Iso9001 Notes.docx

1

What is Quality?

The term ‘quality’ is perceived differently by different people. “Quality is the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs” Quality certification is becoming a critical component for both manufacturing and service organizations competing in world markets. As explained by Rao, Ragu-Nathan and Solis (1997:335), the reasons why companies are looking for quality certification range from maintaining their position with other companies in their markets that are already certified to getting a step ahead of their competitors. 2

ISO 9000

The International Organisation for Standardisation (ISO) is a non- governmental organization founded in 1946 in Geneva, Switzerland. Its mandate is to promote the development of international quality standards to facilitate the exchange of goods and services worldwide. ISO comprises of national standards bodies represented in 170 countries around the world. ISO 9000 is viewed as the basis for quality management since it addresses the issue of setting and implementing a management system that produces consistent products at a particular level of quality. ISO 9000, through standardization of procedures and processes, assures consistency in product and service quality. The ISO 9000 series is different from other quality standards existing in the world today, in that it develops comprehensive quality assurance management systems for everything from design of a product to the servicing of the customer after the product has been delivered. 2.1

The Structure of ISO 9000

In 1987, the ISO Technical Committee 176 developed the first series of International Standards for the quality system. However, with their adoption by the European Community and worldwide emphasis on quality and economic competitiveness, ISO 9000 was first initiated in 1994.

After six years, there was a second revision of the ISO 9000 and after that it came up to be known as the ISO 9001:2000. ISO 9001:2000 is a standard for quality management systems. QMS based on ISO 9001:2000 provide a sound foundation on which TQM programmes can be built. It has been widely acclaimed that ISO 9001:2000 is a first big step in a TQM programme as it proposes greater flexibility and emphasizes on the continual improvement of the overall performance of the organization. The purpose of the ISO 9001 standard is to assist companies of various sizes in any sector to implement and operate an effective QMS by enhancing the firm’s ability to design, produce, and deliver quality products and services.The standard provides guidelines on procedures, controls, and documentation for a QMS to help a company identify mistakes, streamline its operations, and maintain a consistent level of quality. 2.2

Quality Management System

A quality management system (QMS) is defined as “an assembly of components, such as the management structure, responsibilities, processes and resources for implementing total quality management” (Oakland, 2003:208). A quality management system encourages organizations to analyze customer requirements, define the processes, which contribute to the achievement of a product, satisfying the customers and to keep the processes under control. A QMS can provide the framework for continual improvement. It provides confidence to the organization and its customers that it can fulfill both product and customer requirements. According to John Oakland (2003:207), the aim of a good QMS is “to provide the operator of the process with consistency and satisfaction in terms of materials, equipments and methods.”

CONTINUAL IMPROVEMENT

Customers (and other interested parties)

Resource management

Requirements

Customers (and other interested parties)

Management responsibility

Input

Measurement, analysis and improvement

Product Realization

Satisfaction

Output Product

Key Value-adding activities Information flow

Figure 3.1:

The Quality Management System Model

The QMS model integrates the four main clauses of ISO 9001:2008 series, Management

Responsibility,

Resource

Management,

Product

Realization

and

Measurement, Analysis & Improvement. These clauses interact with each other to form a vertical loop which will lead to continual improvement. It should be noted that the QMS model is based on Deming PDCA Cycle (Plan-Do-Check-Act), which also results in continual improvement. The organization must focus on customer needs. In other words, the management is responsible to identify customer requirements which are being used as inputs to the product/ service realization. Management is also responsible to identify and create a

framework of interrelated processes which will enable product/service realization. These processes must be supported by adequate and appropriate resource inputs such as labour, machinery, equipment, raw materials, vehicles etc. It is only then that the products or services can be realized. These resources must be managed effectively and efficiently. Product realization includes the entire range of activities or processes from processing of customer’s requirement to delivery of products to customers. To ensure continual improvement, the organization should continuously improve its processes and resources through measurement, analysis and improvement. It is important for the organisation to ensure that products are made and services are delivered according to the needs and expectations of customers, as this will gauge the level of customer satisfaction. 3.0 QUALITY MANAGEMENT PRINCIPLES ISO 9001:2008 embraces eight quality management principles. CUSTOMER FOCUS Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations. Customer focus means making customers at the forefront of decision-making processes. The organization must be in a position to identify customers’ needs and expectations not only in the present but also in the future, that is, the organization must be able to anticipate changes in customers’ demands. Through, for example, market research and market survey. Some organizations have some mechanisms to collect feedback through a Guest Satisfaction Questionnaire.

The impression can be positive or negative.

impression will be reviewed by management and corrective actions will be taken. Benefits: 

Customer satisfaction which leads to customer retention (customer loyalty).

This



Increase in market share (can become market leader).

LEADERSHIP

Leaders establish unity of purpose and direction of the organization.

They should

create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives. To be ISO certified, there need to be a degree of leadership, to help in achieving our objectives. Leadership is important because it brings a sense of direction and a unity of purpose and helps in the achievement of organizational goals. It makes people channel in a certain direction thus achieving goals. A good leader should transform people to achieve excellent performance. The approach is certainly important. Benefits: 

Good leadership leads to timely achievement of goals and objectives.



