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Unit 10: Quality Management System

at all levels and by all employees. Each employee needs measurable objectives to work Notes
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.

ISO 9000 documentation includes procedures 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, ISO 9000 documentation
must 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.

Self Assessment

Fill in the blanks:

4. The …………………… is a formal statement from management, closely linked to the
business and marketing plan and to customer needs.
5. …………………… documentation stresses the need to regularly review performance
through internal audits and meetings.

10.3 Implementation

The steps involved in implementing ISO 9001: 2000 are explained below:
1. Top Management Commitment: The first and most important requirement for
implementing ISO 9000 is full commitment from top management. CEO and Board of
Directors must be committed to provide all the necessary resources for successful
implementation.

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