Document Management - White Paper (ID 5277).pdf Jul. 2014 | Page 39

In order to gain certification, design, engineering, production, and quality control procedures need to be documented in periodic reports. A document management system can help firms by ensuring technical instructions are easily retrievable and upto-date as well as by generating the documentation needed for certification. Automated forms and document templates can aid in the proper completion of each documentable task, and create a reliable audit trail. More than one million organizations in 175 countries have implemented ISO rules for document handling over the last decade. Workflow and indexing tools of document management systems can help ISO-certified organizations in these basic objectives: • Approve documents before they are distributed. • Review/approve/update items on a periodic basis. The ISO 9001:2008 standard specifies requirements for a quality management system when an organization: • Make the correct version of document available at point of use. • needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and • Identify the current revision status of documents. • Retrieve, control, and monitor documents externally. 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. • Prevent the accidental/unintended use of obsolete documents. • Preserve the usability of documents. • Bentley Instruments Scientific supplier finds simple way to control ISO documentation Henrik Lyder, principal of Bentley Instruments, discovered a demand for his specialized technology all over the globe, or at least wherever there exists a population of cows. The staff in the Minnesota office began to engineer Bentley’s line of milk testing equipment according to international standards. Today, the company has a new office in Europe and dairy customers in more than 30 countries worldwide with exports constituting 70 percent of its sales. With its entrance into the global market, however, came from the need to achieve International Organization for Standardization (ISO) certification. “Through the process of becoming certified, we realized we didn’t have adequate control of our paper flow,” Lyder says. Scanning the ISO documents into digital form did not quite solve all the problems. Bentley needed a more systematic way to track, share, and retrieve ISO guidance, as well as related part and product information. Since standards are updated over time, engineers in Minnesota and support staff in Europe needed to know they were both using the correct guidance. Different teams working off of different standards would constitute a serious loss of time and money. Bentley deployed the M-Files document management solution that featured remote access for multiple locations and the metadata capabilities to index both instrument designs and ISO documents accordin