What should be included in the Quality System regarding records ? General Records Guidance is given in EN 13980 on what records should be kept, but no specific time is stated. Product life has traditionally been used as an appropriate factor when making this decision, and product liability is clearly another. Our auditors will not insist on particular retention periods, but will look for them being specified and will question any that appear to be too short given the type of product. Non-conforming product : EN 13980 – 8.3 e) includes a requirement to keep certain records for a minimum period of 10 years, in situations where non-conforming product has been supplied to a customer, i.e.: - Serial numbers or identification of products supplied
- The customer who received the product
- The action taken to inform customers and the relevant notified body in the case of a non-conforming product
- The action taken to implement corrective and preventative action
Regulatory Requirements (ATEX) There are some requirements in the ATEX Directive regarding records to be kept for a period ending at least 10 years after the last product is manufactured. This depends on the Conformity Assessment Modules that apply, but examples are:
Annex III paragraph 9. “Technical Documentation and copies of Notified Body certificates and variations, i.e.
- Type Examination certificates and variations
- Certified Schedule Drawings
- Notified Body Certification or Test Reports
Annex IV, paragraph 5. The documentation of the quality system, updating the quality system, decisions and reports of the notified body. Please note that this requirement has been discussed by the European Commissions ATEX Standing Committee which has issued the following statement: “It is the opinion of the ATEX Standing Committee that the requirements in Annex IV, paragraph 5 of the ATEX Directive 94/9/EC are fulfilled if the manufacturer keeps at the disposal of the national authorities at least the actual quality management system documents plus the following documents which have to be kept for a period ending at least 10 years after the last piece of equipment was manufactured: - audit reports and certificates of the ISO 9000 certifier. This will be one or two reports per year that include the actual state at that moment of the quality system with changes:
- audit reports and notifications of the notified body that issued the Production Quality Assurance Notification. The above consideration is against the background that this documentation shall always be sufficient so as to enable surveillance authorities to determine that the relevant conformity assessment procedure(s) was/were applied in a satisfactory manner and that the relevant obligations of the ATEX Directive 94/9/EC were fulfilled.”
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