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

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.

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Withdrawn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
31-Mar-2007
Withdrawal Date
19-Jan-2015
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
16-Jan-2015
Due Date
08-Feb-2015
Completion Date
20-Jan-2015

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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
IWA 1:2005(E) All rights reserved
---------------------- Page: 1 ----------------------
IWA 1:2005(E)
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ASQ (Healthcare Division), copyrighted by AIAG and then submitted for consideration

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dashed boxes directly in this publication, as well as in derivative publications of ISO’s

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© ISO 2005

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,

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ii © ISO 2005 – All rights reserved
---------------------- Page: 2 ----------------------
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

© ISO 2005 – All rights reserved iii
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IWA 1:2005(E) Quality Management Systems — Guidelines for
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
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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

© ISO 2005 – All rights reserved v
---------------------- Page: 5 ----------------------
IWA 1:2005(E) Quality Management Systems — Guidelines for
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
---------------------- Page: 6 ----------------------
Quality Management Systems — Guidelines for IWA 1:2005(E)
process improvements in health service organizations
Foreword to IWA 1, 2 Edition – Supplemental

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
---------------------- Page: 7 ----------------------
IWA 1:2005(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
Margar
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