11 Essential Elements of A 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. 

Quality Management System: 11 Essential Elements 

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. 

Related Articles: Risk Assessment Vs Risk Management: How Are they Different?

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. 

Alternatively, you can get in touch with our customer success team on 1-877-207-8616 or write to us at [email protected], and we will be right there for you.