ISO 9001:2008 specifies requirements for aquality management system where an organization

• needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
• aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

Summary of ISO 9001:2008 in informal language

• The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs.
• The quality policy is understood and followed at all levels and by all employees. Each employee works towards measurable objectives.
• The business makes decisions about the quality system based on recorded data.
• The quality system is regularly audited and evaluated for conformance and effectiveness.
• Records show how and where raw materials and products were processed to allow products and problems to be traced to the source.
• The business determines customer requirements.
• The business has created systems for communicating with customers about product information, inquiries, contracts, orders, feedback, and complaints.
• When developing new products, the business plans the stages of development, with appropriate testing at each stage. It tests and documents whether the product meets design requirements, regulatory requirements, and user needs.
• The business regularly reviews performance through internal audits and meetings. The business determines whether the quality system is working and what improvements can be made. It has a documented procedure for internal audits.
• The business deals with past problems and potential problems. It keeps records of these activities and the resulting decisions, and monitors their effectiveness.
• The business has documented procedures for dealing with actual and potential nonconformance (problems involving suppliers, customers, or internal problems)