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Document management

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 system (QMS), what their expectations are, and how those expectations can influence your ability to deliver consistent quality. When done well, this process drives strategic awareness, strengthens stakeholder relationships, and builds a more resilient business.

Why Interested Parties Matter in ISO 9001

Identifying interested parties isn’t just a box to check — it has direct and strategic value.

Alignment with Strategic Direction

Understanding external and internal stakeholder needs supports business alignment, helping leadership ensure the QMS contributes to long-term goals.

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