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Fundamentals of quality management systems as per ISO 9000

Fundamentals of quality management systems as per ISO 9001

1 Rationale for quality management systems

This is one of the fundamentals of quality management systems.The organizations can implement Quality Management Systems to enhance its customer satisfaction. Customers wants their products/ services to satisfy their needs and expectations. These needs and expectations of the customer can be referred to as customer requirement and can be organization’s product specification. The organization may determine customer requirement  by customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealer reports. Customer requirement may also be specified in a contract. Ultimately the customer determines whether he want to accepts the product. The organization needs to improve continually their products and process to enhance customer satisfaction as customer requirements keeps on changing because of competitive pressure and improvement in technology in general.
Implementing quality management system  helps the organizations to analyse customer requirement, determine the process which are needed by the organization to produce product which meet customer requirement and is acceptable by the costumer. It also ensures that processes are under control. Quality management system can be a framework for continual improvement by enhancing customer satisfaction and also satisfaction of other interested parties such as employees, regulatory and statutory authorities,  shareholders and society at large. Implementing Quality management system will give confidence to the customer and organization and other interested parties that the organization will provide products/services which will consistently fulfill requirements.

2 Requirements of quality management systems and requirements for products

This is one of the fundamentals of quality management systems.The requirement for quality management systems and the requirement for the products/services provided by the organizations are different. The Requirements for quality management systems are specified in ISO 9001 standards. This are generic requirements.Generic means that the same standards can be applied to any organization, large or small, whatever its product or service, in any sector of activity, and whether it is a business enterprise, a public administration, or a government department. Generic also signifies that  no matter what the organization’s scope of activity if it wants to establish a quality management system, ISO 9001 standard gives the essential features. ISO 9001 will not provide requirements for the products. The requirements of the products can be specified by the customers, Regulators or the organization itself . The requirement of the product  and its associated process can also be obtained from technical specifications, product standards, process standards, regulatory requirements and contractual agreements.

3 Quality management systems approach

This is one of the fundamentals of quality management systems.To develop and implement a quality management system following should be the approach of the organization.
a) The organization must determine the needs and expectations( requirements)  of the customer and other interested parties.
b) The organization must establish its quality policy and quality objectives.
c) The organization must determine the process needed to attain those quality objectives. Also those responsible for meeting those objective must be identified.
d) Adequate resources must be provide by the organization for the processes identified.
e) Methods to measure the effectiveness and efficiency fo each process must be established.
f) The organization should apply  these measures to determine the effectiveness and efficiency of each process.
g)The organization must determine adequate means to prevent nonconformities and if and nonconformities are identified to eliminate their root cause.
h)The organization should establish a process for continual improvement of quality management system.
The above mentioned approach should also be followed by the organization who wish to maintain and improve their existing quality management system. This will give the organization the confidence in the capability of its process and will ensure the quality of its products. This will also provide the basis for continual improvement. This can lead to increase in customer satisfaction and also satisfaction of other parties, which will ultimately lead to the success of the organization.

4 The process approach

Process  Approach

Process Approach is one of the fundamentals of quality management systems.
Process can be defined as a set of activities which uses resources to transform inputs to outputs. An organization will have numerous interrelated and interacting processes. Output of one process can be input of next process or resource for next process or control for next process. The systematic identification and management of the processes employed within an organization and particularly the interactions between such processes is referred to as the “process approach.”  To effectively implement quality management system, adoption of process approach should be encouraged to manage the organization. From the illustration shown below in process-based quality management system  interested parties play a significant role in providing inputs to the organization. Monitoring the satisfaction of interested parties requires the evaluation of information relating to the perception of interested parties as to the extent to which their needs and expectations have been met.

Model of a process-based quality management system
Model of a process-based quality management system

5 Quality policy and quality objectives

The Organization should establish quality policy and quality objectives to provide a focus and direction to the organization. Quality policy and quality objectives helps the organization in utilizing the resources to achieve the desired results of the organization.The quality policy should provide a framework for establishing the quality objective of the organization which should be consistent with the quality objectives.The quality policy and quality objectives should show a commitment to continual improvement. The quality objectives should be measurable and should have a positive impact on product quality, operational effectiveness and financial performance , thus improving the satisfaction and confidence of interested parties. Both quality policy and quality objectives should be reviewed periodically.

