11 Essential Elements of A Quality Management System

Elements of Quality Management System

Although quality issues may seem insignificant, their effects on your brand reputation and relationships with customers, stakeholders, and suppliers are significant. It is therefore crucial that you prioritize quality management in your organization.  

This post will discuss the 11 steps of quality management in the business environment that will give you more confidence to achieve new excellence levels and prevent potentially dangerous mistakes. 

Related Article : What are the External Factors that affect Quality Management?

11 Essential Elements of Quality Management System

There have been countless approaches to quality management over the years. Quality management is a system that is based on concepts developed in medieval European guilds. These concepts have been refined and enhanced over the centuries. The quality management system (QMS) model has been adapted to manage eleven essential elements that constitute the framework for quality. Those elements are: 

1. Organizational Changes 

Any organization should focus on developing a culture of quality to manage changes efficiently. Whether it’s about changing policies, SOPs, processes, or facilities, there is a need for a standardized change management system that supports organizational changes without impacting ongoing operations. 

2. Employee Training and Engagement

Businesses are most successful when they have highly skilled staff members. Also, employee training, motivation, and engagement are essential components of quality management. Therefore, make sure you use a comprehensive training management system to maintain your employees’ competency for all assigned tasks. 

3. Equipment Calibration and Maintenance

Equipment in the production units must be calibrated and maintained regularly to ensure its safety. However, it can be daunting when you must manage calibration and maintenance activities manually. Therefore, it would be ideal for implementing calibration and maintenance management software to manage equipment-related activities efficiently. 

4. Inventory and Supplier Quality Management

Supplier quality management is key to ensuring consistent, high-quality raw materials and supplies. Also, inventory activities must ensure that materials and supplies are stored correctly and protected from damage. For this, you can use powerful supplier quality management software that can help streamline all your supplier-related activities, including supplier qualification, selection, onboarding, audits, and much more. 

5. Process Control

Appropriate process controls play a significant role in delivering consistent quality results. QC processes include the following in process control: 

• Assortment/Classification 
• Process Management 
• Verification of the Methods Used 
• Process Evaluation and Validation 

You can dramatically boost your internal efficiency using design control software if you struggle with process control. For validation, make sure you choose a software with digital signature capability. It will help meeting compliance as well.  

6. Documents and Records

The concept of document management is fundamentally about managing information, and these two categories overlap significantly. Documents like standard operating procedures (SOPs) create uniformity for each process. Documents should be kept up-to-date, accurate, and securely stored on a centralized platform. Identifying the right document management software should be a top priority for any company looking to grow. 

A business produces a great deal of information, including QC test results, maintenance reports, and more. Therefore, they must ensure that all the information can only be accessed by those with the appropriate privileges, such as quality managers. For this, you can easily find cloud-based document management solutions that come with role-based access. 

7. Nonconformance Management

“Nonconformance” means anything that goes wrong or is not conforming to the specified requirements. These issues can be detected by QMS software and investigated to determine the root cause and prevent recurrences. Alternatively, you can integrate a nonconformance management software with your existing QMS to identify, record, and manage defects and deviations. A software will also help you categorize quality based on their risk severity and rate of occurrence so you can focus on the major, moderate, and low level risks accordingly.  

8. Risk Assessment

An assessment of risk involves comparing process performance to internal or external metrics, such as industry benchmarks. A quality manager, an internal auditor, or an external inspector typically conducts assessments. It will help if you will utilize CAPA management software for streamlining risk assessment and management processes. A robust software will also help your quality teams take a proactive approach towards quality issues to prevent catastrophic results. 

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9. Audits & Process Improvement

A quality management system should continually improve business processes. An effective QMS will include QC as well as CAPA (occurrence management). Furthermore, we recommend that you invest in audit management software to recognize and automate significant improvements to internal processes. The right audit management software will help you quickly analyze the quality trends to make informed business decisions while eliminating all the inconsistencies from your quality system. It also drives continuous improvements. 

10. Excellent Customer Service

The goal of every business is to offer excellent customer service. Therefore, the quality management software should maximize customer satisfaction by consistently delivering high-quality products and other services. In addition, businesses should understand their customers’ needs and use feedback/complaints from them to improve. So, it would be best to use a complaints management system to track customer complaints and respond to them in time. 

11. Facilities and Safety

An organization’s safety, security, and cleanliness depend on well-defined procedures and standards. It includes physical security, safety procedures, and ergonomics. An organization must have a well-defined set of policies in place covering all the aspects of security and hygiene. A suitable quality management software can help you create and circulate all the quality related documents across the organization efficiently. It further ensures that all your quality teams are on the same page, regardless of their geographical locations. 

The Role of Software in Quality Management

According to ISO, quality management is the coordination of activities that a company undertakes to control and direct quality. 

A QMS must include all 11 critical elements for consistently high-quality operations and ensure that these elements work together. If your QMS lacks several aspects, such as document control or physical security, it can easily collapse. A QMS that complies with all the basics but fails to coordinate between them by considering quality trends or root causes will put your business at risk. 

Creating and maintaining a QMS is easier because ISO standards don’t require software. But a paper-based quality process can be challenging to maintain because of poor visibility and human intervention. Rather than building a QMS from scratch, you can use software to reduce the amount of work needed. 

Utilizing the right quality management software can save you money, efforts, and time to invest in core-business activities by streamlining and standardizing your core processes. Furthermore, you can create a closed loop quality system to manage things more effectively and efficiently. 

With Qualityze’s cloud based QMS, businesses can ensure their quality management processes meet ISO and FDA guidelines. In it, you will find all the essentials for creating solid quality baselines for all kinds of businesses- Big, Small, or Medium.  

Qualityze EQMS is built on the most powerful and secure platform, i.e., Salesforce.com to ensure maximum flexibility, security, and scalability to manage your quality processes. It comes with amazing in-built capabilities such as Reports, Dashboards, Audit Trails, Digital Signature, Chatter, and much more. Check out more about our solution here. 

Related Article: A Guide to Measuring Effectiveness of Quality Management Processes

Alternatively, you can get in touch with our customer success team on 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you.