Q: "In this age of electronic documents and records maintenance, what controls are appropriate to satisfy the requirements of ISO 9001:2000 section 4.2.3e, which requires controls, "...to ensure documents remain legible and readily identifiable?"

Jennifer and Frank Elias of JnF Specialties, LLC (www.quality-control-plan.com): "A two-prong approach is needed to address ISO 9001 4.2.3.e...
Establish a quality manual policy that reads:
'Electronic and hardcopy documents are controlled so that the information on them is accessible, legible and suitably maintained. Documents are reviewed and approved prior to release and only the latest versions are available to users.'

Establish a document control procedure that reads, in part:
'Documents may be distributed electronically through the Company's internet or intranet server. The Document Control Center may retain older hardcopies or electronic copies for historical purposes, but these are not available for general access.'
Documents must be controlled so that only reviewed and approved information is released and used by employees. This ensures that no mistakes are made due to the usage of obsolete information.
In some cases a hardcopy may be required. If the document is needed for more than thirty (30) days it is marked 'Released' and dated with the month and year of release by the Responsible Authority (RA). Each employee must then confirm that their stamped and released document is the latest revision prior to each use. If the document is not marked 'Released' it is marked with the date printed and expires thirty (30) days after printing.

Comment:
The most ISO-friendly documents are in electronic format because there is only one way for them to be uploaded for general access, which means their legibility will never be compromised and they are easy to identify.

Procedural Hint:
Its easy to survive an ISO audit for electronic documents. Simply store all 'released' documents in a directory named 'current' and all old versions in a directory named 'superseded.' Almost all servers are setup to require access via password, which means all 'released' documents are 'password-controlled' for an extra measure of management."

Colin Gray of Cavendish Scott, Inc.(www.cavendishscott.com): "While computers have made a huge difference to the 'legible' issue, there is still sometimes a problem. Poorly completed records (is that a one or a seven?) do, not infrequently cause errors to be made or at least to slow the process down., Unrecognizable signatures or initials are used to escape accountability. These potential issues still exist, should be of concern to organizations (at the appropriate level) and should be audited by the conscientious auditor.
'Identifiable' is a separate issue that computers also help with. While it was (and still is in many places) commonplace to put numbers on procedures this is technically not the point. A document needs to be identifiable so that it can be used. But the alternative situation is somewhat extreme. If it is not possible to identify a document then so long as it is not actually being used, then there is no problem. Throw it away. Computers have minimized this situation. Documents are often re-printed frequently or accessed on-line directly and identification is clear. The auditor still needs to check for identification and while the temptation will be to determine if identification is 'easy', this is the role of the auditee and care should be taken with this aspect."

Dan Nelson of Cavendish Scott, Inc. (www.cavendishscott.com): "A document (per ISO 9000:2000, 3.7.2) is 'information and its supporting medium.' ISO 9001:2000 4.2.3 tells us that a record is a special type of document. Electronic documents and records are every bit as valid as hard-copiesthe supporting medium just happens to involve electricity, hard-drives, networks, and/or servers. So, the full force of the requirements for legibility and identifiability apply. Hard-copy and hand-written quality management system (QMS) documents/records that are faxed, scanned, stored, or otherwise processed electronically are also subject to these requirements.

What good is any document/record if you cant decipher its information or you cant determine its purpose and/or what it pertains to? As long as the essential information can be gleaned from a document or a record, messy or garbled though it might be, it is arguably legible. It appears as if the authors of ISO 9001 are under the impression that using illegible documents might cause quality problems. Go figure. Its just common sense (like so many of the standards requirements) that documents and records are legible, regardless of their supporting medium.

Likewise for the requirement for documents/records to be readily identifiable. Users of electronic documents/records need to be able to determinewithout difficulty or undue opportunity for errorwhat any given controlled document or record is. A document/record that cannot be associated with the product or process to which it pertains/applies is as useless as an illegible document/record. Electronic documents residing on hard drives and servers are initially (if not officially) identified by filenames, which are often cleverly coded to reveal document type, approval authority, date of approval, revision level, etc. An electronic document/record might be also identified by its location in a designated folder or dedicated network server.

In conclusion, the distinction between an electronic document/record and its hard-copy counterpart is transparent in regard to the intent of the requirements of ISO 9001:2000 4.2.3e and 4.2.4. Thus, procedural requirements for document control dont need to explicitly address electronic documents in terms of their legibility and identifiability, as if they are somehow different from hard-copy records in this regard. By the same token, auditors do not need the treatment of electronic documents to be explicitly addressed by to apply these requirements to electronic QMS documents and records."

Andy Foss of Foss Quality Services, Inc. (www.fossqs.com): "Legible electronic documents:
.Be sure scanned documents are legible. The source documents need to be good and the resolution of the scanning must be appropriate. I have seen fine print on engineering drawings or contracts lost in the scanning process. Information in color must also be maintained when transferred to an electronic format.
. Document font size and screen size needs to be appropriate for the user.
. The users of electronic documents must be aware of how to use and access the documentation so that they can read it.
. The language must be understandable by the reader.

Readily Identifiable electronic documents:
. The document link and/or file name should be appropriate to the content so that it can be located when needed (easier is better!)
. If different versions are available, they should be clearly identified so that the correct one(s) are used.