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Quality management systems -- Guidelines for process improvements in health service organizations
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Basic data | Standard ID | GB/Z 19031-2009 (GB/Z19031-2009) | | Description (Translated English) | Quality management systems -- Guidelines for process improvements in health service organizations | | Sector / Industry | National Standard | | Classification of Chinese Standard | A00 | | Classification of International Standard | 03.120.10 | | Word Count Estimation | 73,775 | | Date of Issue | 2009-09-30 | | Date of Implementation | 2009-12-01 | | Quoted Standard | GB/T 19000-2008; GB/T 19011-2003 | | Adopted Standard | ISO/IWA1-2005, IDT | | Regulation (derived from) | ?National Standard Approval Announcement 2009 No.10 (Total No.150) | | Issuing agency(ies) | Ministry of Health of the People's Republic of China | | Summary | This standard specifies the excess of GB/T 19001 requirements guide. In order to be considered to improve the effectiveness and efficiency of the quality management system, and then consider the potential development of improved organizational performance. Compared with GB/T 19001, the standard will be customer satisfaction and product quality goals expanded to include stakeholders satisfaction and organizational performance. This standard applies to the processes of organizations. Therefore, the quality management principles are based on the standard can be applied throughout the organization. This standard emphasizes continuous improvement, which can be measured by customers and other interested parties satisfaction. | GBZ19031-2009: Quality management systems -- Guidelines for process improvements in health service organizations
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Quality management systems.Guidelines for process improvements in health service organizations
ICS 03.120.10
A00
People's Republic of China national standardization of technical guidance documents
GB /Z19031-2009/ISO /IWA1..2005
Quality Management System Medical Services Organization
Process Improvement Guide
(ISO /IWA1..2005, IDT)
2009-09-30 released
2009-12-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
China National Standardization Administration released
Directory
Foreword V.
Introduction Ⅵ
0.1 General Ⅵ
0.2 Process Method Ⅵ
0.2.1 Main Medical Service Process Ⅶ
0.3 and GB/T 19001 relationship Ⅷ
0.4 Purpose and Significance Ⅷ
1 Scope 1
1.1 Additional medical services 1
2 Normative references 1
3 Terms and definitions 1
3.1 Supplementary terms and definitions 1
4 quality management system 5
4.1 System and Process Management 6
4.2 Document 6
4.2.1 File Control (Supplement) 7
4.2.4 Record Control (Supplement) 9
4.3 The application of quality management principles 9
5 Management responsibilities 10
5.1 General Guidelines 10
5.1.1 Introduction 10
5.1.2 Things to consider 11
5.2 Stakeholder Needs and Expectations 12
5.2.1 General 12
5.2.2 needs and expectations 12
5.2.2.1 Medical Safety 13
5.2.2.2 Medical Benefits 13
5.2.2.3 Public Safety 13
5.2.2.4 Community Services 13
5.2.2.5 Social responsibility 13
5.2.3 Legal requirements 13
5.2.4 Patient Care 13
5.3 Quality Policy 14
5.4 Planning 15
5.4.1 Quality Objectives 15
5.4.2 Quality Planning 16
5.4.3 Business Planning 16
5.4.4 Prevention Mistakes 17
GB /Z19031-2009/ISO /IWA1..2005
5.5 Responsibility, authority and communication 18
5.5.1 Responsibility and authority 18
5.5.1.1 Duties and authorities (Supplementary) 18
5.5.2 Manager's Representative
5.5.3 Internal Communication 19
5.6 Management Review 20
5.6.1 General 20
5.6.2 Review input 20
