Awareness and training . . 33
6.2.2.2.1 Ongoing training . . 34
6.2.2.2.2 Identification of patient/client’s family education/training programs . . 34
6.3 Infrastructure . 35
6.3.1 Hazardous waste handling . 35
6.4 Work environment . . 36
6.5 Information . . 36
6.6 Suppliers and partnerships . .37
6.6.1 Supply-purchased product . .37
6.7 Natural resources . . 37
6.8 Financial resources . . 37
7 Product realization . . . 39
7.1 General guidance . . 39
7.1.1 Introduction . . . 39
7.1.2 Issues to be considered . . 40
7.1.3 Managing processes . . 40
7.1.3.1 General . . . 40
7.1.3.2 Process inputs, outputs and review . . 41
7.1.3.2.1 Planning of realization processes . . . 41
7.1.3.3 Product and process validation and changes . . 42
7.2 Processes related to interested parties . 44
7.2.1 Contract review . . . 45
7.3 Design and development . . 46
7.3.1 General guidance . . 46
7.3.1.1 Design process . . . 46
7.3.2 Design and development input and output . . 47
7.3.2.1 Facility and equipment planning . . . 48
7.3.3 Design and development review . . 49
7.3.3.1 Selecting care approaches . . . 50
7.4 Purchasing . . 52
7.4.1 Purchasing process . . 52
7.4.1.1 Purchasing control . . 53
7.4.1.2 Urgently needed purchased product . . 53
7.4.2 Supplier control process . . 53
7.4.2.1 Predetermined suppliers . . 53
7.4.2.2 Subcontracted services . . 54
7.5 Production and service operations . 56
7.5.1 Operation and realization . 56
7.5.1.1 Manage patient/client care processes . . . 56
7.5.1.2 Servicing . . 56
7.5.2 Identification and traceability . 58
7.5.4 Customer property . 58
7.5.5 Preservation of product . 59
7.5.5.1 Preservation of product - Supplemental . . 60
7.6 Control of measuring and monitoring devices . 61
7.6.1 Control of measuring and monitoring devices - Supplemental . 61
8 Measurement, analysis and improvement . 62
iv © ISO 2005 – All rights reserved
Quality Management Systems — Guidelines for IWA 1:2005(E)
process improvements in health service organizations
8.1 General guidance . 62
8.1.1 Introduction . 62
8.1.1.1 Planning measurement . 63
8.1.2 Issues to be considered . 63
8.2 Measurement and monitoring . 64
8.2.1 Measuring and monitoring of system performance . 64
8.2.1.1 General . 64
8.2.1.2 Measurement and monitoring of customer satisfaction .64
8.2.1.2.1 Measurement and monitoring of customer satisfaction - Supplemental .65
8.2.1.3 Internal audit . 66
8.2.1.3.1 Strategic auditing . 67
8.2.1.4 Financial measures . 67
8.2.1.5 Self-assessment . 67
8.2.2 Measuring and monitoring of processes . 68
8.2.2.1 Measuring and monitoring of processes - Supplemental . 68
8.2.3 Measuring and monitoring of product . 69
8.2.3.1 Measuring and monitoring of product - Supplemental . 70
8.2.4 Measurement and monitoring the satisfaction of interested parties . 70
8.3 Control of nonconformity . 72
8.3.1 General . 72
8.3.1.1 Handling of nonconforming product . 72
8.3.2 Nonconformity review and disposition . 72
8.4 Analysis of data . 73
8.5 Improvement . 75
8.5.1 General . 75
8.5.1.1 General - Supplemental . 75
8.5.2 Corrective action . 76
8.5.2.1 Corrective action process . 77
8.5.3 Loss prevention . 77
8.5.4 Continual improvement of the organization . 78
Annex A (informative) Guidelines for self-assessment . 80
Annex B (informative) Process for continual improvement. 82
Bibliography . 84
process improvements in health service organizations
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). ISO's technical work is normally carried out through ISO technical committees in which
each ISO member body has the right to be represented. International organizations, governmental and non-
governmental, in liaison with ISO, also take part in the work.
