The concept of document control technology is integral to ISO 9000. Specifically ISO 9001: 2008, requires the establishment of a document control system that stores and manages documents relating to implementing, maintaining, and continually improving a quality management system. Within the context of ISO 9000, a quality system must be documented and quality records must be maintained. Document control helps ensure effective operation and facilitates better decision-making, by providing a vehicle for employees, customers, and partners to access controlled documentation from any location at anytime.
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For high-tech companies that adhere to ISO 14000 environmental management standards, document control technology and quality procedures are equally necessary to help them continuously improve their environmental management system.
High-tech companies usually find it difficult to manage operations using a paper-based or hybrid system. For this reason most of these companies are gradually turning toward implementing a document control technology solution that provides the platform for controlling processes in an organized manner. MasterControl Documents is an advanced solution for document control that is integrated with the entire MasterControl suite of quality management software solutions. It is a configurable and easy-to-use software that helps high tech companies attain and sustain ISO 9000 compliance.
The following section helps in illustrating how MasterControl Documents addresses some of the major challenges that manufacturing companies face in establishing and maintaining a document control system that conforms to ISO 9000, ISO 9001, and ISO 14000.
One of the challenges of any high-tech company is to migrate to a document control technology system from a typical paper-based solution. Initially, the process of migrating may seem more tedious and uneconomical. However, during the long-run companies with multiple facilities and employees in different locations will find that a paper-based system is inefficient, requiring tremendous man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during ISO audits.
One of the primary requirements of ISO 9001 is to maintain documentation of all the procedures that cover the key business areas. MasterControl's document control technology system provides with a web-based repository that helps in documenting all major SOPs in the business. Irrespective of any document type, the centralized database stores all the documents that can be accessed by users from virtually anywhere. The search and retrieval of documents is very simple and enables users to perform these operations without spending excessive time. Since the repository is online, it is readily available for access by authorized users. ISO 9001 also emphasizes a constant monitoring of processes to ensure they are effective and keep adequate record of these processes. MasterControl simply provides document control technology that is highly advanced for those professionals who work in highly regulated environments. Lastly, ISO 9001 stresses on facilitating continual improvement. This criterion is met by providing a document control technology solution that helps users in accessing documentation and building an understanding of various procedures for better manageability of the business. All these features ensure that the effectiveness of the processes is maintained to enhance maximum optimization of resources for the company.
As high-tech companies expand their business, they will realize that it is difficult to keep a track of documents. Many companies run the risk of manufacturing a product batch by using an out-dated version of an SOP as the new document is currently under review and yet to be approved by the required authority. Such a situation can lead to waste of resources, time and capital for the company. Even tracking down any document activity in a paper-based or hybrid-based system is difficult. In case a change is required in a document, the user must manually submit a change request. To arrange a meeting for discussing the change can be very difficult through this system. All these problems cause unnecessary delays in document approvals which means delay in manufacturing product. This entire situation for the company is by all means unacceptable which is why most companies are considering incorporating document control technology in their business.
ISO 9000 2008 Clause 4.2 demands for a solution that approves documents before distribution. MasterControl's document control technology is completely proficient in automating the routing, escalation and approval of documents. The concerned manager is sent the document for approval. In case the person is unavailable, the document is sent to the next person in line. This automation of escalating the document on a specific route ensures that the document is approved without any excessive delay. After signoff using electronic signatures, the document is then stored in the repository for the users to access and apply in their operations. This meets ISO 9000 2008 requirement of providing correct version of documents at points of use. The software helps in ensuring that once the document is being updated, it cannot be accessed by other users during that time frame. This helps in providing other users with the message that the SOP is currently being updated. The document is locked out from any updates for that time period. The editor of the user must also present with the reason for alteration in the document before checking it in the repository. Once the document is approved and available in the repository again, then other authorized users can view the document and apply it for performing respective operations.
Communication breakdown is likely to happen in companies that rely on disparate tools and processes to manage the quality system. Ineffective communication can lead to delays and poor results. The operations in high-tech companies are reliant on bridging the gap between employees and various sub-systems to ensure a smooth culmination of operations.
ISO 14000 requirements include storing and managing environmental policy which can easily be stored in MasterControl's web-based document control technology solution. ISO 14000 also stresses the importance of effective communication at various levels. This implies that the operation of any department should not be hampered because of the inability of other departments to accommodate in the respective department's tasks. ISO 14000 requires effectively managing and reporting a corrective action preventive action (CAPA). This requirement emphasizes the importance of integrating training with the document control processes. MasterControl Documents is an integrated solution that connects all quality sub-systems like CAPA, change management, audit, customer complaint, and training. For example, a customer complaint that warrants a CAPA will be immediately escalated. Any CAPA that results into a change will automatically invoke training once the change is approved.
To learn more about the Technology Document Control, please feel free to contact a MasterControl representative.