Question

Define and discuss the seven (7) Basic System Requirements of an ISO9000 - compliant QMS?

Answer 1

The seven basic system requirements of an ISO 9000 compliant quality management system are customer focus, leadership, engagement of people, process approach, improvement, evidence based decision making and relationship management.

1.Customer focus: Customer focus refers to focusing on the needs of the customers to create value. The QMS should be able to meet the customer requirements and should always try to exceed the customer expectations. Customer focus would help to attract and retain the confidence of the customers and creates value through better interactions. Other key benefits of customer focus includes improved customer satisfaction and customer loyalty, repeated business, enhanced reputation of the organization, expanded customer base and increases revenue and market share.

2. Leadership: Leadership involves providing direction and guiding the employees towards achieving the quality objectives. The strategies, policies, processes and resources are aligned towards achieving the objectives when the leaders provide unity of purpose and direction. The effectiveness and efficiency in meeting the organization’s quality objectives increases through leadership and there will be better coordination of the organization’s processes. Another benefit is that the capability of the employees increases which help them to deliver the desired result.

3. Engagement of people: Engagement of people refers to involving the people from all levels and it is an important requirement to ensure the capability to create and deliver value. All the employees should be involved in the quality management process and the individuals should be provided with recognition and empowerment to ensure maximum engagement of people. The benefits of ensuring engagement is that the understanding of the people regarding the quality objectives gets improved and people become highly motivated to achieve the quality objectives. Creativity, personal development, more involvement of people, enhanced trust and collaboration and people satisfaction are other benefits.

4. Process approach: Process approach refers to understanding and managing the activities in an organization. The process should be clear and managed well as interrelated processes. Through efficient process approach, consistent results can be delivered. The process approach helps to focus on key processes and find the opportunities for improvement. Optimized performance can be achieved by ensuring effective process management and efficient use of resources.

5. Improvement: The organization should focus on improvement to ensure success. Improvement would help the organizations t ensure the current level of performance. Improvement also helps to react to the changes in the environment and to create new opportunities. Improved performance leads to customer satisfaction and innovation also can be fostered with the help of improvement.

6. Evidence based decision making: It is defined as the decisions based on analysis and evaluation of data. QMS require the decisions to be made based on analysis and evaluation of data to produce the desired results. Evidence based decision making helps to reduce the uncertainty and increase confidence while making decisions. it helps to improve the process performance assessment and ability to achieve the objectives.

7. Relationship management: It is the management of relationship with the interested parties like suppliers. The organization should be able to manage the relationships well. These parties can affect the performance of the organization and the success of the organization depends on how well the relationships are managed. Key benefits of relationship management include enhanced performance, common understanding of goals and values, increased capability and stable flow of goods and services through well managed supply chain.