Quality Management System - QMS Software
QMS (Quality Management System) Software
A sound quality management system (QMS Software) aims to help coordinate and align an organization’s activities to uphold the customer and regulatory requirements while focusing on improving the effectiveness and efficiency on a continuous basis. While the concept of quality management is not new, there are several concerns over how beneficial QMS is to the company and the steps involved in implementing the software. Read the blog to learn more about QMS and the world around it
What is a Quality Management System (QMS)
QMS focuses on addressing the complex product development lifecycle. It is designed for various highly regulated industries such as pharmaceutical, biotech, and medical devices products. A sound QMS evaluates the set of policies, processes, and procedures of a company. Using this evaluation, organizations can improve the core business areas of the company such as production, development, and service. Simply put, QMS can help :
- Meet customer requirements
- Improve customer satisfaction
- Company’s internal processes
- Enhance the use of resources
- Internal communication
- Prevent product defects
Concept of quality management
Quality management is centered around the idea of improving customer satisfaction and loyalty as well as to meet regulatory requirements. A company can maintain the desired level of product or service excellence by prioritizing quality. The concept of quality has four different components, namely
- Determination of quality policy
- Creating and implementing quality planning and assurance
- Quality control
- Quality improvement
Principles of quality management
There are 7 quality management principles to focus on as an organization
- Customer focus
- Leadership
- People engagement
- Process-based approach
- Improvements
- Evidence-based decision making
- Relationship management
Importance of QMS: how CQ QMS software helps
product innovation-
speed to market and operational excellence
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meet regulatory requirements
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improve customer satisfaction
A next-generation, integrated quality management system solution, CQ QMS accelerates product innovation with a steadfast focus on driving continuous improvement across the organization.
Implementing a QMS
Implementing a QMS requires a lot of procedures and documentation. In order to successfully implement QMS in an organization, follow these steps
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Measure
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Control
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Deploy
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Design
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Review and improve
Benefits of QMS
By implementing an automated QMS solution, businesses can experience the following benefits:
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Reduction in major product recalls
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Improvement in supplier visibility
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Increased operating margins
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Significant decrease in business challenges
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Internal and external capabilities growth
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Creates a culture of quality
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Improve compliance
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Helps achieve organizational goals
Benefits of QMS
By implementing an automated QMS solution, businesses can experience the following benefits:
- Reduction in major product recalls
- Improvement in supplier visibility
- Increased operating margins
- Significant decrease in business challenges
- Internal and external capabilities growth
- Creates a culture of quality
- Improve compliance
- Helps achieve organizational goals
Requirements to implement a QMS
In order to implement QMS, here is a list of requirements that needs to be in place.
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Clearly documented quality policy and objectives
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A quality manual that details scope, justified exclusions, documented procedures, checklists, guidelines
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Mandated compliance standards
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Company documents that effectively details plan, operate, monitor, and control
Frequently Asked Questions
How to automate a quality management system?
What are the areas where quality management is applicable?
QMS is applied across different areas of function within the organization, including quality, manufacturing, engineering, operations, management, and suppliers. While implementing QMS, it is important to follow the seven key processes:
- Nonconformance / Deviations / OOS
- CAPA
- Equipment
- Inspections
- Workforce Digitalization
- Risk and Compliance
- Supplier Management
What are the regulations and challenges in QMS?
To build an effective risk and quality compliance system, it is important to follow the management standards like ISO 9001 among others. The standard is applicable across industries. The latest update namely ISO 9001:2015 is focused across functions from documentation to managing processes with a risk-based thinking approach. This new standard emphasizes further the importance of formal risk analysis to identify management challenges in business processes.
Related Insights
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