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ISO 13485 Standard (Medical Device)
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 products.
Draft Document - Quality management systems Proposed changes to the requirements of ISO/DIS 9001:2007
ISO 9001:2000 Standard Document Number: ISO 9001
International Organization for Standardization
Replaces and incorporates ISO 9001, ISO 9002, & ISO 9003.
This single certifiable Standard now applies to all organizations regardless of size, industry, product or service. It's more flexible than its predecessors, and has an emphasis on customer satisfaction, continual improvement and efficiency. Organizations currently certified to ISO 9002 or 9003 will work to this new Standard.
ISO 9004
Quality management systems - Guidelines for performance improvements (ISO 9004:2000); Trilingual version EN ISO 9004:2000
DIN-adopted European-adopted ISO Standard
ISO 14000 Standard (environmental)
Environmental management systems - Requirements with guidance for use
Edition: 2nd
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