SharePoint Based ISO 9001 Document Management System
In today’s economy, providing a product of the highest quality will help differentiate your product line from your competitor’s, and provide a strategic advantage. Many customers are now demanding that their suppliers conform to the ISO 9001: 2008 standard.
From www.iso.org, “The ISO 9001:2008 standard specifies requirements for a quality management system where an organization
- needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
- aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
ISO 9001:2000 and ISO 14001: 2004 were implemented by more than a million organizations in 175 countries.”
Satisfying and implementing all the requirements of the ISO standard is a large undertaking and requires the support of the entire organization. The intent of this article is to describe how Microsoft Office SharePoint Server 2007 can be used as a tool during this undertaking, specifically in satisfying the requirements stated in Section 4.2.3 Control of Documentation. The aforementioned section of the ISO standard offers guidance for the requirements (represented by “”) that must be met in regards to control of documents throughout their life cycle, and is summarized below, along with SharePoint features (represented by “”) that may be utilized to satisfy these requirements:
- Documents must be approved before they are distributed.
- SharePoint’s fundamental building blocks of document libraries and workflow offer out of the box solutions (workflows) for approving documents. In some cases customization might be necessary to achieve the desired approval flows set forth by the quality policy, but in many cases the out of the box workflow will suffice.
- Documents must be reviewed/updated/re-approved on a periodic basis.
- SharePoint provides “Information Management Policies” (that are Content Type specific) that can automatically initiate workflows (based on document specific metadata). For example, the Information Management Policy for a document type of “Procedure” would automatically kick-off the “Document Review and Approval” workflow one year following the “Last Review Date” value for the document. Both the timeframe (e.g. days, months, years) and workflow triggered (e.g. Review, Approve, Archive, Delete) can be configured as needed.
- The correct version of document(s) must be made available at point of use.
- SharePoint offers several options to satisfy this requirement:
- A secured “Draft Working Library” may be utilized for content owners and authors to collaborate on documents before they are “published” to the “Final Document Library” that all members of the organization have view access to.
- Enabling “Document Version History” on a document library causes SharePoint to maintain a version of the document each time the document is updated. Major or Minor versions can be utilized, and authorized users can be granted access to see all revisions to the documents, whereas other users can be granted access to see only the latest version.
- The current revision status of documents is identified.
- “Document Version History” captures metadata properties associated with the document that might have changed from one version of the document to the next, along with the actual changes to the document itself. Since the entire document is saved as part of the revision history, this functionality can be used in conjunction with Microsoft Office Word 2007 and tools like “Compare Documents” and “Track Changes” to easily show changes from one version to the next. NOTE: Although these tools can be used to see updates that occurred between different versions of the document, it is still a best practice to include and maintain a Revision History section in the document itself.
- Identify, control and monitor documents from external sources.
- The open architecture with SharePoint allows integration with external sources:
- Documents that are received from external sources via email (or other electronic sources), can be transferred to SharePoint, and “tagged” with the appropriate metadata so that the same policies that are applied to internal documents can be applied to documents received from an external source.
- Documents that are received in hard copy form can be scanned/tagged and loaded into SharePoint. Features of this functionality are based on the scanning hardware/software utilized.
- Prevent the accidental/unintended use of obsolete documents.
- Many of the features already discussed above are utilized to satisfy this requirement, for example:
- Only the latest/approved version of documents are available for viewing by employees
- Information Management Policies may be used to archive/destroy documents based on the rules specified
- Preserve the usability of documents.
- The documents must remain legible (accomplished by storing the documents electronically) and easily identifiable (accomplished using the metadata properties associated with the document) which again are fundamental features of SharePoint.
Of course email notifications alerts, workflow to escalate tasks not being completed in a timely manner, auditing and the historical tracking of all the tasks as they are completed, is all native SharePoint functionality that facilitates the processes described above.
In order to be ISO 9001:2008 certified, your organization must develop and document a procedure to control quality documents. The requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Remember the guidance offered by the standard is prescriptive rather than descriptive. In other words, how you implement control of quality documents is up to you, as long as you show that you have satisfied the stated requirements.
In addition to using SharePoint to implement Quality Document Management Systems, Abel Solutions has also utilized SharePoint to implement Corrective Action (CA), Preventative Action (PA), and Management of Change (MOC) solutions for several of our clients, which are also requirements of the ISO 9001 standard.