Quality
- Identifies the resources needed in the Quality Department to implement the Quality System.
- He has ultimate responsibility for ensuring that activities procedures carried out and practiced in all areas are consistent with the requirements of the Quality System and related standards.
- Prepares a quality plan, annually.
- Manages the disposition of non-conforming products.
- Responsible of inspections and testing assigns and follow-up.
- The improvement and development of existing systems and new processes and testing methods in coordination with the responsible company departments.
- Liaise with the external parties and authorities in all quality aspects.
- He is The Person Responsible for Regulatory Compliance (PRRC) is a vital part of the EO function. Euromed outlines the PRRC requirements by reference to MDRArticle 15,5 which says a manufacturer must employ a PRRC and that the PRRC role may be shared between several persons. He also notes the PRRC for the manufacturer and the AR cannot be the same person and that the PRRC for the AR must be located within the EU and that PRRC qualifications must be proven by demonstrated member state equivalency.