In order to respond to urgent market requirements, ISO has also introduced the possibility of preparing
documents through a workshop mechanism, external to its normal committee processes. These documents
are published by ISO as International Workshop Agreements. Proposals to hold such workshops may come
from any source and are subject to approval by the ISO Technical Management Board which also designates
an ISO member body to assist the proposer in the organization of the workshop. International Workshop
Agreements are approved by consensus amongst the individual participants in such workshops. Although it is
permissible that competing International Workshop Agreements exist on the same subject, an International
Workshop Agreement shall not conflict with an exisiting ISO or IEC standard.
An International Workshop Agreement is reviewed after three years, under the responsibility of the member
body designated by the Technical Management Board, in order to decide whether it will be confirmed for a
further three years, transferred to an ISO technical body for revision, or withdrawn. If the International
Workshop Agreement is confirmed, it is reviewed again after a further three years, at which time it must be
either revised by the relevant ISO technical body or withdrawn.
Attention is drawn to the possibility that some of the elements of this International Workshop Agreement may
be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Workshop Agreement IWA 1 was approved at a workshop organized jointly by the Automotive
Industry Action Group (AIAG), the American Society for Quality (ASQ) (Healthcare Division), the Standards
Council of Canada (SCC) and CSA International, and held in January 2001. Appreciation is extended to the
Automotive Industry Action Group (AIAG), the American Society for Quality (ASQ) (Healthcare Division), the
Standards Council of Canada (SCC) and CSA International for both the organization of the workshop and the
preparation of this International Workshop Agreement.
This second edition of IWA 1 cancels and replaces the first edition (IWA 1:2001). It provides the content of the
first edition but with improved appearance.
vi © ISO 2005 – All rights reserved
Quality Management Systems — Guidelines for IWA 1:2005(E)
process improvements in health service organizations
nd
Foreword to IWA 1, 2 Edition – Supplemental
nd
The IWA 1 2 Edition is intended to provide the IWA 1,1st Edition content with the same intent, but
with improved appearance and usefulness. This is not the only way to interpret the ISO 9000 series
of standards for health service organizations. The examples, definitions, and text given are only
representative of how the wording is used within the context of this document. Organization-specific
terminology can be used as applicable. These changes were the compilation of developments or
comments received since the original workshop from IWA 1, from reviewers who were primarily
providers, and some of the comments from the original workshop not previously incorporated.
Layout of this Edition:
Text in the solid box is from ISO 9001:2000. Black text outside the box is from ISO 9004:2000, which is both
generic guidance and applicable to all organizations. Italicized text in Times New Roman font is material
added by AIAG, ASQ or the IWA-1 Workshop aimed at assisting health service organizations
specifically.
Also new in this Edition is guidance on “What to look for” as well as examples when implementing
IWA 1 guidance.
Implementing this guidance and maintaining the system with discipline and rigor throughout the
organization should produce effectiveness and efficiencies with a cost benefit up to 17:1 based on
experience of other sectors. This document can be used to implement a quality system that is
compliant with and can be third party certified to ISO 9001 if the organization desires.
