To gain ISO 9001certification an organisation wants to build, document and actualize a quality management system. The quality management system should be supported in order to repetitively improve its efficacy in accordance with legislation, world standards and best industry practice. The processes that contribute to reaching the requirements of these standards should be made clear.
The range of the Quality Management System ratification must be clearly defined. If the organisation outsource any process which will affect product conformity to the defined standards of the Quality Management System then the organisation should presume control over this process.
The quality management system processes and their interactions must be documented. 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, buying, product realization, identification and traceability, shopper property, measurement and monitoring, client satisfaction, internal audit, control over non-conforming product, corrective action, preventative action and improvement. The criteria and methods required to ensure that the operation and control of these processes are efficient should be documented in these processes.
The minimum records required for the quality management system to achieve the ISO 9001 standard would be management review minutes, coaching records, product release records, design and development records, supplier assessment record, validation records, identification and traceability records, a register of customer property, calibration records, internal audit records, records of non-conforming product, corrective action records and defensive action records.
Quality management system procedures must be supplemented by second tier documents as needed depending on the size of the organisation, the complicatedness of the operation and the data base level of the personnel. Such paperwork can consist of work instructions, specifications, inspection schedules, risk analysis and job outlines. Quality Management system paperwork can take many forms including, paper, digital, diagrams, process flow charts and pictures.
Measurement, monitoring and review of the quality management system must be done by research of data from analytical tests, complaints research, quality performance indicators, exception reports, results of Inspections, results of Internal audits and the results of external audits. Steps should be taken responding to results in order to correct and prevent inadequacies and to improve the usefulness of the quality management system.
The organisation wants to appraise the resources needed to implement, maintain, and improve the Quality Management System and these resources should be provided. Resources should consist of skilled staff, appropriate kit, appropriate hardware and software, infrastructure, information, finances, audit resource and training.
Senior Management should be responsible for implementing, maintaining, reviewing and enhancing the quality management system. A member of the senior management team must be allocated the management representative.
Frequent management reviews should be carried out by the senior management team to ensure performance is measured and analysed. Review outputs must consist of quality policies objectives. The outputs of management reviews must be released and communicated to all staff to make sure focus is maintained on meeting policies, objectives and on continuous improvement.