ISO 9001

This is a summary of ISO 9001:2008 in informal language ISO:9001 is the version of ISO 9000 amended in 2008. The most recent Australia/New Zealand version is 2006.

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1. The quality policy is a formal statement from management:
   1. It is closely linked to the business and marketing plan and to customer needs.
   2. The quality policy is understood and followed at all levels and by all employees.
   3. Each employee needs measurable objectives to work towards.
 
2. Decisions about the quality system are made based on recorded data, and the system is regularly audited and evaluated for conformance and effectiveness.
 
3. Records show how and where raw materials and products were processed, to allow products and problems to be traced to the source.
 
4. The business determines customer requirements and creates systems for communicating with customers about product information, inquiries, contracts, orders, feedback, and complaints.
 
5. When developing new products:
   1. The business plans the stages of development, with appropriate testing at each stage.
   2. The business must test and document whether the product meets design requirements, regulatory requirements, and user needs.
 
6. The business regularly reviews performance through internal audits and meetings.
   1. It must determine whether the quality system is working and what improvements can be made.
   2. It must deal with past problems and potential problems.
   3. It must keep records of these activities and the resulting decisions, and monitor their effectiveness.
   4. It needs a documented procedure for internal audits.
 
7. The business has documented procedures for dealing with actual and potential non-compliances (problems involving suppliers or customers, or internal problems).
 
8. The business:
1. makes sure that no one uses bad product,
2. determines what to do with bad product,
3. deals with the root cause of the problem, and
4. keeps records to use as a tool to improve the system.