Defining the Range of Quality Management System Certification
In order to achieve ISO 9001certification a business needs to create, document and actualize a quality management system. The quality management system should be supported in order to repetitively improve its effectiveness as per legislation, world standards and best industry practice. The systems that contribute to reaching the prerequisites of these standards should be made clear.
The range of the Quality Management System certification should be clearly defined. Should the organisation outsource any process that can affect product conformity to the defined standards of the Quality Management System then the organisation should take control over this process.
The quality management system processes and their interdependance should be documented. Essential procedures for an efficient quality management system include 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 realisation, identification and traceability, customer property, measurement and monitoring, customer satisfaction, internal audit, control of non-conforming product, corrective action, preventative action and improvement. The standards and strategies required to ensure the operation and control of these processes are useful should be documented in these procedures .
The least amount of records required in order for the quality management system to meet the ISO 9001 standard should be management review minutes, training records, product release records, design and development records, provider assessment record, endorsement records, identification and traceability records, a register of shopper property, calibration records, internal audit records, records of non-conforming product, corrective action records and defensive action records.
Quality management system procedures should be bolstered by 2nd tier documents as required depending on the dimensions of the organisation, the complexity of the operation and the knowledge base level of the personnel. Such documentation can include work instructions, specifications, inspection schedules, risk analysis and job descriptions. Quality Management system documentation can take numerous forms including, paper, electronic, diagrams, process flow charts and footage.
Measurement, monitoring and review of the quality management system should be done by analysis of data from analytical testing, complaints analysis, quality performance markers, exception reports, the outcome of Inspections, the outcome of Internal audits and the result of external audits. Steps should be taken replying to results in order to correct and prevent inadequacies and to raise the usefulness of the quality management system.
The organisation wants to assess the resources required to implement, support, and improve the Quality Management System and these resources should be provided. Resources should include skilled personnel, acceptable kit, acceptable hardware and software, infrastructure, information, finances, audit resource and teaching.
Senior Management should be accountable for implementing, maintaining, reviewing and improving the quality management system. An affiliate of the senior management team should be appointed the management representative.
Frequent management assessments should be conducted by the senior management team to ensure performance is monitored and analysed. Review outputs should include quality policies goal. The outputs of management assessments should be released and communicated to all personnel to make sure focus is maintained on meeting policies, objectives and on continuing improvement.
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