Iso doc 9001 2000 filetype doc

It must be established and maintained with:. Although not specifically required in the quality manual as before, providing an outline of the structure of your documented system would be a good idea. Also, the new standard no longer says the quality manual must cover all the requirements of the standard. However, if all the requirements are not addressed, it would appear that they have been excluded from your system.

The format and structure of the quality manual is up to the organization and depends on the size and complexity of their system. Of course, ordering the sections by the clause numbers of the new standard will make it easier to ensure no requirements are overlooked.

You want it to convey your management commitment to quality and represent your organization well. ISO clause 4. Six documented procedures are identified in the standard 4. Some organizations may find it convenient to combine the procedures for several activities into a single procedure, for example, corrective action and preventive action.

Others may choose to document an activity with more than one procedure, for example, internal audits. Documents required by the quality management system must be controlled. A documented procedure must be established to define controls to:. Ensure that changes and current document revision status are identified. Ensure external documents are identified and their distribution controlled.

Apply suitable identification to obsolete documents if they are retained. Note that reviewing documents and updating them as necessary implies an ongoing review process to ensure your documents are valid and current. The version of the standard said the nature of document changes had to be identified, where practical. Changes should be identified in the document or an attachment. The new standard has added that documents must be legible and readily identifiable.

ISO also clarified that control of external documents includes the control of their distribution. Records required for the quality management system must be controlled. These records must be established and maintained as evidence of conformance to requirements and to demonstrate the effective operation of the quality management system.

Records must remain legible, readily identifiable, and retrievable. Although a few words have been dropped from the description of the activities addressed by the record control procedure, the basic intent is the same. Also, dropping the reference to maintaining pertinent subcontractor records, as well as, dropping the reference to making the records available for customer evaluation, does not in practice eliminate these requirements if the records are needed to show conformity or satisfy a contract.

The organization must conduct periodic internal audits to determine if the quality management system, conforms to planned arrangements, conforms to requirements of ISO , and is effectively implemented and maintained. A documented procedure must address the responsibilities and requirements for:. Prior audit results must now be considered when planning the audit program, in addition to considering the status and importance of the areas to be audited.

The new standard requires the audit criteria, scope, frequency and methods to be defined. 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. 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.

Status : Withdrawn. Publication date : Life cycle Previously Withdrawn. Final text received or FDIS registered for formal approval.

Proof sent to secretariat or FDIS ballot initiated: 8 weeks. Close of voting. Proof returned by secretariat. International Standard under systematic review. This may also interest you. We received ….