Comparative Analysis of ISO 13485 and QMS Requirements Among GHWP Member Economies

The document provides an objective comparison of ISO 13485 and Quality Management System (QMS) requirements across 33 GHWP member economies. These economies are categorized into three groups:

• No QMS requirements
• Direct use of ISO 13485
• Use of Good Manufacturing Practice (GMP) and equivalent regulations

Key features include:

• Clause-by-Clause Analysis: Detailed examination of the requirements.
• Comparison Table: Visual representation of differences.

Note: The document does not evaluate the advantages or disadvantages of the laws and regulations.

Source:http://www.ahwp.info/sites/default/files/Proposed%20Document-Comparison%20study%20of%20new%20ISO13485%20vs.%20QMS%20requirements%20in%20GHWP%20member%20economies.pdf

Region:  All Markets