- 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 needs measurable objectives to work towards.
- Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness.
- Records should show how and where raw materials and products were processed, to allow products and problems to be traced to the source.
- The business needs to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints.
- When developing new products, the business needs to plan the stages of development, with appropriate testing at each stage. It must test and document whether the product meets design requirements, regulatory requirements and user needs.
- The business needs to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. It must deal with past problems and potential problems. It must keep records of these activities and the resulting decisions, and monitor their effectiveness. It needs a documented procedure for internal audits.
- The business needs documented procedures for dealing with actual and potential nonconformances (problems involving suppliers or customers, or internal problems). It must make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem seeking and keep records to use as a tool to improve the system.
Stratasys recently announced that they’ve achieved ISO 9001:2008 certification. For those of you unfamiliar with the intricacies of ISO manufacturing certifications, this particular cert deals with policies and procedures used to develop manufactured products. While the actual ISO documentation is extensive, Wikipedia summarizes this standard using “informal language”:
As you can see, this is very extensive and deeply affects how a company operates. This is one of the factors that separates the large-scale commercial manufacturers such as Stratasys and 3D Systems from the emerging manufacturers like MakerBot, who really can’t yet attempt anything like ISO 9001:2008. But this may happen in the distant future if the MakerBots of the world continue to grow.