In the increasingly competitive business environment, the quality of products/services is a crucial factor determining the success of a company. The Quality Management System (QMS) is an effective tool that helps businesses enhance the quality of their products/services, meet customer requirements, and strengthen competitiveness. To delve deeper into what QMS is and the benefits it brings, let’s explore together in the following article with GOL!

What is QMS?

QMS – Quality Management System is a system consisting of processes, procedures, and responsibilities designed to achieve quality policies and objectives within an organizational or business framework.

The Quality Management System according to ISO 9001 standards is a set of internationally recognized requirements aimed at establishing rules, policies, processes, and procedures to provide products and services that meet customer needs and improve customer satisfaction. The Quality Management System standard is maintained by the International Organization for Standardization (ISO), and the majority of member countries within this organization agree that this standard can be internationally recognized and accepted as the gold standard for processes used worldwide for QMS.

• The Quality Management System serves various purposes, including:
• Process improvement
• Waste reduction
• Cost reduction
• Creating conditions and identifying training opportunities
• Attracting employees
• Establishing a development direction for the business.

Classification of QMS

QMS can be classified based on various criteria, including:

Classification based on content

• Quality Management System according to the International Organization for Standardization (ISO) 9000 standards
• Total Quality Management (TQM) – a comprehensive quality management system
• Q–Base Quality Management System for small and medium-sized enterprises
• Standard systems ensuring food quality and safety: GMP, HACCP, SQF, ISO 22000
• Quality management system for automotive manufacturing and assembly: QS 9000
• IATF 16949 Automotive Quality Management System
• Quality management system based on meeting criteria for quality awards
• ISO 13485 Quality Management System for Medical Devices
• Some other standards related to quality management issues: ISO 14001, SA8000, OHSAS 18000, ISO 26000, Information Security Management System ISO/IEC 27000

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Classification based on the level of management

Quality management system at the national level

Quality management systems of organizations, including businesses

Principles in Quality Management System

Customer Focus

Customer focus is the first principle among the 7 quality management principles. It encompasses both customer needs and customer service. This principle emphasizes that a business should understand its customers, what they need, and when they need it. While striving to meet, but ideally exceed, customer expectations.

The customer focus principle is much more comprehensive and overarching, including:

• Understanding current and future customer needs.
• Aligning organizational objectives with customer needs and expectations.
• Meeting customer requirements.
• Measuring customer satisfaction.
• Managing customer relationships.

Read more: FSSC 22000 – Food Safety System Certification Scheme

Leadership

Principle 2, focusing on organizational leadership, emphasizes that businesses should have clear and specific goals, ensuring active participation from their employees in achieving those objectives. Leadership plays an irreplaceable role in the success of an organization, with the provision of direction and goals being critically important.

Effective leadership involves several indispensable roles, making the establishment of direction and goals paramount to success.

People Engagement

Every member of an organization contributes to its success, and the same applies to quality. Quality is no longer the sole responsibility of the quality department; instead, it becomes the responsibility of every member within the organization.

3.4 Process Approach

An electronic quality management system (EQMS) encompasses a diverse range of interconnected processes aimed at generating consistent and foreseeable outcomes. When all stakeholders possess a profound comprehension of how the QMS yields results, it becomes possible to enhance focus on improvement opportunities, optimize cross-functional performance, and instill confidence in partners regarding the consistent delivery of quality.

• Clearly articulate objectives and establish formal procedures to attain them.
• Comprehend interdependencies among processes and evaluate the repercussions of any alterations.
• Proactively address risks to enhance the overall effectiveness of quality management.
• Engage everyone in defining and comprehending your processes, involving not only internal teams but also external parties like suppliers.

Continuous Improvement

Risk-based thinking and quality management are ongoing processes. Successful organizations prioritize continuous improvement to streamline root-cause investigations, foster innovation, and enhance the capability to anticipate and respond to both internal and external opportunities.

