Quality Management and ISO 9001
If you need help to introduce a Quality Management System (QMS), develop it to ensure it meets requirements of ISO 9001 (the standard for quality management), and ensure that it leads to improvement to the product and service (with greater efficiency and reduced costs), contact bradQual.
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 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.
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 . . .
To determine whether the quality management system (QMS) is fit for purpose and complies with ISO 9001 the organisation must conduct internal audits of its processes. Each audit must be conducted by someone who is independent . . .
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.
Control of Documents
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.
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…
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…