What Is ISO9001?

The International Organization for Standardization (ISO) 9001 International Standard is a framework for building a process-based Quality Management System (QMS). ISO 9001 is the one standard within the ISO 9000 family that requires certification and is a core component of additional standards, such as AS9100 and ISO/IEC 17025. Illustrated below, ISO’s process approach is the focal point of the QMS principles outlined in the standard. In this context, a process is defined as an activity or set of activities using resources and managed in order to enable the transformation of inputs into outputs.

The ISO 9001 standard enables an organization to build a framework that integrates product delivery with management systems and continuous improvement based on both customer feedback and internal quality processes [iso.org].

Does the system of linked organizational processes established to deliver a product or service have the ability to meet customer needs, statutory, regulatory, and internal requirements? The process approach, simplified below, is a set of guiding principles that can be applied organizations in virtually any field and any number of people to effectively answer these questions.

Linked processes within an organization can work in series or parallel to one another, emphasizing the critical nature of timely feedback, resource, and time management.

The general requirements outlined by the ISO 9001 International Standard ensure organizations:

1. Determine the processes needed for the QMS and their application

2. Determine the sequence and interaction of these processes

3. Determine criteria and methods needed to ensure that both the operation and control of these processes are effective

4. Ensure the availability of resources and information necessary to support the operations and monitoring of these processes

5. Monitor, measure where applicable, and [analyze] these processes

6. Implement actions necessary to achieve planned results and continual improvement of these processes

Organizationally, ISO has long-standing cooperative agreements with the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF), including the Memorandum of Understanding (MOU).