• Educate and train employees at all levels to utilize fundamental quality management tools and methodologies.
• Integrate improvement considerations into the development of new products.
• Implement specific processes to execute improvement projects throughout your organization.
• Evaluate the outcomes, including employee training, process enhancements, and quality levels.

Evidence-Based Decision Making

This principle is quite straightforward: continuous improvement should be a positive business goal. The benefits of this are evident: increased ability to seize new opportunities, organizational flexibility, and enhanced performance.

Relationship Management

Quality management extends beyond internal operations to encompass the management of relationships with external partners such as suppliers. Effectively managing partner relationships enhances your ability to deliver value to customers, supports an efficient supply chain, and improves the overall performance of your organization.

• Map out all relevant relationships with suppliers, partners, customers, and investors.
• Define Key Performance Indicators (KPIs) and goals for each relationship.
• Prioritize relationship management based on quality impact.
• Measure the performance of each relationship and provide feedback to partners.

Benefits of quality management system

Implementing a quality management system like ISO 9001 offers numerous benefits to business owners. It typically boosts efficiency and productivity, providing a competitive advantage over competitors.

Below are some of the business benefits to consider:

Advantages of ISO 9001:

• Ensures consistent, high-quality products and services for customers, potentially leading to new business opportunities.
• Increases efficiency and reduces waste.
• Provides better and consistent control of major business processes.
• Enhances understanding of customer needs.
• Regulates successful working practices.
• Improves risk management.
• Boosts customer satisfaction.
• Increases employee participation.
• Facilitates better internal communication.
• Ensures greater consistency in product and service quality.
• Sets your business apart from competitors.
• Drives increased profits.
• Reduces costly errors.
• Exploits new markets, both domestically and internationally.
• Helps manage growth effectively.
• Cultivates an embedded culture of quality.

Obtaining ISO 9001 certification is a globally recognized achievement, potentially enhancing your international reputation and expanding business opportunities abroad.

Benefits of ISO 9004:2018 to Your Business

The ISO 9004 standard emphasizes the quality of the organization itself, rather than solely focusing on the quality management of products and services as outlined in ISO 9001.

This standard provides recommendations for achieving long-term, sustained success by concentrating on meeting the needs and expectations of all relevant interested parties, not just customers.

ISO 9004 is applicable to organizations of any size, type, and activity. Its latest revision includes an enhanced self-assessment tool that can assist you in:

• Assessing the maturity level of different components within your system.
• Identifying and prioritizing potential areas for improvement.

It’s important to note that ISO 9004 is intended for guidance purposes only. It is not designed for certification, regulatory, or contractual use. Read more about the ISO 9004:2018 standard for further information.

Disadvantages of ISO Implementation

Despite the numerous benefits, implementing ISO standards may pose certain challenges, including:

1. Cost: Obtaining and maintaining certification, particularly for ISO 9001, can be costly.
2. Time: Implementing ISO standards requires a significant investment of time.
3. Resistance to Change: Some employees within the organization may resist changes associated with ISO implementation.

While you can tailor the standard to fit your business needs and resources, you may require the assistance of a consultant, which can incur additional costs.

Certification to ISO 9001 is not obligatory, but in certain cases, it may be a requirement for working with specific clients such as public bodies. It’s essential to carefully evaluate whether certification is appropriate for your business. Many organizations derive benefits from using the standard without necessarily pursuing formal certification.

Benefits of Implementing QMS

Many benefits result from the development and implementation of a robust Quality Management System (QMS). Some of the most apparent advantages of implementing QMS are as follows:

Enhanced Product and Process Quality Management:

• Quality management of products and processes enables an organization to consistently meet the needs and desires of customers. Increased customer satisfaction leads to higher sales, expanded market share, and brand development.

Cost Reduction through Process Control:

• Minimizing costs related to rework and waste is achieved through the implementation and monitoring of process control measures. This ensures efficient use of resources and reduces the likelihood of defects, contributing to overall cost savings.

Data-Driven Decision Making:

• Management can make informed decisions based on data rather than speculation. Data collected through internal assessments and other methods allows leadership to make decisions supported by evidence. Valuable resources are strategically utilized to have the greatest impact on process improvement and quality issue reduction.

