Template Examples & Free ISO Downloads

The purpose of this ISO 9001 procedure is to define your organization’s responsibilities and activities in order to ensure that all inspection and test equipment used for product, service and process verification is controlled and calibrated against nationally traceable standards at specified intervals and that such devices are available to ensure continuity of measurement capability.

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Work instructions are low-level documents showing operational detail. They are optional.

Work instructions might describe how to operate machinery, how to mix chemicals for a certain process, how to process a purchase order, or anything else that you feel is important enough to document and share.

Many companies avoid over-burdening their quality manual by allowing lower-level documents, such as procedures and work instructions to contain the operational detail. Then, simple reference is made to the procedures and work instructions from within the quality manual itself.

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The purpose of this process is to define the activities required to ensure that product realization and planning encompasses the determination of product and process quality objectives, development of required processes, documentation and records.

Product quality objectives are defined in drawings and specifications, contracts, standards, samples, workmanship standards, and applicable legal and regulatory requirements.

Product realization planning includes the following:

• Definition and evaluation of production/service processes
• Development of suitable and capable processes
• Identification of special processes and consideration of associated risks and consequences
• Development and implementation of appropriate process control measures
• Development of instructions (where applicable) and training for process personnel
• Identification of the records required to demonstrate product/process quality

Product realization plans are generated collectively by the Production/Service, Engineering and Quality Functions. The plans are defined in associated production/service documents (e.g. process flowcharts, production/service work orders, process control plans, operator/installation instructions, process validation reports, etc.).

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