Fundamentals of Quality Management Systems

Fundamentals of Quality Management Systems

1.0 Rationale for quality management systems

Organizations offer products intended to achieve customer satisfaction. The ISO 9000 family of standards on quality management systems can assist organizations in achieving this objective.

Customers require products with characteristics that satisfy their needs and expectations. These needs and expectations are expressed in product specifications and collectively referred to as customer requirements. Customer requirements may be specified contractually by the customer or may be determined by the organization itself. In either case, the customer ultimately determines the acceptability of the product. Because customer needs and expectations are changing, organizations are driven to improve continually their products and processes.

The quality management system approach encourages organizations to analyze customer requirements, define the processes that contribute to the achievement of a product, which is acceptable to the customer, and to keep these processes under control. A quality management system can provide the framework for continual improvement to increase the probability of achieving customer satisfaction and the satisfaction of other interested parties. It provides confidence to the organization and its customers that it is able to provide products that consistently fulfill requirements.

1.1  Distinction between requirements for quality management systems and requirements for products

The ISO 9000 family distinguishes between requirements for quality management systems and requirements for products.

Requirements for quality management systems are specified in ISO 9001. Requirements for quality management systems are generic, and applicable to organizations in any industry or economic sector regardless of the offered product category. ISO 9001 itself does not establish requirements for products.

Requirements for products can either be specified by customers or by the organization in anticipation of customer requirements, or by regulation. The requirements for products and, in some cases, associated processes can be contained in, for example, technical specifications, product standards, process standards, contractual agreements and regulatory requirements.

1.2  Quality management systems approach

An approach to developing and implementing a quality management system consists of several steps including the following:

a)    Determining the needs and expectations of the customer.

b)    Establishing the quality policy and quality objectives of the organization.

c)    Determining the processes and responsibilities necessary to attain the quality objectives.

d)   Establishing measures for the effectiveness of each process towards attaining the quality objectives.

e)    Applying the measures to determine the current effectiveness of each process;

f)    Determining means of preventing nonconformities and eliminating their causes;

g)    Looking for opportunities to improve the effectiveness and efficiency of processes;

h)    Determining and prioritizing those improvements which can provide optimum results;

i)     Planning the strategies, processes and resources to deliver the identified improvements.

j)     Implementing the plan.

k)    Monitoring the effects of the improvements.

l)     Assessing the results against the expected outcomes.

m)   Reviewing the improvement activities to determine appropriate follow-up actions.

A similar approach is applicable to maintaining and improving an existing quality management system.

An organization that adopts the above approach creates confidence in the capability of its processes and the reliability of its products, and provides a basis for continual improvement. This can lead to increased customer satisfaction and to the success of both the organization and its customers.

1.3  The process approach

Any activity that receives inputs and converts them to outputs can be considered as a process.

For organizations to function effectively they have to identify and manage numerous interlinked processes. Often, the output from one process will directly form the input into the 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.

This International Standard encourages the adoption of the process approach to manage an organization.

QMS-Feedback

figure 1

 The model of the process approach in Figure 1 illustrates a generic quality management system. The model recognizes that interested parties play a significant role during the process of defining requirements. Satisfaction measures are used as feedback to evaluate and validate whether the requirements have been met.

1.4    Purpose and benefits of establishing quality policy and quality objectives.

Quality policy and quality objectives are established to provide a focus to direct the organization. Both determine the intended results and assist the organization to apply its resources to achieve these results. The quality policy provides a framework for establishing and reviewing quality objectives. The quality objectives need to be consistent with the quality policy and the commitment to continual improvement. and their achievement needs to be measurable. The achievement of quality objectives can have a positive impact on product quality, operational effectiveness and financial performance and thus on the satisfaction and confidence of interested parties.

1.5  Role of top management within the quality management system

Through leadership and actions, top management can create an environment where people are fully involved and in which a quality management system can operate effectively. The quality management principles (see 0.2) can be used by top management as the basis of its role, which is:

a)    Establishing the quality policy and quality objectives of the organization.

b)    Ensuring focus on customer requirements throughout the organization.

c)    Ensuring that appropriate processes are implemented to enable customer requirements to be fulfilled and quality objectives to be achieved.

d)     Ensuring that an effective quality management system is established, implemented and maintained to achieve these objectives.

e)     Ensuring the availability of necessary resources.

f)     Comparing the achieved results against. the quality objectives set.

g)     Deciding on actions regarding the quality policy and quality objectives.

h)     Deciding on actions for improvement.

