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-Do-Check-Act
The Plan-Do-Check-Act cycle describes the process by which an organization designs and makes a product, and determines whether it meets requirements.
- 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.
Quality Management
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.
ISO 9001, the International Standard for Quality Management, has been revised, the new version was published in September 2015. Any organisation which has a quality management system (QMS) approved to ISO 9001:2008 must review their systems . . .
Internal audits are conducted to determine whether the quality management system (QMS) meets the requirements of the organization and ISO 9001. Each audit must be conducted by someone who is independent . . .
The quality management system (QMS) must be reviewed by management, at planned intervals, to ensure it is effective and suitable for . . .
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.
The bradQual database provides . . .
Supplier evaluation
Every organisation depends on its suppliers. For an organisation to provide a quality product or service its suppliers must also provide quality products or services. Before placing an order with…
Document Control
Effective control of documents is essential for any organisation. The document control system must ensure that: the current version of each document is available to each person who needs to…