6 Role of top management within the quality management system

This is one of the fundamentals of quality management systems. It is the responsibility of the top management of the organization through its leadership qualities and action by following the Eight principles of quality management and creating an environment where people are fully involved ensure that quality management system operate effectively.
a)The top management should help in establishing and maintain the quality policy and quality objectives of the organization.
b)The top management should promote to increase the awareness, motivation and involvement of quality policy and quality objectives through out the organization.
c) The top management should ensure focus on customer requirements throughout the organization.
d) The top management should ensure that appropriate processes are implemented  so that the  requirements of customers and other interested parties are  fulfilled and quality objectives of the organization are achieved.
e) It is the responsibility of the top management to ensure that an effective and efficient quality management system is established, implemented and maintained  so that the quality objectives of the organization is achieved.
f) The top management should ensure that the necessary resources are available.
g) The top management should review the quality management system periodically;
h) The top management should decide on actions regarding the quality policy and quality objectives.
i) The top management should decide on actions for improvement of the quality management system.

7 Documentation

7.1 Value of documentation

This is one of the fundamentals of quality management systems. Documentation is a value adding activity in the organization which communication the intent of the organization and helps in the consistency of action.
a) Documentation help the organization in achieving the conformity to the customer requirement and help in quality improvement.
b) Documentation help in the provision of appropriate training through the use of documented training procedure.
c) Documentation help in the repeatability of processes and traceability of product.
d) Documentation provides objective evidence.
e) Documentation help us to evaluate the effectiveness and continuing suitability of the quality management system.

7.2 Types of document used in quality management systems

This is one of the fundamentals of quality management systems. To implement quality management systems the organization should have following types of documents
a) Quality manual: Quality manual provides consistent information about organization’s quality management system to customers, suppliers, employees, regulators, shareholder and other interested parties.
b) Quality plans: Quality plan describe how the quality management system is applied to a specific product, project or contract.
c) Specifications: Specification state the requirements.
d) Guidelines: Guidelines states recommendations or suggestions.
e) Documented procedures, work instructions and drawings: They provide information about how to perform activities and processes consistently
f) Records: Records provide objective  evidence of activities performed or results achieved.
Depending on the type and size of the organization, the complexity and interaction of processes, the complexity of products, customer requirements, the applicable regulatory requirements, the demonstrated ability of personnel, and the extent to which it is necessary to demonstrate fulfillment of quality management system requirements, the extent of the quality management system documentation can differ from one organization to another.The documentation can be in any form or type of medium.

8 Evaluating quality management systems

8.1 Evaluating processes within the quality management system

The organization should evaluate the quality management system periodically. The evaluation of the quality management system  can be done by reviewing the system, self-assessments or by conducting audit. The scope of evaluation for the quality management system will be different for audit, self-assessments, and for review. In quality management systems, while evaluating every process the following basic question should be asked:
a) Is the process identified and appropriately defined?
b) Are responsibilities assigned?
c) Are the procedures implemented and maintained?
d) Is the process effective in achieving the required results?
The answers to the above questions can determine the result of the evaluation.

8.2 Auditing the quality management system

A audit can be defined as a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Audits are used to determine the extent to which the quality management system requirements are fulfilled. Audit findings can be defined as a results of the evaluation of the collected audit evidence against audit criteria. Audit findings can indicate either conformity or non-conformity with audit criteria, or opportunities for improvement.  Audit findings are used to assess the effectiveness of the quality management system and to identify opportunities for improvement.
First-party audits are conducted by, or on behalf of, the organization itself for internal purposes and can form the basis for an organization’s self-declaration of conformity. Second-party audits are conducted by customers of the organization or by other persons on behalf of the customer. Third-party audits are conducted by external independent organizations. Such organizations, usually accredited, provide certification or registration of conformity with requirements such as those of ISO 9001. ISO 19011 provides guidance on auditing.

8.3 Reviewing the quality management system

It is the responsibility of the top management to carry out regular systematic evaluations of the suitability, effectiveness and efficiency of the quality management system with respect to the quality policy and quality objectives. It is the responsibility of  the top management to review of the quality policy and quality management, including the need for action for its continual suitability to the changing expectations of customers and other interested parties. Audit reports can be used for review of the quality management system.

