IWA 1:2001

International Workshop Agreement
IWA 1
Quality Management Systems —
Guidelines for process improvements
in health service organizations
** **
Based on ISO 9004:2000,
Second edition, 2000-12-15
Quality management systems —
Guidelines for performance improvements
©
ISO 2001
All rights reserved
Reference number
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ISO 2001
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ii © ISO 2001 – All rights reserved

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years, transferred to an ISO technical body for revision, or withdrawn.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ISO technical body or withdrawn.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.

Quality Management Systems — Guidelines for process
improvements in health service organizations

Contents Page
Foreword - Supplemental . 4
Introduction . . 5
0.1 General . 5
0.2 Process approach. 5
0.2.1 Primary Health service Process. 6
0.3 Relationship with ISO 9001. . 7
0.4 Compatibility with other management systems . 8
0.5 Introduction – Quality Standards, ISO and Health services . 8
1 Scope . 8
1.1 Scope – Health services additions . 9
2 Normative reference . . 9
3 Terms and definitions . . 9
3.1 Terms and definitions - Supplemental . . 9
4 Quality management system . . 13
4.1 Managing systems and processes . 13
4.2 Documentation . 14
4.2.1 Control of documents - Supplemental . . 16
4.2.2 Control of records - Supplemental . 16
4.3 Use of quality management principles . . 17
5 Management responsibility . 18
5.1 General guidance . 18
5.1.1 Introduction . .18
5.1.2 Issues to be considered . . 18
5.2 Needs and expectations of interested parties . 19
5.2.1 General . . 19
5.2.2 Needs and expectations . . 20
5.2.2.1 Product safety . 21
5.2.2.2 Product efficacy . 21
5.2.2.3 Security . 21
5.2.2.4 Community Service . 21
5.2.2.5 Social responsibility . 21
5.2.3 Statutory and regulatory requirements . 21
5.2.4 Patient/Client care practices . 22
5.3 Quality policy . 22
5.4 Planning . . 23
5.4.1 Quality objectives . . 23
5.4.2 Quality planning . . . 23
5.4.3 Business planning . . 24
5.4.4 Error proofing . . 24
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 . 25
5.5.3 Internal communication . 26
5.6 Management review . . 26
5.6.1 General . . 26
5.6.2 Review input . . 27
5.6.3 Review output . . 27
6 Resource management . . 28
6.1 General guidance . . 28
6.1.1 Introduction . . 28
6.1.2 Issues to be considered . . 28
6.1.2.1 Shift resources . . 29
6.2 People …………. . . 29
6.2.1 Involvement of people . . 29
6.2.2 Competence, awareness and training . . 30
6.2.2.1 Competence . . 30
improvements in health service organizations

6.2.2.1.1 Credentialing and health status . . . 30
6.2.2.1.2 Quality management and requalification . . 30
6.2.2.2 Awareness and training . . 30
6.2.2.2.1 Ongoing training . . 31
6.2.2.2.2 Identification of patient/client’s family education/training programs . . 31
6.3 Infrastructure . 32
6.3.1 Hazardous waste handling . 32
6.4 Work environment . . 33
6.5 Information . . 33
6.6 Suppliers and partnerships . .34
6.6.1 Supply – Purchased product . .34
6.7 Natural resources . . 34
6.8 Financial resources . . 34
7 Product realization . . . 35
7.1 General guidance . . 35
7.1.1 Introduction . . . 35
7.1.2 Issues to be considered . . 35
7.1.3 Managing processes . . 36
7.1.3.1 General . . 36
7.1.3.2 Process inputs, outputs and review . . 36
7.1.3.2.1 Planning of realization processes . . . 37
7.1.3.3 Product and process validation and changes . . 38
7.2 Processes related to interested parties . 39
7.2.1 Contract review . . . 40
7.3 Design and development . . 40
7.3.1 General guidance . . 40
7.3.1.1 Design process . . . 40
7.3.2 Design and development input and output . . 41
7.3.2.1 Facility and equipment planning . . . 42
7.3.3 Design and development review . . 43
7.3.3.1 Selecting care approaches . . . 44
7.4 Purchasing . . 44
7.4.1 Purchasing process . . 44
7.4.1.1 Purchasing control . . 45
7.4.1.2 Urgently needed purchased product . . 45
7.4.2 Supplier control process . . 45
7.4.2.1 Pre-determined suppliers . . 46
7.4.2.2 Subcontracted services . . 46
7.5 Production and service operations . 47
7.5.1 Operation and realization . 47
7.5.1.1 Manage patient/client care processes . . . 47
7.5.1.2 Servicing . . 48
7.5.2 Identification and traceability . 48
7.5.3 Customer property . 49
7.5.4 Preservation of product . 50
7.5.4.1 Preservation of product - Supplemental . . 50
7.6 Control of measuring and monitoring devices . 50
7.6.1 Control of measuring and monitoring devices - Supplemental . 51
8 Measurement, analysis and improvement . 52
8.1 General guidance . 52
8.1.1 Introduction . . 52
8.1.1.1 Planning measurement . . 52
8.1.2 Issues to be considered . . 52
8.2 Measurement and monitoring . 53
8.2.1 Measuring and monitoring of system performance . . 53
8.2.1.1 General . 53
8.2.1.2 Measurement and monitoring of customer satisfaction .…………………………………………… 53
8.2.1.2.1 Measurement and monitoring of customer satisfaction-Supplemental . . ……………. 54
8.2.1.3 Internal Audit . . 55
2 © ISO 2001 – All rights reserved

