Summary of ISO 9001:2000
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.
You need a documented procedure to control quality documents in your company.
Everyone must have access to up-to-date documents and be aware of how to use
To maintain the quality system and produce conforming product, you need to
provide suitable infrastructure, resources, information, equipment, measuring
and monitoring devices, and environmental conditions.
You need to map out all key processes in your company; control them by
monitoring, measurement and analysis; and ensure that product quality objectives
are met. If you can’t monitor a process by measurement, then make sure the
process is well enough defined that you can make adjustments if the product does
not meet user needs.
For each product your company makes, you need to establish quality objectives;
plan processes; and document and measure results to use as a tool for
improvement. For each process, determine what kind of procedural documentation
is required (note: a “product” is hardware, software, services, processed
materials, or a combination of these).
You need to determine key points where each process requires monitoring and
measurement, and ensure that all monitoring and measuring devices are properly
maintained and calibrated.
You need to have clear requirements for purchased product.
You need to determine customer requirements and create systems for communicating
with customers about product information, inquiries, contracts, orders, feedback
When developing new products, you need to plan the stages of development, with
appropriate testing at each stage. You need to test and document whether the
product meets design requirements, regulatory requirements and user needs.
You need to regularly review performance through internal audits and meetings.
Determine whether the quality system is working and what improvements can be
made. Deal with past problems and potential problems. Keep records of these
activities and the resulting decisions, and monitor their effectiveness (note:
you need a documented procedure for internal audits).
You need documented procedures for dealing with actual and potential
nonconformances (problems involving suppliers or customers, or internal
problems). Make sure no one uses bad product, determine what to do with bad
product, deal with the root cause of the problem and keep records to use as a
tool to improve the system.