IWA 1:2001

Quality management systems — Guidelines for process improvements in health service organizations

Systèmes de management de la qualité — Lignes directrices pour l'amélioration des procédés dans les organisations des services de santé

General Information

• Status: Withdrawn
• Publication Date: 19-Sep-2001
• Withdrawal Date: 19-Sep-2001
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.020 - Medical sciences and health care facilities in general
• Technical Committee: ISO/TMBG - Technical Management Board - groups
• Drafting Committee: ISO/TMBG - Technical Management Board - groups
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 03-Oct-2005

Relations

• Revised: IWA 1:2005 - Quality management systems — Guidelines for process improvements in health service organizations
• Effective Date: 15-Apr-2008
• Revised: SIST-TS IWA 1:2007 - Quality management systems -- Guidelines for process improvements in health service organizations
• Effective Date: 12-May-2008

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, 2000-12-15
Quality management systems —
Guidelines for performance improvements
©
ISO 2001
All rights reserved
Reference number
IWA 1:2001(E) Corrected 2001-12-01

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IWA 1:2001(E)


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©
ISO 2001
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ii © ISO 2001 – All rights reserved

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IWA 1:2001(E)

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.

© ISO 2001 – All rights reserved iii

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Quality Management Systems — Guidelines for process
IWA 1:2001(E)
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
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IWA 1:2001(E) Quality Management Systems — Guidelines for process
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
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Quality Management Systems — Guidelines for process
IWA 1:2001(E)
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

© ISO 2001 – All rights reserved 3

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IWA 1:2001(E) Quality Management Systems — Guidelines for process
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, Daimler
...