In addition to the legislative requirement for your business to keep certain records ISO 9001 2000 requires your business to retain other records to demonstrate compliance with its various clauses.
From an ISO 9001 2000 viewpoint records are documents generated whilst operating your Quality Management System. Typical examples are records of management reviews Authentic Kevin Hayes Jersey , purchase orders, sales orders Authentic Mika Zibanejad Jersey , test results and internal quality system audits.
An ISO 9001 2000 consultant can be very helpful to your business in deciding which records are required and those that are not.
The standard is not specific about how long your business must retain each record but in order not to fall foul of your own Quality Management System, or the law Authentic Mats Zuccarello Jersey , you might like to consider the following.
If your business offers a period of (x) years guarantee with its product you must keep associated records for at least (x) years.
If your business sells products that have legislative requirements for product testing you must keep associated records for the life of the product and sometimes longer.
Any legislative requirement for you to keep records associated with your product or service.
Records can be in many formats including computer generated records such as those maintained by the Easy ISO 9001 2000脙茠脝鈥櫭兟⒚⑩€毬吢∶兤捗⑩偓拧脙鈥毭偮?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 and therefore you must periodically validate its integrity. Another factor to consider with long term data storage is will a device still be available in 30 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 1960's and 1970's)
The following table identifies the specific records required by ISO 9001 2000. The list does not include records that your business might choose to retain voluntarily or those required by legislative requirements for your product or service.
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 arising from 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 where the resulting output cannot be verified by subsequent monitoring and measurement. (Sub clause-d)
7.5.3 The unique identification of the product, where traceability is a requirement.
7.5.4 Customer property that is lost Brady Skjei Jersey , damaged or otherwise found to be unsuitable for use.
7.6 Stan
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