INTRODUCTION TO QUALITY MANAGEMENT SYSTEM (QMS)

Before hitting the Quality Management System as a whole, let's first understand the concept of associated terms; Quality, Management & System.

Quality: In simple words, Quality referrers to all those features of a product or service which are required by the customer.

Management:  Management is a process of administering and controlling the affairs of the organization. It applies a set of principles to achieve organizational goals.

System: System is a set of defined policies or procedures according to which something is done in an organized way.

Now, Quality Management System may be defined as a set of coordinated activities to direct and control an organization in order to continually improve the effectiveness and efficiency of its performance. It comprises of collective policies, plans, practices and the supporting infrastructure by which an organization aims to reduce and eventually eliminate non-conformance to specifications, standards and customer expectations in the most cost effective and efficient manner.

In other words we can say that Quality Management System is integration of business processes; their effective planning and execution to ensure customer satisfaction. QMS is conveyed through organizational goals, set of policies, objectives, procedure and resources needed to implement it.

ISO 9001 (Latest version 9001:2015) international standard specifying requirements of Quality Management System is most recognized and implemented quality management system standard in the world.

Some of the other recognized Quality Management standards that are specific for certain industries are:

• AS9100: Quality Management System standard for aerospace industry
• ISO 13485: Quality Management System standard for medical devices industry
• IATF 16949: Quality Management System standard for automotive industry

      Functions of quality management system:

Quality Management System helps to:

• Identify issues related to legal, technological, competitive, economic, cultural, knowledge, performance etc.
• Identify requirements of employees, customer, supplier, statutory & regulatory bodies and ensure that all the requirements are met.
• Determine, implement, maintain, evaluate and improve required processes.
• Produce records or evidence that system requirements have been met.
• Demonstrate involvement and commitment of top management.
• Establish policies, objectives and procedures.
• Define roles and responsibilities within organization.
• Plan changes to the QMS and take actions to address risks and opportunities as a result of changes.
• Confirm that employees receive applicable training in the quality system requirements.
• Measure, monitor and report the performance of the QMS.
• Benchmark approach for designing product and services.
• Identify and control of outputs that do not conform to the requirement.
• Perform internal audit to analyze the QMS and correct nonconformities.
• Continuous improvement.

Purpose of Quality Management System:

Simply saying, the purpose of Quality Management System is to produce quality products/services and ensure customer satisfaction.

It helps an organization to consistently provide product and services that meet customer requirement, statutory and regulatory requirement through effective application of defined system, processes, policies and procedure.

Why is the Quality Management System important?

With a view to respond to the demand of globalization, growing needs and expectations of existing and potential customers and in an effort to expand into new territories, organizations strive to develop an overall efficient system to maintain and offer constant improvements in the overall performance of the organization. In order to obtain this, organizations go for adoption of QMS.

The QMS is important because it includes all of the activities that an organization does to provide products and services focused on the customer, and this is the reason why organizations are in business. A QMS that includes the necessary processes to meet this goal will help to provide consistent results to customers and other stakeholders, which will provide confidence in organization and offer the foundation for improvement and growth.

For this reason, it is advisable to create QMS by implementing the requirements of a standard that is globally recognized and provides the agreed acceptable processes required to ensure customer satisfaction and improvement.

Elements of Quality Management System:

Here are the different elements of the Quality Management System:

• Quality Objectives: Quality objectives refer to the pre-determined measurable quality goals of a product, process or service. They are established keeping customer requirements and internal system requirements in mind.
• Quality Manual: Quality manual is a document that describes organization’s Quality Management System. It comprises policies, processes and procedures of organization that wishes to demonstrate conformance to the requirements of QMS. Though, Quality Manual is no longer a mandatory requirement, but it is very helpful to outline organization’s approach towards QMS. It should be written in simple language for everyone to understand what is to be done and how to proceed further.
• Organizational Structure and Responsibilities: Organization structure establishes the hierarchy system in an organization. It defines activities related to task allocation, their coordination and flow within the organization. It determines the individuals involved in various actions and how does it decide the course of action for an organization to achieve organizational goals.
• Data Management: Data management in effective way of handling data in order to utilize them for decision making and also to avoid its misuses in application by unauthorized access.
• Processes: A Business process as defined by standard is “A set of related or interacting activities, which transform input into output”. It outlines flow of sequences of activities that transform input elements into results using resources.
• Product/Service Quality Leading to Customer Satisfaction: The ultimate goal of every organization is satisfying its customers and for that, it is of utmost importance that quality products or services are delivered to the customers. This can be achieved by strictly adhering to the quality objectives and the quality manual.
• Continuous Improvement: Continuous improvement process is constant initiatives taken to improve deliverables. These efforts should be made to ensure ongoing improvement in various business processes.
• Quality Instrument: In order to make quality deliverables available to the customers, it is important to use quality instruments. This makes efficient working processes a reality.
• Document Control: Every step in each process needs to be documented. It should be done sincerely. Simple language should be put into use which is understandable by one and all and should get rid of ambiguity by being precise. Controlling a document is equally important. A document can be controlled by allotting a document number, revision and date. Also, there should be restriction for unauthorized access.

Benefits of Quality Management System:

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

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

 Other additional benefits include:

• Brings standardization and uniformity in business practices across the globe.
• The ability to consistently provide product and services that meet applicable statutory and regulatory requirements.
• Achieve perfection.
• Preventing mistakes.
• Lowering cost.
• Be efficient in actions taken.
• Marketing of business gets a makeover and is more effective.
• Penetrate new markets and regions.
• Continuous improvement of processes.

Seven principles of Quality Management System:

The ISO 9001 Quality Management System is based on seven principles, each one a critical focus for a system QMS. These seven principles are:

• Customer focus: Focusing on customer needs and expectation.  This customer focus is the foundation of improving customer satisfaction.
• Leadership: In order for the QMS to succeed, top management needs to provide resources and adequate ongoing review of the system.
• Engagement of people:  Participation and involvement of the people of organization is very important for effectiveness of QMS.
• Process approach: The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization.
• Improvement: A company will only survive if it gets better over time, so the QMS needs to focus on finding ways to do things better.
• Evidence-based decision making: Proper management cannot be done if it is not known that how a process is actually working. By basing decisions on facts, QMS can be managed and improved in better way.
• Relationship management:  Managing relationship with employees, customers, suppliers and other interested parties is a key for growth and sustainability of QMS.

What is necessary to create Quality Management System?

• Identify the main processes.
• Establish the sequence and interaction of processes.
• Identify the criteria and methods necessary to ensure the effectiveness of both work and process management.
• Ensure the availability of resources and information necessary to support work and monitor processes.
• Observe measure and analyze processes.
• Take the measures necessary to achieve the planned results and continuously improve the processes.