What is ISO 9001 ?
ISO 9001 is an International Standard that gives requirements for an organization’s Quality Management System (QMS). It is part of a family of standards published by the International Organization for Standardization (ISO) and often referred to collectively as the “ ISO 9000 series ” or “ ISO 9000 family ”. For this reason, you may sometimes hear your suppliers refer to being “ ISO 9000 certified ”, or having an “ ISO 9000-compliant QMS ”. This will normally mean that they are claiming to have a QMS that meets the requirements of ISO 9001, the only standard in the ISO 9000 family that can be used for the purpose of conformity assessment. It is important to understand, however, that ISO is the body that develops and pub- lishes the standard – ISO does not “certify ” organizations. The objective of ISO 9001 is to provide a set of requirements that, if effectively implemented, will give you confidence that your supplier can consistently provide products and services that :
- Meet your needs and expectations.
- Comply with applicable regulations.
ISO 9001 adopts a risk-based ("preventive") approach to quality that covers a wide range of topics, including your supplier’s top management commitment to quality, its customer focus, the adequacy of its resources, employee competence, process management (for production, service delivery and relevant administrative and support processes), quality planning, design of the products and services it provides, review of incoming orders, purchasing, the appropriate monitoring and measurement of its processes, products and services needed to ensure conformity, its processes to resolve customer complaints, corrective actions, and a requirement to drive improvement. Last but not least, there is a requirement for your supplier to monitor your perceptions about the quality of the products and services it provides to you.
ISO 9001 does not define specific requirements for the products or services you are purchasing. It is up to you to make your own needs and expectations clear to your supplier. You might, for example, refer to product or service specifications, drawings, national or international standards, supplier’s catalogues, or other documents as appropriate.
What does "conformity to ISO 9001" mean?
This means that your supplier has established a systematic approach to quality management and is managing its business to ensure that your needs are clearly understood, agreed and fulfilled. A statement of conformity to ISO 9001 should not, however, be considered a substitute for a declaration or statement of product or service conformity.