QMS Framework is responsible for defining the quality standards inlining with regulatory standards to ensure for consistent supply of quality medicine to the patients. Basically QMS framework design per ISO 9001:2015 standards and follow structured hierarchy - There will be three levels - Level 1- Strategic level - Policy, Manual and module - documents in this level can't be presented to HA inspections Level 2 and Level 3- Operational level - documents in this level can be presented to HA inspections Level 2- procedures, batch records, protocol etc Level 3- Record and reports Understanding and identifying “interested parties” is one of the foundational requirements of ISO 9001:2015, as outlined in Clause 4.2. Yet many organizations struggle with this task — not because it is difficult, but because it often feels vague or disconnected from day-to-day operations. In practice, identifying interested parties is understanding who affects or is affected by your quality management ...