Quality management system (QMS) in our company is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization’s purpose and strategic direction (ISO9001:2015). It is expressed as the organizational goals and aspirations, policies, processes, documented information and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling.
Quality system include:
- Management controls
- Design controls
- Production and process controls
- Corrective and preventative actions
- Material controls
- Records, documents, and change controls
- Facilities and equipment controls
Elements in our Organization:
- Quality objectives
- Quality manual
- Organizational structureand responsibilities
- Data management
- Processes – including purchasing
- Product quality leading to customer satisfaction
- Continuous improvement including corrective and preventive action
- Quality instruments
- Document control
Process:
QMS process is an element of our organizational QMS. The standard requires organizations seeking compliance or certification to define the processes which form the QMS and the sequence and interaction of these processes.
Processes include:
- order processes,
- production plans,
- product/ service/ process measurements to comply with specific requirements statistical process control and measurement systems analysis,
- calibrations,
- internal audits,
- corrective actions,
- preventive actions,
- identification, labeling and control of non-conforming products to prevent its inadvertent use, delivery or processing,
- purchasing and related processes such as supplier selection and monitoring