ISO 9001 - Quality Management

ISO 9001 provides a generic yet comprehensive structure on which organisations can establish processes to help achieve business objectives. It has received widespread global recognition with around one million certificates issued.

ISO 9001 compliant business management systems have been adopted across all industry types, from manufacturing through to professional service organisations. This level of acceptance is a reflection of the flexibility and proven practical value it offers to a wide variety of businesses.

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ISO 13485 - Medical Devices - Quality Management Systems

ISO 13485:2016 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.

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EN 15224 - Health Care Services - Quality Management Systems

This European standard specifies requirements for a quality management system where an organization: a) needs to demonstrate its ability to consistently provide health care services that meet requirements from customers as well as applicable statutory and regulatory requirements, and professional standards b) aims to enhance customer satisfaction through the effective application of the system, including continual improvement of the management system, the clinical processes and the assurance of conformity to requirements related to the quality characteristics. 

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ISO 15378 - Primary packaging materials for medicinal products

Particular requirements for the application of ISO 9001, with reference to good manufacturing practice (GMP)

ISO 15378 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 enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. 

All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

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ISO 7101 - Healthcare organization management

Management systems for quality in healthcare organizations.

The first international consensus standard for healthcare quality management. It prescribes requirements for a systematic approach to sustainable, high quality health systems, for organizations of any scale, structure, or region

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ISO 21001 - Educational Organizations

ISO 21001 specifies requirements for a management system for educational organizations (EOMS) when such an organization: a) needs to demonstrate its ability to support the acquisition and development of competence through teaching, learning or research; b) aims to enhance satisfaction of learners, other beneficiaries and staff through the effective application of its EOMS, including processes for improvement of the system and assurance of conformity to the requirements of learners and other beneficiaries.

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ISO 29001 - Petroleum, petrochemical and natural gas industries - Quality Management System

ISO 29001 defines the quality management system for product and service supply organizations for the petroleum, petrochemical and natural gas industries.

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EN ISO 3834-2 - Quality requirements for fusion welding of metallic materials

ISO 3834-2:2005 defines comprehensive quality requirements for fusion welding of metallic materials both in workshops and at field installation sites.

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ISO 19443 - Supply chain of the nuclear energy sector - Quality Management System

Specific requirements for the application of ISO 9001:2015 by organizations in supply chain of the nuclear energy sector supplying products and services important to nuclear safety (ITNS).

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, andb) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

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ISO/TS 54001 - Electoral Organizations - Quality Management Systems

Particular requirements for the application of ISO 9001:2015 for electoral organizations at all levels of government.

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 enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

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