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ISO 13485 PLUS REDLINE - Medical devices - Quality management systems - Requirements for regulatory purposes
March 1, 2016 - ISO

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations...

ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
March 1, 2016 - ISO

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations...

ASQ Q9001 - Quality management systems - Requirements
January 1, 2008 - ASQ

General This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance...

DS/ISO 18091 - Quality management systems – Guidelines for the application of ISO 9001 in local government
April 1, 2019 - DS

This International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to...

AS13100 - AESQ Quality Management System Requirements for Aero Engine Design and Production Organizations
March 1, 2021 - SAE International

This standard establishes supplemental requirements for 9100 and 9145 and applies to any organization receiving it as part of a Purchase Order or other contractual document from a customer. AS13100 also provides details of the Reference Materials (RM13xxx) developed by the SAE G-22 AESQ committee...

AAMI 13485 - Medical devices—Quality management systems—Requirements for regulatory purposes
January 1, 2016 - AAMI

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations...

CSA ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
January 1, 2016 - CSA

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations...

ASD-STAN PREN 9131 - Aerospace series - Quality Management Systems - Nonconformity Data Definition and Documentation
May 1, 2019 - ASD-STAN

Application This standard defines the common nonconformity data definition and documentation that shall be exchanged between an internal/external supplier or sub-tier supplier, and the customer when informing about a nonconformity requiring formal decision. The requirements are applicable, partly...

ISO 18091 - Quality management systems — Guidelines for the application of ISO 9001 in local government
March 1, 2019 - ISO

This International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to...

AS9131D - Aerospace Series - Quality Management Systems - Nonconformity Data Definition and Documentation
May 31, 2019 - SAE International

This standard defines the common nonconformity data definition and documentation that shall be exchanged between an internal/external supplier or sub-tier supplier, and the customer when informing about a nonconformity requiring formal decision. The requirements are applicable, partly or totally,...

DS-HANDBOG 107.2 - Quality management and quality management systems - Part 2: The "ISO 9000 family"
March 23, 2020 - DS
A description is not available for this item.
DS/EN 15224 - Quality management systems – EN ISO 9001:2015 for healthcare
January 2, 2017 - DS

This European Standard specifies requirements for a quality management system when a healthcare organization: a) needs to demonstrate its ability to consistently provide healthcare product or service that meets customer and applicable statutory and regulatory requirements, and...

ISO/IEC 80079-34 - Explosive atmospheres - Part 34: Application of quality management systems for Ex Product manufacture
August 1, 2018 - ISO

This document specifies particular requirements and information for establishing and maintaining a quality management system to manufacture Ex Products in accordance with the certificates. While it does not preclude the use of other quality management...

AENOR UNE 179008 - Quality management system for liver transplantation units
October 26, 2016 - AENOR
A description is not available for this item.
DS/ISO 29001 - Petroleum, petrochemical and natural gas industries – Sector-specific quality management systems – Requirements for product and service supply organizations
June 2, 2020 - DS

This document defines quality management system requirements for product and service supply organizations to the petroleum, petrochemical and natural gas industries. This document is written as a supplement to ISO 9001:2015. The supplementary requirements and guidance to ISO...

DS/EN ISO 9000 - Quality management systems – Fundamentals and vocabulary (ISO 9000:2015)
September 23, 2015 - DS

This International Standard describes the fundamental concepts and principles of quality management which are universally applicable to the following: - organizations seeking sustained success through the implementation of a quality management system; - customers...

DS/EN ISO 9000 ENG VER - Quality management systems – Fundamentals and vocabulary (ISO 9000:2015)
September 23, 2015 - DS

This International Standard describes the fundamental concepts and principles of quality management which are universally applicable to the following: - organizations seeking sustained success through the implementation of a quality management system; - customers...

ASD-STAN PREN 9100 - Quality Management Systems Requirements for Aviation, Space and Defence Organizations
September 1, 2016 - ASD-STAN

This standard includes EN ISO 9001:20152) quality management system requirements and specifies additional aviation, space, and defence industry requirements, definitions, and notes. It is emphasized that the requirements specified in this standard are complementary (not...

ISO 29001 - Petroleum, petrochemical and natural gas industries - Sector-specific quality management systems - Requirements for product and service supply organizations
May 1, 2020 - ISO

This International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to...

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