– Er. Khagendra Basnet
International Standardization Organization (ISO) is an independent, non governmental international organization with a membership of 162 national standard bodies which formulate standards used in world-wide market place.
ISO develops standards by experts coming from the industrial, technical and business sectors with relevant knowledge. ISO formulate standards and related documents address economic, environmental and social dimensions.
What are standards?
A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and service are fit for their purpose. They give world class specifications for products, service and systems, to ensure quality, safety and efficiency.
What is Quality Management System (QMS)?
The quality management is coordinated activities to direct and control an organization with regards to quality. The set of interrelated or interacting elements of an organization to establish policies and objectives and processes to achieve those objectives with regards to quality is quality management system.
There are several standards in the ISO 9000 family provide a vehicle for consolidating and communicating concepts in the field of quality management. The ISO 9001:2015 Quality Management Systems – Requirements is among them. This standard has been revised fifth time in 2015. ISO 9001:2015 QMS requirements cancels and replaces the 4th edition (ISO 9001:2008), which has been technically revised, through the adaptation of revised clauses, sequences and adaptation of revised quality management principles and of new concepts. ISO 9001:2015 intended that implementation of this standard enable organizational capability to developed quality planning with adequate support and operation for quality improvement through periodic performance evaluation. These all are strongly backed up with leadership in every level of organization to ensure customer satisfaction from organizational products and services. The compliance of ISO 9001:2015 QMS requirements is the basis for organizational QMS certification where as other ISO 9000 family standards are supporting guidance documents for organizational quest for quality improvement.
The primary purpose of ISO 9001 certification is to give confidence to customers that products and services meet the needs and expectations of customers and other stakeholders and improve the capability of organizations to do this.
ISO 9001:2015 QMS is based on the seven quality management principles and three fundamental concepts such as
- Process approach,
- PDCA (Plan – Do – Check – Act ) cycle and
- Risk based thinking.
Seven Quality Management Principles are:
- Customer focus
The primary focus of organizational quality management is to meet its customer requirements and to strive to exceed customer expectations. For sustainable business organization has to attract and retains the confidence of customers and other interested parties. The increased customer value, satisfaction, loyalty brings repeat business and hence enhanced reputation of the organization that means more customer base which increased revenue and market share.
There should be development of leaders at all levels of organization who establish unity of purpose, direction and create conditions in which people are engaged in achieving the organization’s quality objectives. Creation of unity of purpose, and the direction and engagement of people enable an organization to align its strategies, policies, processes and resources to achieve its objectives.
- Engagement of people
Competent, empowered and engaged people at all levels throughout the organization are essential to enhance the organization’s capability to create and deliver value. In order to manage an organization effectively and efficiently, it is important to respect and involve all people at all levels. Recognition, empowerment and enhancement of competence facilitate the engagement of people in achieving the organization’s quality objectives.
- Process approach
Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system. The QMS consists of interrelated processes. Understanding how results are produced by this system enables an organization to optimize the system and its performance.
Successful organizations have an ongoing focus on improvement. Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities.
- Evidence-based decision making
Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.
- Relationship management
For sustained success, organizations manage their relationships with interested parties, such as providers. Sustained success is more likely to be achieved when the organization manages relationships with all of its interested parties to optimize their impact on its performance. Relationship management with its provider and partner networks is of particular importance.
Developing the QMS using fundamental concepts and principles:
Any organization’s characteristics resemble to humans as living and learning social organism. Both are adaptive and comprise interacting systems, processes and activities. The context for organization in which it operates is dynamic and it should adapt to their varying context by developing the ability to cope with changes.
In order to implement the QMS organization should recognize all the systems, processes and activities involved. It needs to be flexible and adaptable within the complexities of the organizational context.
QMS is a dynamic system that evolves over time through periods of improvement. ISO 9001:2015 QMS requirements provides guidance on how to develop and manage those activities that are either already in existence or new in the organization and their suitability regarding the context in which organization operate.
- Process approach:
Organization adopting QMS should understand and manage its interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results. There should be organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced.
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.
Management of the processes and the system as a whole can be achieved using the PDCA cycle with an overall focus on risk-based thinking aimed at taking advantage of opportunities and preventing undesirable results. Figure below shows how processes are developed for QMS.
- PDCA (Plan-Do-Check-Act) cycle:
The PDCA cycle can be applied to all processes and to the quality management system as a whole. Figure below illustrates how ISO 9001:2015 QMS requirements’ clauses can be grouped in relation to the PDCA cycle. There are requirements regarding the planning the organizational quality issues by understanding the internal and external context.
The PDCA cycle can be briefly described as follows:
- Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies; and identify and address risks and opportunities.
- Do: implement what was planned;
- Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives and requirements and report the results;
- Act: take actions to improve performance, as necessary.
- Risk-based thinking:
This is new concept for QMS requirement incorporates in this fifth revision. Risk-based thinking is essential for achieving an effective quality management system. To conform to the requirements of ISO 9001:2015, an organization needs to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects.
ISO 9001 based QMS is implemented and certified by more than millions organizations in 187 countries. ISO 9001:2015 QMS adaptation is strategic decision for an organization since it incorporate the risk based thinking to address the opportunity and associated risk arise due to context of business environment along with process approach focus on managing the activities most efficient and effective ways and PDCA cycle for improvement.
Khagendra Basnet is the Director at Industrial Energy Management Project. He completed his Masters in Industrial Engineering from Indian Institute of Technology (IIT), Delhi. He can be reached at firstname.lastname@example.org.