ISO 9001 standard deals with the fundamentals of quality management systems with the eight management principles as the base. ISO 9001 standard is one of the most widely used management tools across the globe. The ISO 9001 standard is generic in nature and is applicable to any sector regardless of type, size and product or service. The ISO 9001 standard is basically adopted from the MIL standards, later released as an ISO standard in 1987. First revision in 1994, second revision in 2000, third revision in 2008 (presently in use) The ISO 9001 standard requires six mandatory procedures and numerous records in any organization as a requiremen.
Main Requirements of the ISO 9001 Standard :
The requirements cover a wide range of topics, including your supplier's top management commitment to quality, its customer focus, adequacy of its resources, employee competence, process management (for production, service delivery and relevant administrative and support processes), quality planning, product design, review of incoming orders, purchasing, monitoring and measurement of its processes and products, calibration of measuring equipment, processes to resolve customer complaints, corrective/preventive actions and a requirement to drive continual improvement of the QMS. Last but not least, there is a requirement for your supplier to monitor customer perceptions about the quality of the goods and services it provides. ISO 9001 does not specify requirements for the goods or services you are purchasing. That is up to you to define, by making clear your own needs and expectations for the product. You might, for example, refer to product specifications, drawings, National or International product 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 as a substitute for a declaration or statement of product conformity.
How does ISO 9001 help you in selecting a supplier? :
ISO 9001 provides some requirements for the purchasing process that include you as the customer. These requirements address the following topics - Requirements regarding the purchasing information that should be provided so that suppliers clearly understand their customers' needs. the ways in which supplied products can be verified as meeting the requirements of the customer.
Note that whenever ISO 9001 refers to “products? this also includes intangible products like services, or software.
You have an important role to play, by specifying to your supplier what you actually want. You may need to consult with your own internal technical staff (the actual users) in this process. If you don’t do this, you might find that you receive a product that meets all your stated requirements and the applicable regulatory requirements, but which is absolutely wrong for your intended application. So, first of all, you should concentrate on specifying your needs related to the intended use of the product.
To help in this task you may consider the following :
How can you have confidence that your supplier meets ISO 9001? :
Can suppliers claim that their goods or services meet ISO 9001? :
No. The reference to ISO 9001 indicates that the supplier has a quality management system that meets the requirements of ISO 9001. As mentioned earlier, this should provide you with confidence in your supplier’s ability to provide consistent, conforming goods or services. ISO 9001 requires your supplier to monitor the levels of satisfaction of its customers (this includes you!), and to feed back this information in order to improve the effectiveness of its QMS.