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Iso 9001 2000 audit

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Iso 9001 2000 audit

Iso 9001 2000 audit

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  • 1. Iso 9001 2000 auditWhich documents must I keep for ISO 9001?In addition to the legislative requirement for your business to keep certain records ISO9001 2000 requires your business to retain other records to demonstrate compliance withits various clauses.From an ISO 9001 2000 viewpoint records are documents generated whilst operatingyour Quality Management System. Typical examples are records of managementreviews, purchase orders, sales orders, test results and internal quality system audits.An ISO 9001 2000 consultant can be very helpful to your business in deciding whichrecords are required and those that are not.The standard is not specific about how long your business must retain each record but inorder not to fall foul of your own Quality Management System, or the law, you might liketo consider the following.If your business offers a period of (x) years guarantee with its product you must keepassociated records for at least (x) years.If your business sells products that have legislative requirements for product testing youmust keep associated records for the life of the product and sometimes longer.Any legislative requirement for you to keep records associated with your product orservice.Records can be in many formats including computer generated records such as thosemaintained by the Easy ISO 9001 2000® software package.It would be wise to remember when keeping computer based records for long periods(say 10 - 30 years) the medium upon which the data is stored will deteriorate andtherefore you must periodically validate its integrity.Another factor to consider with long term data storage is will a device still be available in30 years time to read the media upon which the data is stored?I still have computer programs on punch tape but I no longer have a punch tape reader!If you do not know what I am talking about here take it as validation of this advice.(Punch tape was a medium for storing computer programs and data in the 1960s and1970s)
  • 2. The following table identifies the specific records required by ISO 9001 2000. The listdoes not include records that your business might choose to retain voluntarily or thoserequired by legislative requirements for your product or service.Clause Document to retain, (Record)5.6.1 Minutes from your Quality Management Review meetings, including any actionsraised.6.2.2 Education, training, skills and experience.(Sub clause-e)7.1 Evidence that the realization processes and resulting product fulfill requirements.(Sub clause-d)7.2.2 Results of the review of the requirements relating to the product and actions arisingfrom the review.7.3.2 Design and development inputs.7.3.4 Results of design and development reviews and any necessary action.7.3.5 Results of design and development verification and any necessary action.7.3.6 Results of design and development validation and any necessary action.7.3.7 Results of the review of design and development changes and any necessary action.7.4.1 Results of supplier evaluations and actions arising from evaluations.7.5.2 As required by the organization to demonstrate the validation of processes wherethe resulting output cannot be verified by subsequent monitoring and measurement. (Subclause-d)7.5.3 The unique identification of the product, where traceability is a requirement.7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use.7.6 Standards used for calibration or verification of measuring equipment where nointernational or national measurement standards exist. (Sub clause-a)7.6 Validity of previous results when measuring equipment is found not to conform withits requirements.7.6 Results of calibration or verification of measuring equipment.8.2.2 Internal audit results.
  • 3. 8.2.4 Evidence of product conformity with the acceptance criteria and indication of theauthority responsible for the release of the product.8.3 Nature of the product non-conformities and any subsequent actions taken, includingconcessions obtained.8.5.2 Results of corrective actions.8.5.3 Results of preventive actions.If you want to download over free 50 ebook for iso 9001 standard, you can visit:http://iso9001ebooks.infoBest regards