Improved motivation among employees.



Improved performance.

INVOLVEMENT OF PEOPLE People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.

People might look

committed but if they are not involved in their work, there is no performance. Improvement of people is necessary for achievement of goals and objectives. Once people are involved in the organization, there is empowerment. Involvement might also mean involving the people in the process of quality improvement. Some aspects of decision-making might be delegated to them.

Benefits: 

Achievement of goals.



Quick decision-making.



Improved motivation.



Flexible organization (fast to react to change, to deal with a customer’s complaint).



Improved customer satisfaction.

PROCESS APPROACH A process is any activity or set of activities that uses resources to transform inputs into output. According to Charantimath (2003:179), the systematic identification and management of the various processes employed in an organization and interaction between such processes may be referred to as the process approach to management. For an organization to operate effectively, it has to identify the various processes and manage the numerous interrelated and interactive processes to achieve the desired results. Top management should establish the responsibilities of each employee in managing the key activities. Besides, they should measure, analyze and help to detect any mismanagement or misuse of the resources within the organization. The key benefit of managing effectively and efficiently the processes is that it helps to detect areas requiring improvement. Benefits: 

Improved efficiency.



Improved productivity.



Less cost incurred (can sell goods at lower prices).

SYSTEM APPROACH TO MANAGEMENT Processes need to be structured in such a way that the objectives of the organization are met in the most effective and efficient manner. Top management should be able to understand the interdependencies between processes and see how they can integrate into one system. It is important to define the roles and responsibilities of each employee to achieve the objectives and thereby reducing the cross- functional barriers. Moreover,

the measurement and evaluation of the activities need to be done on a frequent basis to detect any deficiency in the system. It is also important to constantly identify if the processes of the system are functioning as per requirement. Benefits: 

Good coordination between activities.



Internal customer satisfaction (the one who makes the request is the internal customer).



The system approach leads to a very stable and efficient organization. (Smooth flow of work, people understands how processes are interconnected.)

CONTINUAL IMPROVEMENT Continual improvement should be the permanent objective of an organization. “Very good is not good enough”. The PDCA cycle (figure 2.2 below) was developed by W. Edwards Deming.

PLAN CONTINUAL

ACT

DO

CHECK Figure 2.2: The PDCA cycle That is: 

Plan what we are going to do;



Do it;



Check that we have done what we planned to do;

IMPROVEMENT



Review what we have done and Act to improve, then go back to planning.

This will bring the system full circle in the performance of the quality management system, hence resulting in continuous improvement.Benefits: 

Customer satisfaction.



Improve corporate image (positive image).



Continual improvement approach will ultimately help the organization to build a sustainable competitive advantage.

FACTUAL APPROACH TO DECISION MAKING This principle consists of decision- making based on factual analysis of information corroborated by experience and intuition (Padma et al., 2006). According to this approach, it is easier to argue for a well-founded decision by referring to accessible documents. Hence, this enables all parties to understand the different processes within the system. Benefits: 

Effective decision-making.

MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIP An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. The key benefits of such a principle are that it leads to increased ability to create value for both parties and it helps in optimizing costs and resources. Maintaining a good relationship with the suppliers ensures timely delivery of raw materials and good quality products by making use of the Just-In-Time approach. Benefits: 

High quality materials.



Just-In-Time.



Customer satisfaction.

4.0 ROAD MAP TO CERTIFICATION Many reasons may motivate an organization to be ISO Certified. It may be to improve the overall business performance, promote the organization as a leader in its field, impress an important customer, and land a contract or any other reasons.

The

certification usually takes a minimum of 6 months. In fact the road map to certification includes the different phases that lead to ISO 9001 Certification: 1.0 Training of personnel in QMS Development, Internal Quality Audit and Quality Awareness It is important to provide employees at operational level with an awareness session in quality management. Line management, middle management & administrative staff will be required to follow training in QMS development and in Internal Quality Audit. 2.0 Development of QMS, that is, developing the Quality Manual The quality manual should be developed in line with ISO 9001:2008 Standards. The most important part of a quality manual is the documentation of all the activities performed in an organization. 3.0 Implementation of the QMS The quality procedures together with the policies developed in the quality manual should be implemented. 4.0 Internal Quality Audit (IQA) The next stage in the road map is the conduct of the Internal Quality Audit, which is an assessment of the actual quality management system. The audit is performed by internal members of the organisation. 5.0 Management Review Management review is usually chaired by the General Manager or the Quality Management Representative and must be attended by all the heads of department meet to review the performance of the organization. For example, assess the number of defects, the supplier’s performance, the internal quality audit results or the customer satisfaction.

6.0 Third Party Audit This audit is conducted by Certifying bodies. They will perform an audit of all activities identified in the quality management system and will report whether the organization is in line with the requirements of the ISO standards. If it is the case, they will recommend the ISO 9001 Certification. If it is not the case, they will need to submit a report to how to improve the effectiveness of the quality management system.