Iso 9001 2000 quality manual and procedures

We knew to do this based on our audit training, but now it is spelled out as a requirement. ISO states the auditor must be independent of those with direct responsibility for the audited activity. The new standard says the auditor must be impartial and objective, and that the auditor cannot audit their own work. The revised text may give small organizations more latitude in assigning auditors.

Although ISO requires an internal audit procedure, the new standard specifies the procedure must define responsibilities and requirements for planning and conducting audits, reporting results, and maintaining records. The organization must ensure any nonconforming product is identified and controlled to prevent its unintended use or delivery. These activities and related responsibilities and authorities must be defined in a documented procedure.

The ISO standard identifies several actions that might be taken to deal with nonconforming product. The product could be reworked, accepted by concession, regraded, or rejected or scrapped. The new standard covers these actions in different words. Clause 8.

When the new standard refers to actions to preclude the original intended use or application of the nonconforming product, it covers rejecting or scrapping. Both of the standards refer to concessions as an option. However, there is a new requirement that for any nonconforming product detected after delivery or use, the organization take action appropriate to the effects, or potential effects, of the nonconformity.

Be sure to address this possibility in your procedure. The organization must take corrective action to eliminate the cause of the nonconformity and prevent recurrence. Corrective action must be appropriate to effects of the problem. The documented procedure for corrective action must define requirements for:.

Although worded differently throughout the clause, the requirements are basically the same. Some auditors have expressed a concern that 8. They point out that clause 4. The organization must determine the action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions must be appropriate to the anticipated effects of the potential problem. The documented procedure for preventive action must define requirements for:.

Most organizations have a combined corrective and preventive action procedure. Although the new standard identifies the need for a corrective action procedure and a preventive action procedure, they can be placed together if the resulting procedure addresses the unique differences of their requirements.

All Rights Reserved. This approach may cause auditors to adjust their auditing techniques and focus more on interviewing individuals and observing operations. However, you need to do what is best for your business, which may be to reduce the amount of documentation compared to your current system.

Although not required, some organizations may choose to revise their quality manual to reflect the new clause structure of ISO The quality manual must address the scope of your system and provide the details of any excluded requirements. In addition, it must describe the interaction between processes and include or reference the procedures.

Only six procedures are specifically required by the new standard: Control of Documents 4. Although these procedures are part of current systems, they will need to be revised to incorporate the new and changed requirements of ISO The other procedures required by ISO , e. However, defined processes for these areas are still necessary and must comply with the requirements. Many organizations will see the business value in retaining and revising their existing procedures.

Abstract ISO specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.

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