Acknowledgements are due to the following for their contribution to this Edition:
o Marvin “Mickey” Christensen, TQM Systems (ASQ-Healthcare Division Standards
committee)
o R. Dan Reid, General Motors Powertrain
o Reginald Shaughnessy, Q-Norm
o Ulises Ruiz Ferandiz MD, Universidad Comlutensa, Madrid
o Peggy Congin, RN, Cleveland Clinic
o Jane DeHart, OTR, Midwest Health System, Work-Safe Occupational Health
o Ema Demink, AIAG
o Ron Tillinger, AIAG
o Joe McMahon, Standards Council of Canada
o David Zimmerman, Canadian Standards Association
o Jim Collins, Plexus Training
o Rita Radcliff, MD, Medical Excellence
February 2005
© Copyright 2000, 2004, 2005 ISO, AIAG vii
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Foreword-Supplemental
This guideline is the product of a committee under the American Society for Quality (ASQ) Health
Care Division and the Automotive Industry Action Group (AIAG), consisting of the following
members:
Robert Abbott, President, Unicorn Grove Enterprises, Inc., Registered QMS Lead Auditor, Audits
for RAB
M.M. “Mickey” Christensen, P.E., President, TQM Systems, Registered Professional Engineer,
Registered QMS Lead Auditor, Chair, ASQ Health Care Division Standards Committee
Margaret Class, RN, Commander, U.S. Navy, Loaned Executive to Joint Commission on
Accreditation of Health Care Organizations, Bethesda Naval Hospital
Jane DeHart, MA, OTR, Administrative Director of Occupational Health, Henry Ford Health
System
Thomas L. Gavan, M.D., Resident Emeritus staff, Division of Pathology and Laboratory
Medicine, The Cleveland Clinic Foundation. Initial drafter of ISO 15189 "Quality management
in the Medical Laboratory". Member US TAG ISO/TC212 and Member ISO/TC212 WG1
Jim Hindelang, ASQ CQA, Consultant, Results Systems, Inc., Registered QMS Auditor
Herbert Monnich, Jr., P.E., ASQ CQA, CQE, CRE, Consultant, Member of US TAG to TC 176,
Assembled US TAG comments together for TC 179 Product Introduction & Transition package
and ISO/TC 176 N488 Communiqué on the Results of the IAF-ISO/TC 176 - ISO/CASCO joint
session on Transition Planning for Year 2000 ISO 9000 Standards
Laura DeVincentis Prioli, MPA, Health Care Services Manager, SGS International Certification
Services, Inc., Registered QMS Lead Auditor
R. Dan Reid, M.B.S., M.A., ASQ CQE, Manager, General Motors Worldwide Purchasing, AIAG
Health Care Project Team, International Automotive Task Force (IATF) Delegation Leader
(Past) & ISO 9000:2000 Drafting Committee (T.G 1.7.7)
Thomas Reiley, MD, MHS, President, Synapse Consultation, PC, Chair (Past), ASQ Health Care
Division
David Simmons, P.E., PhD, President, Health service Engineering, Registered Professional
Engineer, Past Chair, ASQ Health Care Division
Prof. Ulises Ruiz, MD, PhD, FACS, University Institute for Health Care Assessment,
Universidad Complutense de Madrid, 28040 MADRID, Spain
Acknowledgements are due to the following that participated in preparation of this document:
Bruce Bradley, General Motors;
Adam Miller, UAW;
Carol Sauwen, General Motors;
Don Longnecker, DaimlerChrysler;
viii © Copyright 2000, 2004, 2005 ISO, AIAG
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Renee Turner-Bailey, Ford Motor Company;
Beth Ginzinger, Ford Motor Company;
Matti Liukko, M.D. M.Q., Medical Administrator, Finnish Association of Local and Regional
Authorities;
Viljo Rissanen, MD, Deputy Medical Director, Kuopio University Hospital, Kuopio, Finland;
Melvin Alexander, CQE, MS, ASQ Fellow, GloboMax LLC;
Ronald G. Berglund, MPH, CHE, CQmgr., Management Resources International of MSX,
International;
Jim Collins, MS, Master Trainer, Plexus Corporation;
Paul Schyve, MD, Joint Commission for Accreditation of Healthcare Organizations;
Maureen Carr, Joint Commission for Accreditation of Healthcare Organizations;
Gary Carneal, American Accreditation Health Care Commission (URAC);
Guy D’Andrea, American Accreditation Health Care Commission (URAC);
Suzanne Atkinson, representative of the National Committee for Quality Assurance (NCQA).