5.6.3 Review Output 21
6 Resource Management 22
6.1 General guidelines 22
6.1.1 Introduction 22
6.1.2 Things to consider 22
6.1.2.1 Shift Staff Management 22
6.2 staff 22
6.2.1 Personnel Involvement 22
6.2.2 Competence, awareness and training 23
6.2.2.1 Ability 23
6.2.2.1.1 Education and Health 24
6.2.2.1.2 Quality Management Qualifications and Professional Qualifications 24
6.2.2.1.3 Communication skills 24
6.2.2.2 Awareness and training 24
6.2.2.2.1 On-the-job training 25
6.2.2.2.2 Identify patient and family education and training programs
6.3 Infrastructure 25
6.3.1 Treatment of medical waste 26
6.4 working environment 26
6.5 Information 27
6.6 Suppliers and partnerships 27
6.6.1 Provide Purchased Products 27
6.7 Natural Resources 27
6.8 Financial resources 27
7 product realization 28
7.1 General guidelines 28
7.1.1 Introduction 28
7.1.2 Things to consider 29
7.1.3 Management Process 29
7.1.3.1 General 29
7.1.3.2 Process Input, Output and Review 30
7.1.3.2.1 Planning of the realization process
7.1.3.3 Product and Process Validation and Change 31
7.2 Process Related to Stakeholders 33
7.2.1 Contract Review 33
GB /Z19031-2009/ISO /IWA1..2005
7.3 Design and Development 34
7.3.1 General guidelines 34
7.3.1.1 Design Process 34
7.3.2 Design and Development Inputs and Outputs 34
7.3.2.1 Planning of Facilities and Equipment 35
7.3.3 Design and Development Review 36
7.3.3.1 Selection of treatment methods 37
7.4 Purchasing 39
7.4.1 Procurement Process
7.4.1.1 Purchase Control 39
7.4.1.2 Urgent Need for Purchased Products 39
7.4.2 Process of Controlling Suppliers 39
7.4.2.1 Scheduled suppliers 39
7.4.2.2 Subcontracting Services 40
7.5 Production and service operations 41
7.5.1 Operation and Implementation 41
7.5.1.1 Management of Patient Care 41
7.5.1.2 Maintenance 42
7.5.2 Identification and Traceability 42
7.5.3 Customer Property 43
7.5.4 Product Protection 44
7.5.4.1 Product Protection (Supplement) 44
7.6 Measurement and monitoring device control 45
7.6.1 Measurement and Monitoring Device Control (Supplement) 45
Measurement, Analysis and Improvement
8.1 General guidelines 46
8.1.1 Introduction 46
8.1.1.1 Planning of Measurement 46
8.1.2 Things to consider 46
8.2 Measurement and monitoring 47
8.2.1 Measurement and monitoring of system performance 47
8.2.1.1 General
8.2.1.2 Customer Satisfaction Measurement and Monitoring 47
8.2.1.2.1 Customer Satisfaction Measurement and Monitoring (Supplement) 48
8.2.1.3 Internal Audit 49
8.2.1.3.1 Audit Scheme 49
8.2.1.4 Financial Measurement 50
8.2.1.5 Self-assessment 50
8.2.2 Process Measurement and Monitoring 50
8.2.2.1 Process Measurement and Monitoring (Supplement) 51
8.2.3 Measurement and Monitoring of Products 51
8.2.3.1 Product Measurement and Monitoring (Supplement) 52
8.2.4 Measurement and monitoring of the satisfaction of interested parties 52
GB /Z19031-2009/ISO /IWA1..2005
8.3 Uncontrolled Controls 53
8.3.1 General 53
8.3.1.1 Disposal of nonconforming product 53
8.3.2 Unqualified Accreditation and Disposal 53
8.4 Data Analysis 54
8.5 Improvement 55
8.5.1 General 55
8.5.1.1 General (Supplement) 55
8.5.2 Corrective Action 56
8.5.2.1 Corrective Action Process
8.5.3 Prevention of loss 57
8.5.4 Continuous Improvement of the Organization 58
Appendix A (informative) self-assessment guide 60
Appendix B (informative) process of continuous improvement 61
References 62
GB /Z19031-2009/ISO /IWA1..2005
Foreword
The purpose of this technical paper is to help medical service organizations establish, implement and improve quality management systems to continuously improve healthcare
Service quality, so that customers (patients and their families, etc.) and other stakeholders more satisfied.
