ISO Certification
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ISO 9001: 2008
Clauses Description: ISO 9001: 2000
  • 8.3 Control of Nonconforming product The standard requires you to have ways to identify a product or service nonconformity and to decide what to do about it. You need to have a documented procedure describing how you comply with the requirements and to record any such activities. When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.
  • 8.4 Analysis of Data Analysing data is an essential activity for any possible improvement in the quality management system, in the processes and in the product/service. The organisation shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information on customer satisfaction; conformity of product/service requirements; characteristics and trends of processes and products including opportunities for preventive action; and suppliers.
  • 8.5.1 Continual Improvement Continual improvement is the process of taking actions on a recurring basis to implement agreed solutions that should bring positive benefits. The organisation shall continually improve the effectiveness of the QMS through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
  • 8.5.2 Corrective Action Corrective action is an important improvement activity. Corrective action identifies measures needed to correct identified problems. It seeks to eliminate permanently the causes and consequent effects of problems that could have a negative impact on business results; the organisationís products/services, processes and QMS; and the satisfaction of customers. Corrective action involves finding the cause of a particular problem and then putting in place the necessary actions to prevent it from recurring.
  • 8.5.3 Preventive Action Preventive action seeks to prevent the occurrence of potential problems that could have a negative effect on business results, products/services, processes, QMS or customer satisfaction. A documented procedure shall define requirements for determining potential nonconformities and their causes; evaluating the need for action to prevent occurrence of nonconformities; determining and implementing action needed; records of the results of action taken; and reviewing preventive action taken.

  • ISO 9001:2008 main changes
  • Reinforcement of Control over outsourced processes that affect product conformity to requirements
  • Management representative has to be a member of the organization management and not an external individual
  • Competence of all personnel affecting conformity to product requirement must be controlled by the organization
  • Additional guidance to explain the different methods on measuring and monitoring customer satisfaction
  • For internal audits, the management of the audited unit must ensure that necessary corrections and corrective actions are taken
  • Clarification that information systems are included as part of the company infrastructure, and therefore the management system
  • New requirement to review the effectiveness of corrective and preventive actions

    The transition to this new revision will be performed either during your next surveillance audit or your next recertification and no later than 15th of November 2010

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