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process improvements in health service organizations
INTRODUCTION
The goal of this document is to aid in the development or improvement of a fundamental quality
management system for health service organizations (see 3.1.8) that provides for continuous
improvement, emphasizing error or adverse outcomes prevention, the reduction of variation and
organizational waste, for example non-value added activities (3.1.25).
This guide incorporates much of the text of ISO 9004:2000 – “Quality management systems --
Guidelines for performance improvements” and provides guidance on quality management systems,
including the processes for continual improvement that contribute to the satisfaction of a health
service organization’s customers (see 3.1.3) and other interested parties. The quality management
system should provide for all customers of a health service organization regardless of the product,
profession or service provided.
0.1 General
See ISO 9004:2000.
0.2 Process approach
This International Standard promotes the adoption of a process approach when developing, implementing and
improving the effectiveness and efficiency of a quality management system to enhance interested party
satisfaction by meeting interested party requirements.
For an organization to function effectively and efficiently, it has to identify and manage numerous linked
activities. An activity using resources, and managed in order to enable the transformation of inputs into
outputs, is considered as a process. Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification and
interactions and managing of these processes can be referred to as the “process approach”.
An advantage of the process approach is the ongoing control that it provides over the linkage between the
individual processes within the system of processes, as well as their combination and interaction.
Health service organizations should define all their processes. These processes, which are typically
multi-disciplinary, include administrative and other support services as well as those involving
treatment, include such examples as the:
a) development and delivery of training as required by competencies or credentialing
b) surgery processes and the necessary ancillary support services
c) preventive and predictive maintenance program
d) design and/or development of diagnostic protocols/ pathways.
e) Billing and coding for services correctly
f) Continuum of care for patient, regardless of setting or location
When used within a quality management system, such an approach emphasizes the importance of
a) understanding and fulfilling the requirements,
b) the need to consider processes in terms of added value,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.
The model of a process-based quality management system shown in Figure 1 illustrates the process linkages
presented in clauses 4 to 8. This illustration shows that interested parties play a significant role in defining
requirements as inputs. Monitoring the satisfaction of interested parties requires the evaluation of information
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process improvements in health service organizations
relating to the perception of interested parties as to whether the organization has met their requirements. The
model shown in Figure 1 does not show processes at a detailed level.
All work should be viewed as a process, and part of a system (see ISO 9000:2000, clause 2.2.1). To
make improvements in the system, it is essential to understand how the parts of the system interact.
Process management involves stability, capability, and targeting, which require management of
variation. (see ISO 9004:2000, clause 7.5.1.1).
Figure 1 — Model of a process-based quality management system
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process improvements in health service organizations
0.2.1 Primary health service process
The primary beneficiary of the health service system is the patient/client (see 3.1.11). Health service
design, delivery, management and/or administration should focus ultimately on the patient/client.
For some health service organizations, the beneficiaries are individuals, communities and/or
populations, thus their focus would be on these client groups.
NOTE For health service management organizations, this applies to their members.
ISO 9004:2000 does not specifically define “what” needs to be done by a health professional (see
3.1.13). That is to be done by consensus of appropriate professionals based upon medical findings.
Rather, ISO 9004:2000 can be used to ensure that the right activities are carried out consistently and
in a controlled manner.
The primary health service process, with the patient/client (see 3.1.11) depicted as the customer (see
3.1.3), is shown in the diagram below. The basic product (see 3.1.14) of the health service delivery
organization in this diagram is the planning, design, and delivery of patient/client care. This model
would also apply to other health service processes, for example education and training for
preventive/wellness medicine. Design-responsibility (see 7.3), asterisked below, is either with the
customer or the supplier. If the customer does not provide the design, then the supplier is design
responsible, even if they choose to subcontract the design to an outside organization or health
professional (see 3.1.13). The care plan (see 3.1.2) and clinical guidelines are examples of quality
system documentation, while the patient/client health record (see 3.1.12) is an example of a quality
record.
