Quality Management System

WHAT IS A QUALITY MANAGEMENT SYSTEM?

A quality management system (QMS) is a formalized system that defines and documents an organization’s processes, procedures, and responsibilities for achieving quality policies, practices, and objectives. It helps an organization coordinate and direct its activities to meet customer and regulatory requirements, as well as continuously improve its effectiveness and efficiency.

WHAT ARE THE BENEFITS OF A QMS?

Implementing a QMS affects every aspect of an organization's performance. Benefits of a documented QMS include:

• Meeting customer requirements, which helps instill confidence in the organization, in turn leading to more customers, sales, and repeat business
• Meeting the organization's requirements, which ensures compliance with applicable regulations and provides products and services in the most cost and resource-efficient manner, creating room for expansion, growth, and profit

These benefits offer additional advantages, including:

• Defining, improving, and controlling processes
• Reducing waste
• Preventing mistakes
• Lowering costs
• Facilitating and identifying training opportunities
• Engaging staff
• Setting organization wide direction
• Communicating a readiness to produce consistent results

WHAT ARE SOME QMS FRAMEWORKS?

Several frameworks exist to guide QMS development, including

• ISO 9001
• ISO 9000 series
• ISO 14000 series (environmental management systems)
• ISO 13485 (quality management systems for medical devices)
• ISO 19011 (auditing management systems)
• IATF 16949 (quality management systems for automotive-related products)
• AS 9100 (quality management systems for aviation, space, and defense)

Furthermore, several industries also have developed standards, built upon ISO 9001, that offer specific direction regarding additional expectations that are uniquely associated with their operations.

ISO 9001 is the most recognized and implemented quality management system standard in the world. ISO 9001 specifies the requirements for a QMS that organizations can use to develop their own programs.

The standard is structured around seven quality management principles. Quality management principles are the guiding beliefs that, when used for organizational decision-making, ensure long-term success from the perspective of customers, employees, and other stakeholders. The quality management principles demonstrate the depth of the organization’s commitment to quality. Well-formulated principles should be timeless, not dependent on temporary circumstances.

The ISO 9001:2015 principles are:

1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Continuous improvement
6. Evidence-based decision making
7. Relationship management

WHAT ARE THE ELEMENTS AND REQUIREMENTS OF A QMS?

Each element of a QMS helps achieve the overall goal of meeting customer and organizational requirements. A QMS should address an organization’s unique needs, but many of the QMS systems have common expectations, including:

• Leadership
• Planning, commitment, and review
• The system spans the breadth of the organization
• Metrics and feedback
• Communication, education, and training
• Risk management
• Teamwork
• Compliance to requirements
• Continuous improvement

HOW DO YOU ESTABLISH AND IMPLEMENT A QMS?

Every organization has its own culture, which influences which QMS methods are most efficient and effective. Instead of developing a QMS by addressing each expectation described in a selected model, organizations should outline the approaches currently in use for managing quality and meeting customer expectations.

A basic model for gathering customer expectations can be structured in the following four steps: plan your customer data system, gather customer data, understand the data, and deploy (make use of) the data.

Next, map those approaches against the appropriate QMS framework or model. For each identified gap, the organization should determine whether it would benefit from addressing the opportunity, and must clearly understand the potential benefit before implementing any changes.

The QMS design should be influenced by the organization’s objectives, needs, products, and services. This structure is based largely on the plan-do-check-act cycle and allows for continuous improvement to the product and QMS.

The basic steps to implementing a QMS are:

1. Design
2. Build
3. Deploy
4. Control
5. Measure
6. Review
7. Improve

Design and build

The design and build steps develop the QMS’s structure, processes, and implementation plans. Top management should oversee these steps to ensure the needs of the organization and its customers are a driving force behind the system’s development.

Deploy

Deployment is best served granularly by breaking down each process into subprocesses and educating staff on documentation, education, training tools, and metrics. Organizational intranets are increasingly being used to help deploy QMSs.

Control and measure

The realization of these two areas is accomplished largely through implementing routine, systematic audits of the QMS. The specifics vary from organization to organization, depending on size, potential risk, and environmental impact.

Review and improve

These steps detail how the audit results are handled. The goals are to determine the effectiveness and efficiency of each process toward its objectives, communicate these findings to the employees, and develop the best new practices and processes based on the data collected during the audits.

The improvement loop, shown below, indicates how a QMS provides the necessary pathways for organizations to implement quality objectives via quality policies and procedures. Opportunities for improvement are identified via quality audits, and applicable corrective and preventive actions are developed and implemented. Proper data analysis helps steer improvement efforts. The overall effectiveness of the improvement loop is discussed in management reviews.

QMS development, establishment, implementation, and monitoring should be accomplished under the approach of applying the Juran Trilogy. The Juran Trilogy focuses on the three critical processes of quality management—namely quality planning, quality control, and quality improvement. By taking this approach, organizations can maximize their potential to operate in the most strategic, efficient, and effective manner possible.