1.6 Documentation

1.6.1 Value of documentation

Documentation enables communication of intent and consistency of action. It is therefore a necessary element within a quality management system. Its use contributes to:

a)    Achievement of product quality and quality improvement.

b)    Provision of appropriate training.

c)    Ensured repeatability and traceability.

d)   Provision of objective evidence.

e)    Evaluation of the effectiveness of the system.

The production of documentation should not be an end in itself but should be a valu~adding activity.

1.6.2  Types of document used in quality management Systems

There are several types of document used in quality management systems:

a)    Documents that provide consistent information, both internally and externally. about the organization’s quality management system; such documents are referred to as quality manuals.

b)    Documents that describe how the quality management system is applied to a specific product, project or contract; such documents are referred to as quality plans.

c)    Documents that provide consistent information about how to perform activities; such documents are referred to as procedures.

d)   Documents that provide objective evidence of activities performed or results achieved; such documents are referred to as records.

Each organization determines the extent of documentation required and the media to be used. This depends on factors such as The type and size of the organization, the complexity and interaction of processes, the complexity of products, the significance of 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.

1.7 Evaluating quality management systems

1.7.1 General

When evaluating quality management systems, there are four basic questions that should be asked in relation to every process being evaluated.

a)   Is the process identified and appropriately described?

b)   Are responsibilities assigned?

c)   Are the procedures implemented and maintained?

d)   Is the process effective in providing the required results?

The collective answers to the above questions can determine the outcome of the evaluation. Evaluation of a quality management system can vary in scope and encompass a range of activities, such as auditing and reviewing the quality management system, and self-assessments.

1.7.2 Auditing the quality management system

Audits are used to evaluate conformance to quality management system requirements and effectiveness in meeting quality requirements and objectives. Results of audits can be used 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 audit service organizations. Such organizations, usually accredited, provide certification or registration of conformity with requirements such as those of ISO 9001.

1.7.3 Reviewing the quality management system

One role of top management is to carry out regular systematic evaluations of the suitability, adequacy, effectiveness and efficiency of the quality management system with respect to the quality policy and objectives. This review can include consideration of the need to adapt the quality policy and objectives in response to changing needs and expectations of interested parties. The review includes determination of the need for actions.

Amongst other sources of information, audit reports are used for review of the quality management system.

1.7.4 Self-assessment

An organization’s self-assessment (see ISO 9004:2000, 8.2.1.5) is a comprehensive, systematic and regular review of the organization’s activities and results referenced against the quality management system or a model of excellence.

The use of self-assessment methodology can provide an overall view of the performance of the organization and the degree of maturity of the quality management system. It can also help to identify areas requiring improvement in the organization and to determine priorities.

1.8  Continual improvement

Improvement refers to the actions taken to enhance the features and characteristics of products and/or to increase the effectiveness and efficiency of processes used to produce and deliver them. Such actions include the following:

a)    Defining, measuring and analyzing the existing situation.

b)    Establishing the objectives for improvement.

c)    Searching for possible solutions.

d)   Evaluating these solutions.

e)    Implementing the selected solution.

f)    Measuring, verifying, and analyzing results of the implementation.

g)    Formalizing changes.

Results are reviewed, as necessary, to determine further opportunities for improvement. Audits, customer feedback and review of the quality management system can also be used to identify opportunities. Improvement is a continual activity.

1.9 Role of statistical techniques

The use of statistical techniques can help in understanding variability. and thereby help organizations to solve problems and improve efficiency. These techniques also facilitate better use of available data to assist in decision-making.

Variability can be observed in the behavior and outcome of many activities, even under conditions of apparent stability. Such variability can be observed in measurable characteristics of products and processes, and may be seen to exist at various stages over the life cycle of products from market research to customer service and final disposal.

Statistical techniques can help to measure, describe, analyze, 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 and even prevent problems that may result from such variability, and promote continual improvement.

1.10 Quality management systems and other management system focuses

The quality management system is that part of the organization’s management system that focuses on the achievement of outputs (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 assessment 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 ISO 9001 and ISO 14001. These management system audits can be carried out separately or in combination.

1.11     Relationship between quality management Systems and organizational excellence models

The approaches of quality management systems given in the ISO 9000 family of standards and in organizational excellence models are based on common principles. They both:

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 ISO 9000 family of quality management systems 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 requirements. The excellence models contain criteria that enable quantitative evaluation of organizational performance and this is applicable to all activities and all interested parties of an organization. Assessment criteria in excellence models permit benchmarking.

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