Q: I am looking for an interpretation for ISO 9001:2008 Quality management systems–Requirements, clause 4.2.4 Control of records: “Records shall remain legible, readily identifiable and retrievable.”
What is considered readily retrievable (i.e., 24 hrs, 48 hrs, 8 hrs, 1 hr)? I have a customer who thinks traceability records should be available within an hour of a request. I interpret readily as 24 hrs. The current ISO and TS specifications do not indicate a time, so a reasonable time to me is 24 hrs to pull the information together.
In addition, the customer’s supplier requirements also do not have any specified time for document retrieval. I did contact our third party registrar auditor and he indicated that 24 hrs would be considered readily retrievable as long as there were no customer specific requirements.
A: There appears to be some confusion between records being “readily retrievable” vs. a customer’s request for the delivery of copies of records. These are two separate issues.
The first issue: What is meant by “readily retrievable?” ISO 9001 does not prescribe any specific timeline or define the term “readily retrievable.” However, the intent of this requirement is to ensure that objective evidence is available to provide proof of conformance or evidence that requirements have been met. If the organization is unable to provide records upon request during an audit, the auditor will very likely document this as a nonconforming condition. Records must be available upon demand.
The second issue is response time to customer requests for records. Although records or evidence of conformance may be “readily retrievable” within the organization, the response time needed for an organization to provide copies of records to a customer may vary based upon the organization’s work load and availability of resources. So, it may take an organization an hour, a day or a week to deliver copies of records to a customer. In the event that the timely delivery of records is critical, requirements for the delivery of records should be stated in a contract or in a PO to provide a timeline or a delivery schedule. The delivery of copies of records or documents to customers is not addressed in ISO 9001, clause 4.2.4.
ASQ Senior Member
Managing Director of Aston Technical Consulting Services