ISO 9001:2008 Record Availability Requirements

QUESTION:

From: An Inquiry From ASQ ‘s Ask the Experts Program
Sent: June 7, 2012
To: ATCS – Ask the Expert
Subject: ISO 9001:2008 QMS Requirements – Record Availability

During a recent second party audit, the customer’s Auditor asked to be provided with specific records for review.  This request was made near the end of a one day audit with less than an hour remaining in the audit.  The requested records were associated with parts produced 6-8 months earlier.  I do not think it is reasonable for the Auditor to expect 1-2 hour turn around on documents that are filed in two locations with one of them being off site.  What is considered to be an acceptable response time to provide requested records?

RESPONSE:

From: Bill Aston, ATCS –Q-Blog, Ask The Expert
Sent: Monday, June 8, 2012
To: ASQ Ask the Experts

The intent of ISO 9001:2008, clause 4.2.4, is to ensure records are readily available to provide evidence of conformance.  This means that records of conformity should be available upon demand or within an agreed time period.

ISO 9001:2008 does not prescribe a timeline for how long a supplier has to provide records of conformance.  Some Auditors may accept records that are submitted at least prior to the completion of the audit closing meeting.   However, unless it has been otherwise agreed between the Auditor and the Auditee, the audit is considered as completed after closing meeting has been conducted.  There is no ISO or other industry standard that provides a “grace period” (i.e., 1, 2, 8 or 24 hours) for the submitting audit evidence after the audit has been closed.

Even if records are located offsite, they should still be available to the Auditor via a fax or scanned into an email for verification at least prior to the conclusion of the onsite audit or closing meeting.

I hope this helps.

Best regards,

Bill Aston, Managing Director

Aston Technical Consulting Services, LLC