ITIL : Food Safety Modernization Act ISO mentioned above Medical device manufacturing….

ITILITIL : Food Safety Modernization Act ISO mentioned above Medical device manufacturing….

Reproduction Document/image reproduction is key when thinking about implementing a system.

It’s all well and good being able to put things in, but how are you going to get it out? An example of this is building plans.

How will plans be scanned and scale be retained when printed? Document management system 3 Standardization Many industry associations publish their own lists of particular document control standards that are used in their particular field.

Following is a list of some of the relevant ISO documents.

Divisions ICS 01.140.10 and 01.140.20.[5] [6] The ISO has also published a series of standards regarding the technical documentation, covered by the division of 01.110.[7] ISO 2709 Information and documentation — Format for information exchange ISO 15836 [8] Information and documentation — The Dublin Core metadata element set ISO 15489 [9] Information and documentation — Records management ISO 21127 [10] Information and documentation — A reference ontology for the interchange of cultural heritage information • ISO 23950 Information and documentation — Information retrieval (Z39.50) — Application service definition and protocol specification • ISO 10244 [11] Document management — Business process baselining and analysis • ISO 32000 Document management — Portable document format • • • • Document Control Compliance adds requirements that transform document management into a document control issue.

Document control is a regulatory requirement within accounting (e.g., 8th EU Directive, Sarbanes-Oxley), food safety (e.g., Food Safety Modernization Act), ISO (mentioned above), Medical device manufacturing (FDA), Healthcare (JCAHO), and Information technology (ITIL)[12] .

Your documents — procedures, work instructions, policy statements, etc.

— provide evidence of documents under control .

Failing to comply could cause fines, the loss of business, or damage to your business reputation.

The basic requirement for document control require that you establish and document a procedure for: Reviewing and approving documents prior to release Reviews and approvals Ensuring changes and revisions are clearly identified Ensuring that relevant versions of applicable documents are available at their “points of use” Ensuring that documents remain legible and identifiable Ensuring that external documents like customer supplied documents or supplier manuals are identified and controlled • Preventing “unintended” use of obsolete documents • • • • • • References [1] Papergear: Electronic Document Management Systems, (http:/ / www.

papergear.

com/ xerox-news/ electronic-document-management-systems.

html?SSScrollPosition=0) [2] International Organization for Standardization.

“01.140.40: Publishing” (http:/ / www.

iso.

org/ iso/ products/ standards/ catalogue_ics_browse.

htm?ICS1=01& ICS2=140& ICS3=40& ).

.

Retrieved 14 July 2008.

[3] International Organization for Standardization.

“35.240.30: IT applications in information, documentation and publishing” (http:/ / www.

iso.

org/ iso/ catalogue_ics_browse?ICS1=35& ICS2=240& ICS3=30& ).

.

Retrieved 14 July 2008.

[4] OnSphere Corporation.

“SOP Document Management in a Validated Environments” (http:/ / www.

avidoffice.

com/ docushare/ dsweb/ Get/ Document-9101/ Standard Operation Procedure (SOP) Document Management in Validated Environments.

pdf).

.

Retrieved 25 April 2011.

[5] International Organization for Standardization.

“01.140.10: Writing and transliteration” (http:/ / www.

iso.

org/ iso/ products/ standards/ catalogue_ics_browse.

htm?ICS1=01& ICS2=140& ICS3=10& ).

.

Retrieved 14 July 2008.

[6] International Organization for Standardization.

“01.140.20: Information sciences” (http:/ / www.

iso.

org/ iso/ products/ standards/ catalogue_ics_browse.

htm?ICS1=01& ICS2=140& ICS3=20& ).

.

Retrieved 14 July 2008.

[7] International Organization for Standardization.

“01.110: Technical product documentation” (http:/ / www.

iso.

org/ iso/ products/ standards/ catalogue_ics_browse.

htm?ICS1=01& ICS2=110& ).

.

Retrieved 15 July 2008.

[8] http:/ / www.

iso.

org/ iso/ iso_catalogue/ catalogue_tc/ catalogue_detail.

htm?csnumber=52142 Document management system [9] http:/ / www.

iso.

org/ iso/ iso_catalogue/ catalogue_tc/ catalogue_detail.

htm?csnumber=31908 [10] http:/ / www.

iso.

org/ iso/ iso_catalogue/ catalogue_tc/ catalogue_detail.

htm?csnumber=34424 [11] http:/ / www.

iso.

org/ iso/ iso_catalogue/ catalogue_tc/ catalogue_detail.

htm?csnumber=45935 [12] Anderson, Chris.

Is Document Control Really That Important? (http:/ / www.

bizmanualz.

com/ blog/ standards/ is-document-control-really-that-important.

html), Bizmanualz, December 17th, 2010.

4 External links • Software/Document Management (http://www.dmoz.org/Computers/Software/Document_Management/) at the Open Directory Project • Miles L.

Mathieu, Ernest A.

Capozzoli (2002) (PDF).

The Paperless Office: Accepting Digitized data (http:// www.cabinetng.com/media/Paperless Office_Troy State.pdf).

Troy State University.

• Kevin Craine.

Excerpts from Designing a Document Strategy (http://www.document-strategy.com/excerpts.

html).

Craine Communications Group.

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