Increase efficiency, reduce errors, and gain market confidence with ISO 9001 certification issued by TÜV USA.
ISO 9001 is the most widely recognized international standard for quality management systems (QMS). It establishes requirements that help organizations ensure process standardization, continuous improvement, and greater customer satisfaction.
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.
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 9001:2015 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
A quality management system according to ISO 9001 is the ideal basis from which to demonstrate your competence and performance capability, both nationally and internationally. One fundamental advantage is that the standard can be applied across all sectors – both for production companies and service providers.
Often, several management systems exist within one organisation. In addition to quality management, these may concern environmental, energy and also occupational safety and health management. ISO 9001 can be combined with other certifications into an integrated management system through the "High Level Structure of Standards" (HLS).
Internal operating procedures and work processes and also allocation of responsibilities within the organisation are addressed, along with regulation of processes when working together with customers and business partners. This ensures global comparability and also compatibility with other management systems.
ISO 9001 has undergone complete revision in order to adapt to the increasing complexity of the markets and their environment. The focus of the new version of 2015 no longer lies on documentation, but on process outputs and their effectiveness. In addition, the new version of ISO 9001 allows organisations greater flexibility with regard to implementation of their management systems. For example, the standard has adapted to today’s business reality by opening the possibility of computer- or web-based documentation.