Quality Management Systems — Guidelines for process
improvements in health service organizations

8.2.1.3.1 Strategic Auditing . . 56
8.2.1.4 Financial measures . . 56
8.2.1.5 Self-assessment . . 56
8.2.2 Measuring and monitoring of processes . . 56
8.2.2.1 Measuring and monitoring of processes – Supplemental . . 57
8.2.3 Measuring and monitoring of product . . 57
8.2.3.1 Measuring and monitoring of product - Supplemental . . 58
8.2.4 Measuring and monitoring of satisfaction of interested parties . . 58
8.3 Control of nonconformity . . 59
8.3.1 General . . 59
8.3.1.1 Handling of nonconforming product . . 59
8.3.2 Nonconformity review and disposition . . 60
8.4 Analysis of data . . 60
8.5 Improvement . . 61
8.5.1 General . . 61
8.5.1.1 General - Supplemental . . 61
8.5.2 Corrective action . . 62
8.5.2.1 Corrective action process . . 63
8.5.3 Loss prevention . . 63
8.5.4 Continual improvement of the organization . . 64

Annexes
A Guidelines for self-assessment . 66
B Process for continual improvement . 67

Bibliography . . 68

improvements in health service organizations

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 who participated in preparation of this document:
Bruce Bradley, General Motors;
Adam Miller, UAW;
Carol Sauwen, General Motors;
Don Longnecker, DaimlerChrysler;
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).

Foreword
See ISO 9004:2000.
4 © ISO 2001 – All rights reserved

Quality Management Systems — Guidelines for 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
prevention, the reduction of variation and organizational waste, e.g. 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 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:
a) the development and delivery of training to educate
b) the surgical process for patient/clients needing surgery
c) the preventive and corrective maintenance program for equipment and facilities
d) the diagnosis and development of a care plan
e) the preparation of the billing and coding for services rendered
f) the continued care of a patient/client in any setting
g) the counseling of a patient/client and family

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
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.
improvements in health service organizations

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

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.

NOTE For health service management organizations, this applies to their members.

ISO 9000 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. Rather, ISO 9000 can be used to ensure that the right activities
are carried out consistently and in a controlled manner.

6 © ISO 2001 – All rights reserved

Quality Management Systems — Guidelines for process
improvements in health service organizations

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, e.g. 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,
e.g. 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.

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.
improvements in health service organizations

0.4 Compatibility with other management systems

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 including text boxes 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.

0.5 Introduction
This document was developed with the following objectives:
• Improve delivered health service quality and safety through: 1) complement existing accreditation and
2) 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, e.g.
aerospace (AS-9100), medical devices (ISO 13485), telecommunications (TL-9000), and medical laboratories
(ISO/DIS 15189).
• Develop/incorporate a process that is actionable
• Minimize/reduce burden on 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 it deems appropriate (e.g. use of quality award criteria).

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.

8 © ISO 2001 – All rights reserved

Quality Management Systems — Guidelines for process
improvements in health service organizations

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 17025 provide specific information for medical device organizations and
commercial laboratory facilities. ISO/DIS 15189 provides specific information for medical (clinical)
laboratories. Other organizations, such as manufacturers/distributors of pharmaceuticals, medical
supplies, etc. are regulated and have to comply with other specified criteria. This document could be
viewed as a voluntary supplement to those organizations should they choose to implement the guidance of
this document.
The definitions of terms such as patient/client, client, primary, ancillary, and specialty care vary by region within the
health service community. The organization’s processes for addressing these activities should be included in the
quality management system. The recommendations and guidance in this document apply to anyone in the
organization affecting quality, including necessary support services (see 3.1.23).

Each section of this document is tied to its counterpart in ISO 9004:2000 including text boxes 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.

2 Normative reference
The following normative document contains provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent edition of the normative document indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.

ISO 9000:2000, Quality management systems — Fundamentals and vocabulary.

3 Terms and definitions
For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.

The following terms, used in this edition of ISO 9004 to describe the supply-chain, have been changed to reflect the
vocabulary currently used:
supplier   organization   customer (interested parties)

Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.

3.1 Terms and definitions – Supplemental
For purposes of this document, the definitions in ISO 9000:2000 Quality mangement systems – Fundamentals and
vocabulary apply. However where there are terms for which the wording of the definition of the term differs in
ISO 9000:2000, the definitions herein apply.

3.1.1
adverse event
any event which is not consistent with the desired, normal or usual operation of the organization. Typically these
are documented and require the completion of an incident report. Such serious non-conformance can also be
...