Although the Standard is copyrighted, and we cannot provide a copy here, we have summarized the major requirements of the standard. For critical decision making, be sure to refer to the actual Standard, which can be ordered from ASQ on-online.
Plan and carry out the inspection, test, measurement, analysis, and improvement activities needed to:
Monitor the end customers' opinion of your product and service. Determine how to gather and use this information.
Internal audits are verification activities performed by trained auditors within the organization. Their purpose is to determine how well the plans making up the QMS are being followed. The Standard requires internal audits be carried out regularly in each area covered by the QMS. Audits address conformity with the QMS, the requirements of ISO 9001:2000, and the effectiveness of the implementation.
Audit plans address:
Auditors are trained, objective, and never audit their own work.
Identified problems are quickly resolved by the manager responsible for area being audited.
Audit results are reported and recorded, follow up actions are verified.
Monitor and measure the performance of the processes that make up the QMS. Compare these actual results to the planned results. Take corrective action to make sure the product or service meets requirements.
During the production process, monitor and measure the product to assess if requirements are met. Keep records showing:
Nonconforming product is any product or service that does not meet requirements. Have documented procedures to identify nonconforming products and to make sure they are not used by accident. Define who is responsible for deciding what to do with a bad product. One of the following three actions must be taken:
Keep records of nonconformities.
Re-inspect any corrected products according to the procedures for new products.
Mitigate potential losses, perhaps by recall, from any product that has been found to be defective after its release to the customer.
The standard requires the organization to collect information on the functioning of the QMS. This information is then analyzed to evaluate the effectiveness and efficiency of your system and to identify opportunities for continual improvement of the QMS. Information collected and analyzed relates to:
Make use of the quality policy, quality objectives, audit results, data analysis, corrective and preventive actions and management review to improve the QMS.
When problems occur, fix the underlying process responsible for the defect. The thoroughness of each solution depends on how costly or unsafe the actual or possible problems are.
Create written procedures for:
The same actions described above for corrective actions must be considered for problems that have yet to occur. This is called preventive action. Effective preventive action involves identifying the potential problem, examining the root cause, putting a plan in place to prevent occurrence of the problem, evaluating the effectiveness of the plan, recording actions taken, and reviewing the preventive actions taken. A written procedure is required to describe the preventive action process.
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