Other Related Quality Standards
These standards are more specialised, they are mentioned for informational purpose only
ISO 10019:2005
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Guidelines for the selection of quality management system consultants and use of their services
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| Abstract : |
ISO 10019:2005 provides guidance for the selection of quality management system consultants and the use of their services.
It is intended to assist organizations when selecting a quality management system consultant. It gives guidance on the process for evaluating the competence of a quality management system consultant and provides confidence that the organization's needs and expectations for the consultant's services will be met. |
Specialised Standards
| ISO⁄TR 13352:1997 |
Guidelines for interpretation of ISO 9000 series for application within the iron ore industry
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| Abstract : |
No abstract available
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| ISO 13485:2003 |
Medical devices -- Quality management systems -- Requirements for regulatory purposes
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| Abstract : |
ISO 13485:2003 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 requirements and regulatory requirements applicable to medical devices and related services.
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| ISO⁄TR 14969:2004 |
Medical devices -- Quality mangement systems -- Guidance on the application of ISO 13485: 2003
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| Abstract : |
ISO⁄TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.
This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.
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| ISO 15161:2001 |
Guidelines on the application of ISO 9001:2000 for the food and drink industry
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| Abstract : |
No abstract available
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| ISO 15189:2003 |
Medical laboratories -- Particular requirements for quality and competence
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| Abstract : |
ISO 15189:2003 specifies requirements for quality and competence particular to medical laboratories.
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| ISO⁄TS 16949:2002 |
Quality management systems -- Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations
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| Abstract : |
This Technical Specification, in conjunction with ISO 9001:2000, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products.
This Technical Specification is applicable to sites of the organization where customer-specified parts, for production and⁄or service, are manufactured.
Supporting functions, whether on-site or remote (such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand-alone certification to this Technical Specification.
This Technical Specification can be applied throughout the automotive supply chain.
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| ISO⁄IEC 90003:2004 |
Software engineering -- Guidelines for the application of ISO 9001:2000 to computer software |
| Abstract : |
ISO⁄IEC 90003:2004 provides guidance for organizations in the application of ISO 9001:2000 to the acquisition, supply, development, operation and maintenance of computer software and related support services. ISO⁄IEC 90003:2004 does not add to or otherwise change the requirements of ISO 9001:2000.
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