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Basic data
| Standard ID | RB/T 161-2017 (RB/T161-2017) |
| Description (Translated English) | (Quality management system Health care equipment distribution service requirements) |
| Sector / Industry | Chinese Industry Standard (Recommended) |
| Classification of Chinese Standard | A00 |
| Word Count Estimation | 24,294 |
| Date of Issue | 2017-05-27 |
| Date of Implementation | 2017-12-01 |
| Regulation (derived from) | National Standard Division (2017) 64; Industry Standard Filing Announcement 2017 No. 7 (Total No. 211) |
| Issuing agency(ies) | National Certification and Accreditation Administration |
RB/T 161-2017: (Quality management system Health care equipment distribution service requirements)
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Quality management system Health care equipment distribution service requirements)
ICS 03.120.20
A00
Record number. 58851-2017
People's Republic of China certification and recognition of industry standards
Quality management system
Health care equipment distribution service requirements
Released on.2017-05-27
2017-12-01 implementation
China National Certification and Accreditation Administration issued
Content
Foreword III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Organizational Environment 1
4.1 Understanding the organization and its environment 1
4.2 Understanding the needs and expectations of interested parties 2
4.3 Determining the scope of the quality management system 2
4.4 Quality Management System and Process 2
5 Leadership 3
5.1 Leadership and Commitment 3
5.2 Policy 3
5.3 Roles, responsibilities and authorities within the organization 3
6 Planning 4
6.1 Measures to address risks and opportunities 4
6.2 Planning of quality objectives and their implementation 4
6.3 Planning for change 4
6.4 Compliance obligations 5
7 support 5
7.1 Resources 5
7.2 Ability 6
7.3 Consciousness 6
7.4 Communication 6
7.5 written information 7
8 running 7
8.1 Planning and Control of Distribution Services 7
8.2 Distribution Service Requirements 7
8.3 Design and development of health care distribution services 8
8.4 Control of procurement and outsourcing processes 9
8.5 Delivery, storage, customer experience, sales and delivery tracking 10
8.6 Service release 12
8.7 Control of unqualified output 12
9 Performance Evaluation 13
9.1 Monitoring, measurement, analysis and evaluation 13
9.2 Internal Audit 13
9.3 Management Review 14
10 Improvement 14
10.1 General 14
10.2 Failure and corrective action 14
10.3 Continuous Improvement 14
Appendix A (informative appendix) Health equipment distribution service organization internal and external environment 15
Reference 19
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is proposed and managed by the National Certification and Accreditation Administration.
The framework of this standard is consistent with GB/T 19001-2016 "Quality Management System Requirements".
This standard was drafted. Beijing World Standard Certification Center Co., Ltd., China Health Care Association Health Service and Research Committee, China Health
Health Law Magazine, China Health Supervision Association, China Health Care Association Equipment Health Products Branch, China Medical Device Industry Association Medical Insurance
Health Products Professional Committee, Beijing University of Traditional Chinese Medicine Wudang Medical Research Institute, Beijing Ruiqi Ning Biotechnology Co., Ltd., Beijing Zhongjianhui Health
Management Co., Ltd., Heyiyuan (Beijing) Medical Research Institute, Beijing Oriental Desi Technology Co., Ltd., Hangzhou Haizi Commodity Co., Ltd., Guangdong
Kasler Technology Development Co., Ltd., Jiangsu Longliqi Biotechnology Co., Ltd., Shandong Kangtai Industrial Co., Ltd.
The main drafters of this standard. Xu Tao, Li Yongbo, Xu Chao, Gai Ruyu, Zhang Lili, Li Ping, Zheng Shouzeng, Qu Yanying, Chi Yongzhen, Zhou Liqun,
Yang Qiuli, Yang Kunrong, Cai Tianzhi, Li Xia, Che Zhijun, Liu Guanghe, Lu Yihong, Sun Zhujun, Wang Yuan, Wu Qing, Jin Yiping, Zhang Jingsheng, Pan Chengsen,
Tian Xiangdong.
