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ISO 9000
ISO 9000 is a family of standards for quality management
systems. ISO 9000 is maintained by ISO, the International Organization for
Standardization and is administered by accreditation and certification bodies.
Some of the requirements in ISO 9001 (which is one of the standards in the ISO
9000 family) include
- a set of procedures that cover all key processes in
the business;
- monitoring processes to ensure they are effective;
- keeping adequate records;
- checking output for defects, with appropriate and
corrective action where necessary;
- regularly reviewing individual processes and the
quality system itself for effectiveness; and
- facilitating continual improvement
A company or organization that has been independently
audited and certified to be in conformance with ISO 9001 may publicly state that
it is "ISO 9001 certified" or "ISO 9001 registered".
Summary of ISO 9001:2000 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 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 them.
- 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 and complaints.
- 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.
From Wikipedia, the free encyclopedia
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