Quality Management and ISO 9001
A Quality Product
The product or service provided by an organisation must be:
- Fit for its intended purpose
- Available when and where it is required
- Consistent, reliable and repeatable, and
- Meet the requirements of the customer.
When an organisation prepares to launch a new product it must identify the gap in the market, and determine the features and characteristics required by the potential customers and regulatory bodies. It must determine how it will provide the product and confirm it will meet requirements. It must review the product (and determine whether it meets requirements) and make changes to improve customer satisfaction, performance, serviceability and safety.
- Plan – Design the product
- Do – Manufacture, test and put on the market
- Check – Determine whether the product meets requirements
- Act – Improve the product based on feedback from consumers.
By applying Plan-Do-Check-Act the product can be continually improved to meet changing requirements of the market.
The purpose of a Quality Management System is to apply the Plan-Do-Check-Act cycle to the organisation and its processes, to ensure they are adequately resourced and managed, to identify opportunities for improvement and ensure they are acted on.
ISO 9001, the standard for Quality Management, is a set of requirements which can be applied by any organization (whether they are a manufacturer, provide a service to another organization or to the public).
A quality management system (QMS) can be reviewed by an accredited certification body (3rd party). If the QMS meets the requirements of the standard they will issue a certificate which identifies the products and services which the organisation provides, and the locations at which the QMS is implemented.
A certificate confirming the QMS meets the requirements of ISO 9001 gives confidence to customers that the organisation can provide products and services which are fit for purpose.
Each organisation must maintain documented information, ensure it is available for use, and provide data for analysis to determine whether objectives have been met. While it is possible to maintain information on paper, or in separate files on a computer, documents can be difficult to retrieve and analysis of data can be time consuming.
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