For organizations that elect to be third-party certified against the requirements of ISO 9001:2000,
particular attention should be given to define an accurate scope of the certification to ensure that all
appropriate elements, for example design (see 7.3) are included. Also, due consideration should be
given to Clauses 1.1 Scope and 1.2 Application of ISO 9001:2000, which are not included in this
document.
NOTE It is emphasized that ISO 9000:2000 clause 3.4.4 defines ‘design and development’ as
the ‘set of processes that transforms requirements into specified characteristics or
into the specification of a product, process or system.’
The care plan (see 3.1.1) and clinical guidelines are examples of quality system documentation,
while the patient/client health record (see 3.1.11) is an example of a quality record.
xii © Copyright 2000, 2004, 2005 ISO, AIAG
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process improvements in health service organizations
Manage
* Design &
Planning
Development
Patient during
Patient/Client
Delivery/ & after Health
Diagnosis
seeking Health
Administration
Service
Service
Monitoring
Support
Figure 2: Model for Health Service Organizations with Patient/Client as “Customer”
* See 7.3 Design and development
0.3 Relationship with ISO 9001
See ISO 9004:2000.
This International Standard does not include guidance specific to other management systems, such as those
particular to environmental management, occupational health and safety management, financial management,
or risk management. However, this International Standard enables an organization to align or integrate its own
quality management system with related management systems. It is possible for an organization to adapt its
existing management system(s) in order to establish a quality management system that follows the guidelines
of this International Standard.
Each section of this document is tied to its counterpart in ISO 9004:2000 containing all the
requirements of ISO 9001:2000. This provides additional guidance for full compatibility between
the ISO 9000 standards and the resulting quality system.
0.4 Introduction
This document was developed with the following objectives:
• Improve delivered health service quality and safety to complement existing accreditation or to
aid in achieving accreditation
• Provide process improvements to increase the value added to the organization and customer (see
3.1.2)
• Improve the image of the organization, increase customer confidence and have a tool to reward
quality
• Maintain consistency in the global approach with TS-16949 and other ISO 9000 sector-specific
documents, for example aerospace (AS-9100), medical devices (ISO 13485), telecommunications
(TL-9000), and medical laboratories (ISO 15189).
• Develop/incorporate a process that is actionable
• Minimize/reduce burden on health service organizations.
© Copyright 2000, 2004, 2005 ISO, AIAG xiii
process improvements in health service organizations
Any relevant health service accreditation criteria external to the organization should be used in
conjunction with this document. The organization can include additional requirements to further
define and/or document the quality management system as appropriate (for example use of quality
award criteria).
xiv © Copyright 2000, 2004, 2005 ISO, AIAG
Quality Management Systems — Guidelines for IWA 1:2005(E)
process improvements in health service organizations
Quality Management Systems — Guidelines for process improvements
in health service organizations
Quality management systems — Guidelines for performance
improvements
1 Scope
This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to
consider both the effectiveness and efficiency of a quality management system, and consequently the
potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives
of customer satisfaction and product quality are extended to include the satisfaction of interested parties and
the performance of the organization.
This International Standard is applicable to the processes of the organization and consequently the quality
management principles on which it is based can be deployed throughout the organization. The focus of this
International Standard is the achievement of ongoing improvement, measured through the satisfaction of
customers and other interested parties.
This International Standard consists of guidance and recommendations and is not intended for certification,
regulatory or contractual use, nor as a guide to the implementation of ISO 9001.
1.1 Scope - Health service additions
This document provides additional guidance for any health service organization (see 3.1.8) involved
in the management, delivery, or administration of health service products or services, including
training and/or research, in the life continuum process for human beings, regardless of type, size and
the product or service provided.
NOTE ISO 13485 and ISO/IEC 17025 provide specific information for medical device
organizations and commercial laboratory facilities. ISO 15189 provides specific
information for medical (clinical) laboratories. Other organizations, such as
manufacturers/distributors of pharmaceuticals, medical supplies are regulated and
have to comply with other specified criteria. This document could be viewed
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