Our company is currently in the process of MDSAP certification and on review of our current Quality Policy I've noticed that it talks about the QMS intending to comply with relevant ISO and international regulatory requirements and specifically lists these. For example ISO 13485, 93/42/EEC, US FDA QSR 21 CFR 820 etc. However, the ISO 13485 standard does not appear to specifically require this. Under section 5.3 Quality Policy the standard states: "b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system;". In order to comply with this clause does anyone know if companies need to list the standards and regualtions it complies with in order to meet Section 5.3 of the standard? Does the "requirements" part of this clause mean that standards and regulations should be identified?