SIST-TS IWA 1:2007
(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
Relations
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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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 . 4
...
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