Introduction
With the increasing demand for health care equipment and the continuous development of the health care equipment industry, the types of health care equipment products are
Increasingly, sales are also increasing year by year, but the development of China's health care equipment industry is not balanced, and there is competition and disorder in the health care equipment market.
The standards are vague, some operators are not standardized in their business practices, and they mislead consumers, even if they are entrusted by production plants, and have no licenses and illegal operations.
It has seriously affected the rapid and healthy development of the health care equipment industry. At the same time, there are fewer laws and regulations applicable to health care equipment in China, especially for
There are fewer laws and regulations on health care device distribution services. The lack of national standards, industry standards and industry norms to enter the city
The opportunity provided an opportunity to hinder the sustainable development of the healthcare device industry.
The purpose of this standard is to establish a unified, industry-specific and targeted quality management system in the health care equipment distribution service industry.
The system requires to guide and assist organizations engaged in health care equipment distribution services to establish a systematic, scientific, reasonable and operational
Quality management system, implement continuous improvement, realize the management goal of distribution service, promote the standardized development of health care equipment distribution service industry, improve insurance
The quality of health equipment distribution services truly provides customers with safe, effective, high quality and reliable products and services.
This standard is based on GB/T 19001-2016 "Quality Management System Requirements", combined with the characteristics and requirements of health care equipment distribution services.
Standardization is the basic principle for establishing a quality management system for the health care equipment distribution service industry.
This standard focuses on and adopts existing national standards, laws and regulations related to the health care equipment distribution service industry, and maintains coordination with it.
Sex and consistency. This standard sets out the specific requirements for the quality management system of health care equipment distribution service organization.
When this standard is used for certification purposes, it should be used together with GB/T 19001-2016 "Quality Management System Requirements" to constitute a health care device.
Distribution service organization quality management system certification basis.
Quality management system
Health care equipment distribution service requirements
1 Scope
This standard specifies the requirements for the quality management system of health care equipment distribution service organization.
This standard applies to the establishment, implementation, maintenance and improvement of its quality management system by the Health Care Equipment Distribution Service Organization (hereinafter referred to as the “Organization”).
Can be used as a basis for the organization to implement self-evaluation and self-declaration, or as a basis for the organization's health care equipment distribution service quality management system.
Basis for evaluation and certification.
2 Normative references
The following documents are indispensable for the application of this standard. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 19000-2016 Quality Management System Foundation and Terminology
GB/T 19001-2016 Quality Management System Requirements
3 Terms and definitions
The following terms and definitions defined in GB/T 19000-2016 apply to this document.
3.1
Health care equipment healthcareequipment
It has the functions of relieving fatigue, promoting health, preventing diseases, regulating body functions and other health functions, and does not aim at treating diseases.
Note. Health equipment includes massage equipment, health examination equipment, home physiotherapy equipment, rehabilitation equipment, fitness equipment, beauty and body care, drinking water care, air
Purification class, etc., does not include medical equipment.
3.2
Health care equipment distribution service healthcareequipmentdistributionservice
Organizing one or more processes for distributing health care devices, at least one of which must be provided between the organization and the customer.
Note 1. Health care equipment distribution services include procurement, distribution to distribution, storage, customer experience, sales, delivery tracking, after-sales service and other processes.
Note 2. Rewrite GB/T 19000-20163.7.7.
3.3
Customer experience customerexperience
The customer experiences the function and performance of the health care device through sensory, emotional, thinking, action, and association through direct observation or participation.
4 organizational environment
4.1 Understanding the organization and its environment
4.1.1 The organization shall meet the requirements of 4.1 of GB/T 19001-2016.
4.1.2 The organization shall identify, monitor and review the factors in the internal and external environment. See Appendix A for the internal and external environment of the organization.
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