8.4 Self-assessment

An organization’s self-assessment is a comprehensive and systematic review of the organization’s activities and results referenced against the quality management system or a model of excellence.An organization must undertake self assessment of its quality management system verify the performance of the organization , to verify the degree of conformance, to identify deficiencies in system, to assess the continued suitability of system to achieve organizational objectives, to find out opportunities for improving the organization’s Quality performance and the degree of maturity of the quality management system.

9 Continual Improvement

This is one of the fundamentals of quality management systems. Quality Improvement – is defined as the part of quality management focused on increasing the ability to fulfill requirements. Continual improvement results from ongoing actions taken to enhance product characteristics or increase process effectiveness and efficiency. This is one of the key characteristics that differentiate a quality management system from a quality assurance system, i.e., being able to improve the effectiveness and efficiency and of a process or activity by setting measurable objectives and using performance data to manage the achievement of these objectives.
Effectiveness is defined as the extent to which planned activities are realized and planned results are achieved. In determining the effectiveness of quality assurance and quality improvement activities, the following questions should be asked:
– To what extent have problems in product or processes been prevented?
– To what extent have planned objectives for quality been met?
Efficiency is defined as the relationship between result achieved and resources used. The measure of efficiency is determined by asking the following:
– Can we get the same output using fewer resources?
– Can we get more output without adding resources?
These questions may be applied to the output of any activity within the quality management system of an organization.
It should be noted that ISO 9001 requires organizations to achieve QMS effectiveness through quality assurance and continual improvement activities. QMS efficiency is desirable, but not currently required by ISO 9001. ISO 9004 provides guidelines that consider both the effectiveness and efficiency of the QMS.
Quality improvement actions may include:
• Measuring and analyzing situations
• Establishing improvement objectives
• Searching for possible solutions
• Evaluating these solutions
• Implementing the selected solution
• Measuring, verifying, and analyzing results
• Formalizing the changes
Review of result gives opportunities for improvement.Feedback from customers and other interested parties, audits and review of the quality management system can also be used to identify opportunities for improvement.

10 Role of statistical techniques

This is one of the fundamentals of quality management systems. The use of statistical techniques can help in understanding variability, and thereby can help organizations to solve problems and improve effectiveness and efficiency. These techniques also facilitate better use of available data to assist in decision making. Variability can be observed in the behaviour and outcome of many activities, even under conditions of apparent stability. Such variability can be observed in measurable characteristics of products ad processes, and may be seen to exist at various stages over the life cycle of products from market research to customer service ad final disposal. Statistical techniques can help to measure, describe, analyse, interpret and model such variability, even with a relatively limited amount of data. Statistical analysis of such data can help to provide a better understanding of the nature, extent and causes of variability, thus helping to solve ad even prevent problems that may result from such variability, and to promote continual improvement.
Guidance on statistical techniques in a quality management system is given in ISO/TR 10017.

11 Quality management systems and other management system focuses

This is one of the fundamentals of quality management systems. The quality management system is that part of the organization’s management system that focuses on the achievement of results, in relation to the quality objectives, to satisfy the needs, expectations and requirements of interested parties, as appropriate. The quality objectives complement other objectives of the organization such as those related to growth, funding, profitability, the environment and occupational health and safety. The various parts of an organization’s management system might be integrated, together with the quality management system, into a single management system using common elements. This can facilitate planning, allocation of resources, definition of complementary objectives and evaluation of the overall effectiveness of the organization. The organization’s management system can be assessed against the organization’s management system requirements. The management system can also be audited against the requirements of International Standards such as ISO9001 and ISO 14001:1996. These management system audits can be carried out separately or in combination.

12 Relationship between quality management systems and excellence models

This is one of the fundamentals of quality management systems. The approaches of quality management systems given in the ISO9000 family of standards and in organizational excellence models are based on common principles. Both approaches
a) enable an organization to identify its strengths and weaknesses,
b) contain provision for evaluation against generic models,
c) provide a basis for continual improvement, and
d) contain provision for external recognition.
The difference between the approaches of the quality management systems in the ISO 9000 family and the excellence models lies in their scope of application. The ISO 9000 family of standards provides requirements for quality management systems and guidance for performance improvement; evaluation of quality management systems determines fulfillment of those requirements. The excellence models contain criteria that enable comparative evaluation of organizational performance and this is applicable to all activities and all interested parties of an organization. Assessment criteria in excellence models provide a basis for an organization to compare its performance with the performance of other organizations.

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