The new ICH Guideline Q10 has combined different guides for Quality Systems into one document.
This guideline was developed based on the following documents to achieve a global harmonization for the requirements of a modern quality system.
ISO 9000: "Quality Management Systems"
ISO 9001: 2000: "Quality Management Systems"
ISO 9004: "Quality Management Systems"
Eudralex Volume 4: "Medicinal Product for Human and Veterinary Use: Good Manufacturing Practice"
ICH Q7a: "Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients"
US FDA: "Draft Guidance for Industry Concerning Quality Systems Approach to Pharmaceutical current Good Manufacturing Practice Regulations"
ISO 13485: 2003 Medical devices -- Quality management systems
You can read the full guideline on the ICH web page by "clicking here"