Rather than merely interpreting the GB/T 19000 series of medical service organizations, this guidance document provides a detailed
guide. The examples, terms, and definitions in this technical document are representative of the healthcare services industry and are heavily used
Other specialized terms often used in the hospitality industry.
The layout of the guidance of technical documents. the box is GB/T 19001-2008 content, the box is the background color
GB/T 19004-2000 content, which is applied to any organization of two universal standards. The rest is an addition to this document,
The purpose is to help medical service organizations to meet their particularities. The terms of this technical document and GB/T 19001-2008 and
GB/T 19004-2000 clause number is the corresponding. Among them, 4.2.2 and 4.2.3 there is no specific guideline, so its clause number
delete.
If a medical service organization can seriously implement this guidance document and maintain the effective operation of the quality management system,
His experience in his industry will have very clear results in improving the quality of medical services and increasing customer satisfaction.
As the guidance of technical documents for the implementation of GB/T 19001 standards of quality management system, therefore, intends to use
GB/T 19001 standard medical service organizations, if the use of the guidance of technical documents, than the direct use as a basis for certification
GB/T 19001 much more convenient.
This guidance document is equivalent to ISO /IWA1..2005 Quality Management System Medical Service Organization Process Improvement Guidelines.
This Guidance Document is an integral part of and consistent with the GB/T 19000 series of standards.
In the text of this Guidance Document, the names and numbers of international standards listed in the original texts, which have been translated into national standards, are listed in the
Home standard name and number, did not translate into national standards, then list the international standards or their data number and Chinese translation.
The appendix A and appendix B of this technical document are the same as appendix in GB/T 19004-2000,
appendix.
This Guidance Document is proposed and managed by the National Quality Management and Quality Assurance Standardization Technical Committee (SAC/TC151).
This guiding technical document drafting units. China National Institute of Standardization, China National Accreditation Service for Conformity Assessment, China Certification and Accreditation Association,
Beijing Branch by the Central Quality Certification Company, Beijing New Century Certification Co., Ltd., Beijing Union Medical College Hospital.
The main drafters of this Guidance Technical Paper. Li Jing, Gu Yanjun, Mu Jin, Lv Yan, Chen Key, Chen Qiu Rui, Hao Xinhua.
This guideline is for reference only. For advice and comments on this technical document, please contact the Director of Standardization Administration of the State Council
Department reflected.
GB /Z19031-2009/ISO /IWA1..2005
Introduction
The purpose of this guidance document is to assist health care organizations (see 3.1.8) to establish or improve a basic quality management system. with
, Advocate continuous improvement, emphasizing prevention of errors or bad outcomes, reducing the risk of instability and waste, such as worthless additional activities.
This guidance document incorporates the contents of GB/T 19004-2000 "Guidelines for Performance Improvement in Quality Management Systems" and provides
A guide to a quality management system that includes satisfactory continuous improvement processes for customers and other stakeholders in healthcare services. Quality management body
Should be able to make all customers satisfied with the medical products, expertise or medical services provided by medical service organizations.
0.1 General
See GB/T 19004-2000.
0.2 process method
This standard encourages the establishment and implementation of quality management system and improve its effectiveness and efficiency, the use of process approach, by meeting the relevant
Party requirements, to enhance the satisfaction of interested parties.
In order for an organization to function effectively and efficiently, it is important to identify and manage the many interrelated activities. Enter by using resources and management
Activities converted to output can be considered as processes. Often, the output of one process directly forms the input to the next process.
The application of systems of processes within the organization, together with the identification and interaction of these processes and their management, can be referred to as a "process approach."
The advantage of a process approach is the continuous association of the individual processes in the processes of the processes and the combination and interaction of the processes
control.
