Quality Management Systems

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PEN Associate, LLC Provides the following services for:

ISO9001:2015, AS9100, IATF16949, ISO13485, ISO14000, ISO18000.

- Training to the Standard

-Internal Auditor Training

-Guidance in Implementation

-First Party Internal Audit Support

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The Eight Principles of a Quality Management System

1. Customer-focused organization.

The very relevance of an QMS depends on its customers; it must, therefore, understand and meet their needs. The QMS should establish a soundworking relationship with relevant community sectors through formal working groups and regular meetings. The Context of the Organization is needed to develop strategies. Strategies such as these will provide a clear understanding and appreciation of the needs and expectations of customers, the impact of specific products and the environment in which they operate. Ideally an QMS will not only meet its customers’ expectations but will actually exceed them.

2. Leadership.

Sound leadership is fundamental to the success of an organization. The QMS leadership should establish a vision or a desired future for the organization. It should clearly demonstrate in practice an ongoing commitment to the QMS and create an environment that encourages people to achieve the objectives of the QMS.

Leadership will ensure the risks and opportunities are clearly defined and understoosd at every level of the organization.

3. Involvement of people.

An QMS relies on its staff and should ensure that they are adequately involved in the delivery of its products. However, in order to ensure the quality of its products, it should equip its staff with the appropriate skills and knowledge and provide them with ongoing professional development opportunities.

4. Process approach.

An QMS will be more efficient and effective when it uses a process approach to the delivery of its products. The processes should provide clearly defined accuracy standards and structured formats for all products and services. This enables the efficient management of resources and activities for the delivery of products and services.

5. System approach to management.

The QMS is advised to use a system approach, which requires the identification, understanding and management of interrelated processes. This could start, for example, with the collection of basic observations and the systematic integration of appropriate information and data via various interrelated processes up to the provision of a suite of forecast and warning products. The system approach to management is critical to the delivery of high-quality QMS products.

6. Continual improvement.

This should be an ongoing objective of all QMS's, which is achieved through the application of all the principles. The International Organization for Standardization has emphasized that a key approach to continual improvement entails the development of a close working relationship with the customers of an organization combined with an ongoing commitment to continually improve its overall performance.

7. Factual approach to decision-making.

An QMS will perform better when it makes an informed decision based on facts. It should measure and evaluate its products, processes and performance. Analysis of this data/information will enable informed decision-making and improvement in service delivery.

8. Mutually beneficial supplier relationships.

The QMS has a number of mutually beneficial relationships with internal and external customers, partners, specific community sectors, international and national organizations and the various levels of government. These relationships should be appropriately managed and nurtured to ensure benefits to the QMS.

PEN has implemented Quality Management Systems in over 300 companies.

Contact PEN for all your QMS needs.

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