ISO 9001:2015 is mainly developed based on set of standardize quality system and best practices require to be follow each and every organization. Try to understand quality is a one of the most valuable customer requirement and organization is to fulfil with desirable accuracy. The main objective of quality management system is to fulfil customer requirements. ISO 9001:2015 is a standard to fulfil each and every organization for manufacture or service a product. In this article we will try to understand what are the key important elements required for maintaining quality management system.
Important 5 key elements of QMS
1. Leadership and commitment
Letās understood quality management system is basically top ā down approach. Its start building with top management, decide QMS policy, goals, objectives and standardize quality processes that everyone must be followed. When we talk about organizational leadership, leader mainly involved in three things as per mention below.
- Structural quality management system development.
- Communicate importance of QMS in everyone involve with organization.
- Provide necessary resources of QMS.
- Organization is able to take task from customers and give commitment for product quality as per customer requirement. Here, customer satisfaction is a key objective.
2. Process approach
Process approach is basically maintaining process quality as per quality management standard. Mainly focused on few things for maintaining process quality as per below.
- Quality process is well defined & documented.
- Process must be performed as per manufacturing quality plan.
- Measurement system follow the standards.
- Ensure to use calibrated measuring instruments.
3. Customer Focused
Try to understand the main goal of running business is to providing services to customer with fulfil customer needs and expectations. Developed structural system for capturing customer feedback for quality point of view. Maintain standard practices for taking corrective and preventive action of defects and satisfy customer needs.
3. Continuous Improvement
Many of the organization myth is continuous improvement is a one-time process, No itās a part of your routine practices for betterment of quality management system. For improving current QMS performance, performance monitoring and tracking is necessary. Developed a failure mode effect analysis of process and take preventive action to improve quality management system.
4. Employee Involvement
Employee involvement is very essential. Information flow must be fully pass from top-down and bottom-up approach. Ensure each employee must be involving in improvement activity. Plan training & awareness session and structurally developed reward and recognition system for quality improvements.
5. Supplier Management
Quality management system involved selecting, managing and evaluating suppliers as per quality management standards. Mainly ensure supplier meets organizational quality requirements or not.
Practical Implementation steps for Quality Management System.
- Define and document processes.
- Identify roles and responsibilities of each processes.
- Train employees as per QMS standards.
- Implement quality processes as per planed.
- Monitor and measure quality processes.
- Analyze and improve quality processes.
- Conduct internal audit for variation analysis.
- Management review ā audit performance.
- Continuous improvement.
Interested
i need QMS papers or journals written on assessment of quality in pharmaceuticals manufacturing . please share me on my mail jenberug@gmail.com for further reading and experiences of research paper for future!
Dear Sir,
I am doing internship in the IBN SINA Pharmaceuticals Industry PLC which is a renowned pharmaceutical company in Bangladesh. I am writing QMS and also overall operation management Journals and assessment reports. Please wait for a awhile for the output.
Thank you.
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