In order to achieve ISO 9001certification an organisation needs to establish, document and implement a quality management system. The quality management system should be supported to ceaselessly improve its efficacy in accordance with legislation, global standards and best industry practice. The techniques that contribute to reaching the requirements of these standards should be determined.
The range of the Quality Management System certification must be obviously outlined. Should the organisation outsource any process which will affect product conformity to the outlined standards of the Quality Management System then the organisation should presume control over this process.
The quality management system processes and their interdependance must be recorded. Essential procedures for an efficient quality management system consist of document control, record control, management commitment, quality policy, responsibility and authority, management review, resources and training, infrastructure and work environment, design and development, purchasing, product realisation, identification and traceability, client property, measurement and monitoring, customer satisfaction, internal audit, control over non-conforming product, corrective action, preventive action and improvement. The factors and strategies required to guarantee that the operation and control over these processes are efficient should be documented in these techniques.
The least amount of records required for the quality management system to achieve the ISO 9001 standard will be management review minutes, training records, product release records, design and development records, provider assessment record, validation records, identification and traceability records, a register of purchaser property, calibration records, internal audit records, records of non-conforming product, corrective action records and preventative action records.
Quality management system procedures must be bolstered by 2nd tier documents as required depending on the dimensions of the operation, the complexness of the operation and the information base level of the personnel. Such paperwork can consist of work instructions, specifications, inspection timetables, risk analysis and job descriptions. Quality Management system documentation can take many different forms including, paper, electronic, diagrams, process flow charts and photographs.
Measurement, monitoring and review of the quality management system must be carried out by analysis of information from analytical tests, complaints analysis, quality performance indicators, exception reports, results of Inspections, results of Internal audits and the result of external audits. Steps should be taken in response to results to correct and stop inadequacies and to raise the usefulness of the quality management system.
The organisation needs to appraise the resources required to install, maintain, and improve the Quality Management System and these resources should be supplied. Resources should consist of talented staff, acceptable appliances, acceptable hardware and software, infrastructure, data, finances, audit resource and teaching.
Senior Management should be responsible for implementing, maintaining, reviewing and enhancing the quality management system. A member of the senior management team must be appointed the management representative.
Frequent management assessments should be conducted by the senior management team to guarantee performance is monitored and analysed. Review outputs must consist of quality policies objectives. The outputs of management assessments must be published and communicated to all staff to make sure focus is maintained on meeting policies, objectives and on continual improvement.