ISO 9000 Compliance (Oracle Quality Help)


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ISO 9000 Compliance

ISO 9000 standards are a series of quality management standards proposed by the International Organization for Standards (ISO) in 1987. These standards require manufacturers to implement a quality management system to track products through the manufacturing process, inspect and test products, and document test procedures and results.

ISO 9000 is an evaluation of the consistency in execution and maintenance of internal operation procedures that directly affect a company's ability to produce high quality products and services.

ISO 9000 states that you must:

have a 'quality system' of some kind

document the processes that you use to guarantee that you create quality products or services (for example: your inspection operations, your production operations, how you determine and segregate defective products)

be able to prove that you have done what you've documented, typically through an ISO 9000 audit performed by an auditing organization

There are several PC-based products on the market that can help a company format and create a "Quality Manual" according to ISO 9000 guidelines. Many of these include templates which help you get started, suggest a format, suggest general topics to include and give you checklists to follow. Oracle Quality is not a Quality Manual creation product--but, if you already have such documentation in electronic form, you can attach these documents to Oracle Quality collection plans and specifications.

Oracle Quality can assist your ISO 9000 effort by providing an effective tool to collect details about product and process defects and to track dispositions and corrective actions. A large part of ISO 9000 is record-keeping -- records of your inspections, defects found, corrective actions taken, quality specifications, quality results you've collected, etc. Oracle Quality is essentially a quality record-keeping system to help you in this endeavor.

Oracle Quality can help manufacturers achieve and maintain ISO 9000 certification by documenting the quality standards associated with products and processes and by facilitating collection of results related to these standards. You can use the quality collection plan to define the critical quality data to collect and track, and to document the test and inspection instructions for each step. The collection plan helps ensure that the correct quality data is collected at the correct step and by the correct operator. You can use the quality specification to define critical collection elements and specification limits for specific items. In addition, you can use collection plan attachments and specification attachments to display your standard operating procedures and other relevant ISO 9000 documentation during quality data collection.

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