ISO 13485 Articles

ISO 13485 – ISO 13485 states the requirements of the quality management system for industry dealing with the design and manufacturing of medical devices.

ISO 13485:2003 – ISO 13485 2003 is a global quality standard designed for implementing the quality management system.

ISO 13485 Certification – ISO 13485 is a globally recognized quality standard which defines the requirements of the quality management.

ISO 13485 procedures – provides a set of ISO 13485 procedures which are designed to use with the ISO 13485 Quality Management.

ISO 13485 Quality Manual – A quality manual and Procedure package are the key documents of a quality management system.

ISO 13485 Training – provides ISO 13485 training package to meet the training requirement of the ISO 13485.

Avoiding FDA Warnings On Poor Management Responsibility Chains, And – Making ISO 14971 Risk Management Compliance Easier. FDA now also recognizes ISO14971, and can audit to it if manufacturer’s claim they conform to it.

ISO Standards: Why Following More (Of Them) Is Better – Lesser known, but high value ISO standards and advisories goes beyond certification in that they help you build credibility.

Winning At Customer-Required ISO Certification – New approaches and support have actually decreased the cost and time formerly associated with becoming an ISO registered company.

ISO 9001 All in One Package