The health care service should determine all its processes. These processes are typically multidisciplinary and include management, diagnostics and services
Other support services, for example.
a) Identify and provide training based on the needs of personnel competencies and qualifications;
b) Surgical treatment, adjuvant therapy, supportive therapy and necessary service assurance;
c) Take control and preventive measures;
d) use evidence-based medicine;
e) Appropriately fill in and number the medical service (eg according to the diagnosis classification and case type);
f) Nursing patients continuously in any environment and place.
The use of process approaches in quality management systems emphasizes the importance of.
a) understand and meet the requirements;
b) The process needs to be considered from a value added perspective;
c) the outcome of the process's performance and effectiveness;
d) continuous improvement process based on objective measurements.
The process-based quality management system model shown in Figure 1 shows the process links presented in Chapters 4-8. This show
It reflects that the relevant parties play an important role in stipulating the import requirements; the monitoring requirements that are satisfactory to the interested parties are complete for the relevant organizations concerned
Evaluate the information that suits their feelings. The patterns of Figure 1 do not reflect the processes in detail.
All work can be seen as a process, and is part of the system (see GB/T 19000-2008, 3.2.1). To improve
System, it is necessary to understand how the various parts of the system interact with each other. Process management includes the stability, ability and goals required for such changes
Management (see GB/T 19004-2000, 7.1.3).
GB /Z19031-2009/ISO /IWA1..2005
Emoticons.
Value-added activities
Information Flow
Figure 1 Process-based quality management system model
0.2.1 The main medical service process
The main beneficiaries of the medical service quality management system are patients (see 3.1.11) and their families, and therefore, the design, delivery and management of medical services
The ultimate focus of reason should be on patients and their families. For some medical service organizations, the beneficiaries are individuals, communities and residents, so these medical
Service organizations should focus on these groups.
Note. This section applies to subordinate members of the medical service administration.
GB/T 19004-2000 does not specifically provide medical professionals (see 3.1.13) how to carry out the treatment of the technical work. These ones
Activities will be carried out by the corresponding professionals based on the consensus of medical diagnosis. The GB/T 19004-2000 can be used to ensure that the correct
The activities are always carried out in a controlled manner.
In Figure 2, patients (see 3.1.11) and their dependents in the primary care process are treated as customers (see 3.1.3). In this figure, medical treatment is provided
The basic product of a tissue care service (see 3.1.14) is to plan, design and deliver services to patients and their families. This model also applies to it
His medical service process. Examples include education and training in disease prevention and rehabilitation. The design of an asterisk in Figure 2 is the responsibility (see 7.3)
So customers or medical service organizations. If the customer does not provide the design, the design responsibility is in the organization, even if the organization subcontracts the design to others
Department of tissue or medical professionals (see 3.1.13), the responsibility of the design is still in the medical service organization. Treatment plan (see 3.1.2) and clinical means
Guidance is an example of a quality system document, and a patient treatment record (see 3.1.12) is an example of a quality record.
For organizations to choose third-party certification for GB/T 19001-2008 requirements, special attention should be paid to determine the exact scope of certification to
Be sure to cover all appropriate aspects such as design (see 7.3). Should also take due consideration of the guidance of technical documents do not include,
GB/T 19001-2008 "1.1 General" and "1.2 Application" given in the content.
Note. It should be emphasized that in GB/T 19000-2008 3.4.4 design and development is defined as "the requirements into the provisions of the product, process or system
A set of processes of characteristics or specifications ".
GB /Z19031-2009/ISO /IWA1..2005
a See 7.3 Design and Development.
Figure 2 Health services model patients and their families as "customers."
0.3 and GB/T 19001 relationship
See GB/T 19004-2000.
This standard does not include guidelines for other management systems such as environmental management, occupational health and safety management, financial management or risk management
Unique guide. However, this standard enables an organization to integrate or integrate its own quality management system with an associated management system. Organized as
Establishing a quality management system that follows this guideline may change the existing management system.
