THEORETICAL FOUNDATION … 8 1.1 What is ISO 9001:2000
The Standards ISO 9001:2000 analysis …
ISO 9001:2000 is the most recent iteration of a long-established quality management standard, utilized by over 300,000 organizations globally This standard outlines essential requirements for implementing an effective quality management system within an organization.
• Demonstrate its ability to provide consistently a product that meets customer and applicable regulatory requirements and to:
• Address/enhance customer satisfaction through the effective application of the system, developing processes for continual improvement and the prevention of errors and mistakes
The ISO 9001: 2000 contains five requirements sections, each dealing with one of the fundamental building blocks required by any process These are:
This section outlines the essential requirements for a Quality Management System (QMS) and its documentation, which serve as the foundation for effective management Organizations are encouraged to evaluate their management processes, understand their interactions, identify necessary resources, and establish methods for measuring and monitoring these processes Additionally, an action plan for implementation should be developed Furthermore, the section specifies the documentation requirements for the QMS, including quality manuals, procedures, records, and guidelines for controlling this documentation to ensure efficient system operation.
Top management holds the strategic responsibility for the effective management of quality management systems within the organization They must demonstrate a commitment to developing these systems by fostering staff awareness of customer requirements and ensuring compliance with statutory and regulatory obligations Establishing a clear quality policy and setting specific objectives are essential steps, along with strategic planning to achieve these goals Additionally, top management should facilitate transparent internal communication and regularly review the management system to ensure its continued effectiveness.
Effective execution of processes requires skilled personnel and adequate physical resources Competent individuals must perform their tasks, while the work environment and available resources should be designed to meet customer needs efficiently.
These are the processes necessary to produce the product or to provide the service Determine the quality & objectives for the products, requirements of customers
To ensure quality and satisfaction, it is essential to monitor and validate the product while effectively communicating with customers This process transforms inputs into valuable outputs In the context of a service organization, this could involve guiding tourists on tours across the country, enhancing their overall experience.
To effectively monitor system performance, it is essential to measure key metrics related to customer satisfaction, internal management audits, processes, and product quality By analyzing these metrics, including any defects or performance shortfalls, valuable insights can be gained to enhance both systems and products as needed.
The five essential building blocks are crucial for any process, as the absence of even one disrupts the ability to maintain a controlled process This understanding is reflected in the new standard, which emphasizes the quality system as an interconnected series of processes.
To conduct a process analysis, one must begin by identifying the inputs, followed by a detailed examination of the process through its various stages This involves assessing how the process is controlled and ensuring that the outputs meet the required standards.
When a customer places an order, the organization must follow a series of steps to transform that order into a reservation The process begins with the customer order as the input and culminates in the organization's internal documents, resources, and services that facilitate the delivery of the desired service.
To effectively analyze the process, it is essential to identify and evaluate the inputs, examine the control mechanisms, and assess the outputs This evaluation may necessitate investigating methods beyond the documented procedures to ensure comprehensive control of the process.
Control mechanisms, such as control charts, process flow diagrams, and operative training, are essential for ensuring competency within an organization Regardless of the chosen method, it is crucial to gather evidence demonstrating the effectiveness of these controls Ultimately, the true measure of effectiveness lies in assessing whether the process outcomes align with the initial inputs.
In the research process, the output is assessed to ensure it aligns with the organization's requirements, while also confirming that the process operates under the controlled conditions established by the organization.
Research of processes should result in a logical research of the activities in carrying out the various functions required to supply customers with a product or service which meets their needs
Organizations can demonstrate their compliance with ISO 9001:2000 by making exceptions in clause 7 As stated in clause 1.2 of ISO 9001:2000, exclusions are permitted only for specific requirements within clause 7, provided that these exclusions do not hinder the organization's ability or responsibility to deliver products that meet customer and regulatory standards.
Such exclusion may find their justification in:
The character of the organization
The character of the product
Exceeding the allowed exceptions in ISO 9001:2000 can jeopardize compliance claims This includes instances where regulatory requirements permit exceptions that surpass those specified by ISO 9001:2000.
1.5.1 Introduction The ISO 9000 Family of standards will be based on these Quality Management Principles With growing global competition, quality management is becoming increasingly important to the leadership and management of all organizations
Process approach
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.[ISO 9001:2000]
For an organization to operate efficiently, it must identify and manage interconnected activities A process can be defined as an activity that utilizes resources to transform inputs into outputs Typically, the output of one process serves as the input for the subsequent process The implementation of a systematic approach to these processes, along with understanding their interactions and effective management, is essential for organizational success.
The process approach offers significant benefits by ensuring continuous oversight of the connections between individual processes within a system, as well as their interactions and combinations This method enhances overall efficiency and effectiveness, aligning with the principles outlined in ISO 9001:2000.
Incorporating a quality management system highlights the significance of understanding and fulfilling requirements, evaluating processes for their added value, measuring process performance and effectiveness, and fostering continual improvement through objective assessment.
The process-based quality management system model, illustrated in Figure 1, highlights the interconnections between clauses 4 to 8, emphasizing the critical role of customers in defining requirements as inputs To ensure customer satisfaction, it is essential to evaluate customer perceptions regarding whether the organization meets their needs This model encompasses all the requirements of the International Standard, although it does not detail specific processes Additionally, the "Plan-Do-Check-Act" (PDCA) methodology is applicable to all processes, which involves establishing objectives (Plan), implementing processes (Do), monitoring and measuring outcomes (Check), and taking actions for continuous improvement (Act).
Figure 1.5: Model of process–based quality management system