Система менеджмента качества (СМК) - это совокупность взаимосвязанных процессов и элементов организации, направленных на установление политики и целей в области качества, а также на их достижение. СМК служит для обеспечения соответствия продукции требованиям потребителей, включая медицинские изделия, и включает управление проектированием, процессами и корректирующими действиями.
| 标准号 & 类别 | 标准名称 | 发布 |
|---|---|---|
| GOST ISO 13485-2017 规范 |
Medical devices. Quality management systems. Requirements for regulatory purposes
Медицинское изделие Менеджмент риска |
2017-00-00 俄罗斯标准局 |
| GOST R 51814.7-2005 规程 |
Management quality systems for automotive industry. Management quality systems analysis
Аудит |
2005 俄罗斯标准局 |
| GOST R 53092-2008 指南标准 |
Quality management systems. Guidelines for process improvements in health service organizations
|
2008 俄罗斯标准局 |
| GOST R 54536-2011 规范 |
Quality management systems. Cross-sectoral requirements
|
2011 俄罗斯标准局 |
| GOST R 54985-2018 指南标准 |
小型企业基于ISO 9001-2008标准质量管理体系实施指南 Guidelines for small businesses on implementation of quality management system based on ISO 9001:2008
|
2018-01-01 俄罗斯标准局 |
| GOST R 55270-2012 指南标准 |
Quality Management Systems (QMS). Recommendations for use when developing and launching innovative products
|
2012 俄罗斯标准局 |
| GOST R 56431-2015 指南标准 |
Quality management systems. Medical devices. Process validation guidance
|
2015 俄罗斯标准局 |
| GOST R 56432-2015 指南标准 |
质量管理体系. 医疗器械. 从供应商处获得的产品和服务的控制指南 Quality management system. Medical devices. Guidance on the control of products and services obtained from suppliers
Медицинское изделие |
2015 俄罗斯标准局 |
| GOST R 56853-2016 规范 |
合格评定. 管理体系审核和认证机构的要求. 第3部分. 质量管理体系审核和认证的能力要求 Conformity assessment. Requirements for bodies providing audit and certification of management systems. Part 3. Competence requirements for auditing and certification of quality management system
Аудит |
2016 俄罗斯标准局 |
| GOST R 57189-2016 指南标准 |
Quality management systems. Guidelines for the application of ISO 9001:2015
|
2016 俄罗斯标准局 |
| GOST R 57522-2017 指南标准 |
Lean Production. Guidelines for Integrated Quality Management System and Lean Production
Бережливое производство |
2017-00-00 俄罗斯标准局 |
| GOST R 58338-2018 规范 |
Quality management systems of organizations of aviation, space and defence industry. Requirements for distributors of products
|
2018 俄罗斯标准局 |
| GOST R 71923-2024 规范 |
Quality management systems for radiology and instrumental diagnostics departments
|
2025-01-24 俄罗斯标准局 |
| GOST R ISO 10018-2014 指南标准 |
Quality management. Guidelines on people involvement and competence
компетентность |
2014 俄罗斯标准局 |
| GOST R ISO 15189-2015 规范 |
Medical laboratories. Particular requirements for quality and competence
Компетентность |
2015 俄罗斯标准局 |
| GOST R ISO 15378-2014 规范 |
医疗产品用主要包装材料. 参照良好生产实践 (GMP) 的ISO 9001-2008应用的特殊要求" Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
|
2014 俄罗斯标准局 |
| GOST R ISO 29001-2023 规范 |
石油、石化和天然气工业 行业质量管理体系 对提供产品和服务的组织的要求 Petroleum, petrochemical and natural gas industries. Sector-specific quality management systems. Requirements for product and service supply organizations
|
2023-02-07 俄罗斯标准局 |
| GOST R ISO 9000-2015 术语 |
Quality management systems. Fundamentals and vocabulary
|
2015 俄罗斯标准局 |
| GOST R ISO 9001-2015 规范 |
Quality management systems. Requirements
|
2015 俄罗斯标准局 |
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