Each chapter of the guidance of technical documents have corresponding GB/T 19004-2000 in the content, including the corresponding end
Whole GB/T 19001-2008 requirements. This is to establish and implement a quality management system fully in line with GB/T 19001 standards
The guide.
0.4 purpose and meaning
This guidance document establishes the following objectives.
--- improve the quality and safety of medical services to achieve or increase the recognition of medical service organizations;
--- Promote process improvement to increase the value of healthcare organizations and customers (see 3.1.3);
--- Improve the image of medical service organizations, increase customer trust and reward high-quality medical services;
--- Guidance with GB/T 18305 and GB/T 19000 in other industries such as Aerospace (HB9100), Medical Devices
(YY/T 0287), Telecommunications (TL9000) and Medical Laboratories (ISO 15189) in a holistic approach;
--- Determine and increase the special requirements of the industry process;
--- Minimize the burden on medical service organizations.
The medical service organization should incorporate this guidance document along with other external standards for any healthcare service. appropriate
, Health care organizations can add new content (such as using Quality Award criteria) to future QMS documents and definitions.
GB /Z19031-2009/ISO /IWA1..2005
Quality Management System Medical Services Organization
Process Improvement Guide
1 Scope
This standard provides guidance beyond the GB/T 19001 requirements in order to consider improving the effectiveness and efficiency of the quality management system, and then test
Consider developing the potential to improve organizational performance. Compared with GB/T 19001, this standard extends customer satisfaction and product quality objectives to include
Satisfied parties and the performance of the organization.
This standard applies to the organization of the various processes, therefore, this standard is based on the principle of quality management can also be applied throughout the organization. This standard
Quasi-emphasis on achieving continuous improvement can be measured by the satisfaction of customers and other stakeholders.
This standard includes guidelines and recommendations, neither intended for certification, statutory or contractual purposes, nor GB/T 19001 implementation guidelines.
1.1 Additional medical services
This guidance document provides guidance for any healthcare service organization (see 3.1.8), including the management, provision or operation of health care services,
It also includes scientific research and training in the human life processes, whether they are products or services, regardless of their type and size.
Note. YY/T 0287-2003 and GB/T 27025-2008 provide specialized information on medical device organization and commercial laboratory facilities. ISO 15189 right
(Clinical) medical laboratory provides specialized information. Other organizations, for example. Manufacturers and distributors of pharmaceuticals, medical supplies must comply with the regulations Other
Professional standards. If some organizations choose this guidance document as an implementation guide, this guidance document should be used as a voluntary supplement
document.
Medical professional terms and definitions, such as. patients and their families, primary, secondary and special care, etc., due to different medical services
The area is different. These activities are all medical service organization processes that should be included in the quality management system. This guidance document
The recommendations and guidance in this section apply to the quality of products or services that affect the organization within a health care organization, including the necessary support services (see
3.1.23) any one person.
2 Normative references
The following standards contain provisions that, through reference in this standard, constitute provisions of this standard. This standard was published, the version shown are
To be effective. All standards will be revised, the parties using this standard should explore the possibility of using the latest version of the following standards.
GB/T 19000-2008 Quality Management System Fundamentals and Terminology (ISO 9000..2005, IDT)
GB/T 19011-2003 Quality and/or Environmental Management System Audit Guidelines (ISO 19011..2002, IDT)
3 Terms and definitions
This standard uses the terms and definitions in GB/T 19000.
The following terms used in the standard expression supply chain have been changed to reflect the current situation.
→ → Supplier organizes customer (party)
The term "product" appearing in this standard may also refer to "service."
3.1 Supplementary terms and definitions
This guideline is defined in GB/T 19000-2008. When certain terms are defined in the wording
GB/T 19000-2008 different definitions, the use of the definition of the guidance of technical documents.
3.1.1
Any event that does not match the organization's wishes, stated status, or usual status
Serious adverse events to be recorded, and asked to write an accident report. Such serious nonconformities are also called "medical accidents" and require
GB /Z19031-2009/ISO /IWA1..2005
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