Quality Management Systems
ISO 9001 is a quality management standard. It applies to all types of organizations no matter what size they are or what they do. It can help both product and service organizations achieve standards of quality that are recognized and respected throughout the world.
The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee is given measurable objectives to work towards.
Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness.
Records should show how and where raw materials and products were processed, to allow products and problems to be traced to the source.
You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints.
When developing new products, you need to plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, regulatory requirements and user needs.
You need to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. Deal with past problems and potential problems. Keep records of these activities and the resulting decisions, and monitor their effectiveness (note: you need a documented procedure for internal audits).
You need documented procedures for dealing with actual and potential nonconformances (problems involving suppliers or customers, or internal problems). Make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem seeking and keep records to use as a tool to improve the system.
If you have not already done so, we recommend that you start preparing now by purchasing a copy of the draft or final revisions to the standard.
Benefits of ISO 9001
It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9001:2008 are also sound, according to Wade and Barnes, who say that "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive implementing ISO often gives the following advantages:
- Create a more efficient, effective operation
- Increase customer satisfaction and retention
- Reduce audits
- Enhance marketing
- Improve employee motivation, awareness, and morale
- Promote international trade
- Increases profit
- Reduce waste and increases productivity