Continuous Improvement Culture:

• Involvement of colleagues in process and product improvement efforts helps foster a culture of continuous improvement within the organization. Introducing methodologies such as Kaizen, 5S, and other quality tools empowers team members to take ownership of processes gradually.

Compliance with Regulations and Legal Requirements:

• Ensuring that all regulations and legal requirements are met with each new product introduction allows for global product marketing. This adherence guarantees that products are introduced in compliance with all necessary standards, facilitating international marketing.
• The implementation of a strong QMS not only ensures compliance but also contributes to organizational efficiency, customer satisfaction, and a culture of continual improvement.

The requirements in the Quality Management System (QMS)

Each element of the Quality Management System contributes to achieving common objectives, which involve meeting the requirements of both customers and the organization. These elements include:

• Quality policy and quality objectives of the organization.
• Quality manual.
• Procedures, instructions, and records.
• Data management.
• Internal evaluation processes.
• Customer satisfaction derived from product quality.
• Opportunities for improvement.
• Quality analysis.

Establishing and implementing QMS

Before establishing a quality management system, your organization must identify and manage multifunctional processes, interconnected in various ways, to ensure customer satisfaction. The design of the QMS should be influenced by the goals and diverse needs of the organization, as well as the products and services provided. This structure largely relies on the Plan-Do-Check-Act (PDCA) cycle, enabling continuous improvement for both products and the QMS. The fundamental steps to implement a quality management system are as follows:

• Design
• Build
• Deploy
• Control
• Measure
• Review
• Improve

Design and Build

The design and build phases are instrumental in developing the structure of the QMS, its processes, and implementation plans. Senior management should oversee this phase to ensure that the organization’s needs and customer requirements drive the system’s development.

Deployment

Deployment is best served in a detailed manner by breaking down each process into sub-processes and providing employees with documentation, education, training tools, and data guidance. The company’s internal network is increasingly utilized to support the deployment of quality management systems.

Control and Measurement

Control and measurement are two areas in establishing QMS primarily carried out through regular, systematic assessments of the quality management system. Specific details vary significantly between organizations depending on scale, inherent risks, and environmental impacts.

Evaluation and Improvement

Evaluation and improvement entail a detailed examination of how audit results are handled. The objective is to determine the effectiveness and efficiency of each process in achieving its goals, communicate these findings to staff, and develop new best practices and procedures based on data collected during the evaluation process.

The most prevalent Quality Management System

• ISO 9001

ISO 9001 is the first standard issued by the International Organization for Standardization (ISO) and is applied to assess the Quality Management System (QMS) of organizations and businesses, irrespective of their field of operation, scale, or type of business.

• ISO 14001: Environmental Management System

ISO 14000 is a set of standards related to environmental management designed to assist organizations in minimizing adverse impacts on the environment, ensuring compliance with environmental laws, regulations, and other environmental policies.

• ISO 17025: Quality Management System for Laboratories

ISO/IEC 17025 is the most widely used ISO standard by testing and calibration laboratories today. In most countries, it is the standard that nearly all laboratories must undergo accreditation to be considered technically competent. In many cases, suppliers and regulatory bodies will not accept test or calibration results from laboratories that are not recognized or accredited.

• IATF 16949: Quality Management System for the Automotive Industry

The ISO/TC 16949 standard aims to develop a quality management system for continuous improvement, with a focus on preventing errors and reducing variation, waste, in the supply chain, and assembly processes in the automotive industry. In October 2016, ISO/TS 16949 was officially replaced by IATF 16949.

• Forest Stewardship Council (FSC) Quality Management System
• Q-Base Quality Management System

We hope that the information provided here has helped you gain a better understanding of QMS. If you have any further questions, please feel free to contact GOL for free consultation and support!

Reference:

According to American Society for Quality (ASQ) – WHAT IS A QUALITY MANAGEMENT SYSTEM (QMS)?

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