A Quality Management System (QMS) is defined as a system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
QMS is the core of the quality and compliance process for any organization. It helps in the reduction of audit time and findings, it also helps in product recalls.
A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. It serves many purposes, including:
- Improving processes, product and system
- Reducing waste, and human error
- Lowering costs
- Facilitating and identifying training opportunities
- Engaging staff
- Reduces training time of new employee
- Setting an organization-wide direction.
Pharmaceutical organisation can achieve the highest level of confidence in its customer and regulators by following ISO 9000 and ICH Q10 guidelines.
The QMS design should be made by the organization depending upon its varying objectives, needs, and products and services provided. This structure is based largely on the Plan – Do – Check – Act cycle and allows for continuous improvement to both the product and the QMS.
Elements and Requirements of A Quality Management System:
Each element of the QMS helps in achieving organizations requirement and meeting customer’s needs. The elements all systems have in common include:
- The organization’s quality policy and quality objectives
- Quality manual
- Procedures, instructions, and records
- Data management
- Internal processes
- Customer satisfaction from product quality
- Improvement opportunities
- Quality analysis.