Quality Management Systems Standards
ISO9001:2000
The primary focus of this standard is to address customer satisfaction through the use and continual improvement focused on the entire organization’s quality plan and objectives. A process approach, where the interrelationships of activities are established and understood
ISO/IEC 17025:1999 (Accreditation QMS)
Designed for the testing and calibration laboratories with emphasis toward the competency of the results and personnel. Accreditation system that is aligned with the QMS ISO9001:1994
ISO/IEC 17025:2005 (Accreditation QMS)
Upgrade and aligned to ISO9000:2000 which is process based QMS
ISO 13485:2003
Is based on ISO9001:2000 with some modifications specifically for the medical devices, especially related to regulatory requirements.
ISO 14969:2004
Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003
ISO 15189:2003 (Accreditation QMS)
Medical laboratories - Particular requirements is for quality and competence of medical environments. The first part of ISO 15189 is completely based on the ISO 9001: 2000 requirements. The second part - Technical requirements: specific requirements related to activities carried out by clinical laboratories.
ISO/TS 16949:2002
The updated version of ISO/TS 16949 integrates the ISO 9001:2000 requirements with the automotive industries specific requirements. This standard is replacing QS-9000 Standard by December 2006.
AS9100 Revision B
AS9100 is based on ISO9001 standard that has 89 additional requirements that are specific to the needs of the Aerospace industry
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